Current Issue : April-June Volume : 2015 Issue Number : 2 Articles : 42 Articles
Esomeprazole magnesium is chemically bis (5methoxy-2-[(S)-[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1Hbenzimidazole-1-yl) magnesium salt. It is used in treatment of gastric-acid related diseases as a proton-pump inhibitor (PPI). The objective of this review is to study various analytical methods using UV-Spectroscopy, HPLC for estimation of esomeprazole magnesium....
The quote of Charles Darwin “It’s neither the strongest of the species, nor the most intelligent, but the those that are most responsive to change that survive” surely applicable to Quality by Design (QbD) approach which means that in this era of competition where quality has been given prime importance one has to change the frizzed approach of analytical development to develop a product which is free from deficiencies. In the present review concept, call for i.e. need and constraints of analytical quality by design are discussed. In detail explanation of elements of AQbD i.e. Analytical Target profile, design of experiments and design space, method operable design region (MODR), risk assessment and method development are given. Applications of analytical quality by design (AQbD) in determination of impurity, in screening of column used in chromatography, in development of HPLC method for drug substances, in capillary electrophoresis, in stability studies, in UHPLC, in LC-MS method development, bio analytical method development and in dissolution studies is explained in detail by referencing examples....
The present work describes development and validation of stability indicating RP-HPLC method for simultaneous estimation of citicholine and piracetam in combined dosage form. The chromatographic separation was obtained by using a mobile phase comprised of phosphate buffer (pH-4.8) and methanol in the ratio 90:10 v/v using hyperchrome ODS C18 column (250 X 4.6 mm) with UV detection at 210 nm at a flow rate of 1 ml/min.The Rt was found to be 2.9 and 5.1 min for citicholine and piracetam respectively. The linearity of proposed method was tested in the range of 10-50 μg/ml for citicholine and 16–80 μg/ml for piracetam with correlation coefficients 0.998 and 0.999 respectively. The accuracy of the proposed method was determined by recovery studies and found to be 99.32% for citicholine and 99.28% for piracetam. The forced degradation study was carried out and degradation peaks are well resolved from the main peaks. The proposed validated stability indicating HPLC method for the simultaneous estimation of citicholine and piracetam in tablet dosage form was accurate, precise, linear, economic and robust. The developed method can be routinely adopted for analysis of citicholine and piracetam in the formulation....
Two simple spectroscopic methods have been developed for simultaneous estimation of Lamotrigine and Clozapine in synthetic mixture. Simultaneous equation method involves the measurement of absorption at two wavelengths 308 nm (max for Lamotrigine) and 259.60 nm (max for Clozapine). The method was found linear between the range of 1-5 µg/ml for Lamotrigine and 6-30 µg/ml for Clozapine for method.The accuracy and precision was determined and validated statistically. Both the method showed good reproducibility and recovery with %RSD less than 1.The method was found to be rapid, specific, precise and accurate and can be successfully applied for the routine analysis for Lamotrigine and Clozapine in bulk and combined dosage form....
The simple, accurate and precise absorption correction method has been developed for the simultaneous estimation of amitriptyline hydrochloride and methylcobalamin in combined tablet dosage form. The method utilizes distilled water as solvent and λmax of amitriptyline hydrochloride and methylcobalamin selected for analysis were found to be 239 nm and 351 nm respectively. The method was validated as per international conference on harmonization (ICH) guidelines. The linearity range lies between 20-60 µg/ml (R2 0.9998) for amitrityline hydrochloride and 3-9 µg/ml (R2 0.9990) for methylcobalamin. The accuracy and precision were determined and found to comply with ICH guidelines. The method showed good reproducibility and recovery with %RSD in desired range. The proposed method can be applied for routine analysis of both drugs....
A simple, rapid, precise, accurate and reproducible high performance liquid chromatographic method was developed for estimation of loteprednol etabonate in eye drops. Chromatographic separation of the drug was achieved on a bondapak C-18 (300 × 3.9 mm, 5µ) column (waters) using a mobile phase, methanol and water in the ratio of 80:20% v/v, at a flow rate of 1 ml/min. The detection was carried out at 234 nm. The drug was eluted at the retention time of 5.3±0.1 min. The calibration curve was linear over the range of 5 µg – 600 μg/ml. The performance of the method was validated according to ICH guidelines. The method can be applied for determination of drug in its formulation with good accuracy and precision....
A simple, precise and accurate reverse phase high performance liquid chromatography method for analysis of amitriptyline hydrochloride and methylcobalamin in tablet dosage form was developed and validated according to ICH guidelines. The quantification of the drug was carried out by using Hibar® C18 (250 X 4.6 mm, 5 μ) column and maintain column at 20°C, using mobile phase comprising of Dibasic sodium phosphate buffer: Methanol in the ratio of 70:30 % v/v (Adjust pH-6 with orthophosphoric acid), with a flow rate of 1.0 ml/min and the detection wavelength was carried at 218 nm. The retention time for amitriptyline hydrochloride and methylcobalamin was found to be 2.300 and 3.340. The content uniformity was found to be 98.69-101.58% and 98.99-102.42%. Proposed method was validated for precision, accuracy, linearity and range, specificity and robustness according to ICH Q2R1 guidelines. The method was successfully applied to amitriptyline hydrochloride and methylcobalamin their tablet dosage form....
A simple, accurate, precise and specific spectrophotometric method has been developed for simultaneous determination of racecadotril and ofloxacin in its combined tablet dosage form by using methanol as a solvent. The method involves solving of simultaneous equation based on measurement of absorbance at two wavelengths at 206.5 nm and 227.6 nm. Method follows Beer’s linearity in the range of 5-12 μg/ml for racecadotril and 10-24 μg/ml ofloxacin both. The mean % recoveries were found to be in the range of 99.04–101.4% and 98.85 – 101.6% for racecadotril and ofloxacin respectively. Limit of detection and quantitation was found to be 0.031 μg/ml and 0.096 μg/ml for racecadotril and 0.043 μg/ml and 0.131μg/ml for ofloxacin respectively. Assay results of market formulation were found to be 99.64% and 99.82% for racecadotril and ofloxacin respectively. The proposed method has been validated as per ICH guidelines and successfully applied to the estimation of racecadotril and ofloxacin in their combined tablet dosage form....
The aim of the present work was to develop and validate an accurate, stability indicating RP-HPLC method for the determination of abrisentan and its process impurities in bulk and dosage forms. The drug was subjected to different stress conditions, significant degradation was observed during acid hydrolysis and peroxide degradation. The chromatographic conditions were optimized using an impurity-spiked solution and forced degradation samples. The method was developed using Agilent XDB-C18 (150×4.5 mm, 5µ) column and 10 mM NH4OAc (pH 5.2 adjusted with acetic acid): ACN as the mobile phase with 1 ml/min flow rate and effluents were monitored at 289 nm. The sample was injected using a 20 μl fixed loop and the total run time was 45 min. The retention times were found as 25.945, 24.685, 23.83, 10.53, 5.11 and 3.48 min for IMP-1, IMP-2, IMP-3, AMP, IMP-4 and IMP-5 respectively. The linear ranges were found to be 50-150, 0.1- 2.25, 0.1- 2.25, 0.07- 2.25, 0.09- 2.25 and 0.25- 2.25 μg/ml for AMP, IMP-1, IMP-2, IMP-3, IMP-4 and IMP-5 respectively. The mean recovery values were found to be 98.52-100.44% for AMD and its impurities. The degradation rate of AMB in acid, base, peroxide (Oxidative) thermal and photolytic degradation processes was found in range 7-22%. The developed analytical method has been validated according to ICH guidelines. All the degradation products obtained by stress conditions were found to be well separated from the principal peak. The developed method was successfully employed for routine quality control and stability analysis of AMB in pharmaceutical dosage forms....
Fexofenadine hydrochloride is a new non-sedating oral antihistaminic which is clinically effective in the treatment of allergic rhinitis. As per Literature survey, there is no UV AUC method has been reported for estimation of fexofenadine HCl in bulk form and in pharmaceutical formulation. Hence an attempt has been made to develop and validate a simple, economic, rapid and accurate method. The linearity for this method was found to be in the range of 40-90 μg/ml. The calibration curve was drawn by plotting graph between AUC and concentration. Coefficient of correlation was found to be 0.9934. The regression of the curve was Y = 0.0093x + 0.9706. The lower limit of detection and the limit of quantification were found to be 6.87 μg/ml and 20.84 μg/ml respectively. The percentage recovery was found to be 94.99±0.3269....
Warfarin Sodium clathrate is an anticoagulant that inhibits the synthesis of vitamin K-dependent coagulation factors. As per literature survey, there is no UV AUC method has been reported for estimation of warfarin sodium clathrate in bulk form and in pharmaceutical formulation. Hence an attempt has been made to develop and validate a simple, economic, rapid and accurate method. The linearity for this method was found to be in the range of 10-30 μg/ml. The calibration curve was drawn by plotting graph between AUC and concentration. Coefficient of correlation was found to be 0.9999. The regression of the curve was Y = 0.0101x + 0.009. The lower limit of detection and the limit of quantification were found to be 0.1146 μg/ml and 0.5049 μg/ml respectively. The percentage recovery was found to be 97.09±0.2411....
The aim of present work was to develop an accurate, precise, reproducible and economical UV spectrophotometric area under curve method for estimation of tinidazole. This area under curve of UV spectrum between 301 to 321 nm was validated as per ICH guideline Q2 (R1). The method has followed linearity in the range of 5-30 μg/ml. The value of correlation coefficient was 0.997. Satisfactory values of percent relative standard deviation for the intra-day and inter-day precision indicated that method is precise. Results of the recovery studies (101.32% to 107.32%) showed accuracy of the method. LOD and LOQ were calculated as 0.6763 μg/ml and 2.049 μg/ml, respectively. The developed method can be used for routine estimation of tinidazole in bulk and tablet dosage forms....
The aim of present was to develop an accurate, precise, reproducible and economical UV spectrophotometric area under curve method for estimation of tramadol hydrochloride. This Area under curve of UV spectrum between 267 to 277 nm was validated as per ICH guideline Q2 (R1). The linearity for this method was found to be in the range of 60-160 μg/ml. The calibration curve was drawn by plotting graph between AUC and concentration. Coefficient of correlation was found to be 0.9967. The lower limit of detection and the limit of quantification were found to be 1.93 μg/ml and 5.84 μg/ml respectively. The percentage recovery was found to be 97.02±0.0681....
A simple, precise, accurate and economical UV visible spectrophotometric method has been developed for estimation of acebutolol hydrochloride drug by AUC method. The standard and sample solutions were prepared by using double distilled water as a solvent. Quantitative determination of the drug was performed at wavelength range 226-240 nm. The linearity was established over the concentration range of 05-25 µg/ml for acebutolol hydrochloride with correlation coefficient value of 0.9985. Precisionstudies showed that % relative standard deviation was within range ofacceptable limits. The mean percentage recovery was found to be 99.39%. The proposed method has been validated as per ICH guidelines....
A simple, precise, accurate and economical UV visible spectrophotometric method has been developed for estimation of cetrizine hydrochloride drug by AUC method. The standard and sample solutions were prepared by using double distilled water as a solvent. Quantitative determination of the drug was performed at wavelength range 226-234 nm. The linearity was established over the concentration range of 02-10 �µg/ml for cetrizine hydrochloride with correlation coefficient value of 0.9987. Precision studies showed that % relative standard deviation was within range of acceptable limits. The mean percentage recovery was found to be 96.83%. The proposed method has been validated as per ICH guidelines....
A simple, precise, accurate and economical UV visible spectrophotometric method has been developed for estimation of chloramphenicol drug by AUC method. The standard and sample solutions were prepared by using doubledistilled water as a solvent. Quantitative determination of the drug was performed at wavelength range 226-234 nm. The linearity was established over the concentration range of 5-25 µg/ml for chloramphenicol with correlation coefficient value of 0.9993. Precision studies showed that % relative standard deviation was within range ofacceptable limits. The mean percentage recovery was found to be 100.14%. The proposed method has been validated as per ICH guidelines....
A simple, precise, accurate and economical UV visible spectrophotometric method has been developed for estimation of fluoxetine hydrochloride drug by AUC method. The standard and sample solutions were prepared by using double distilled water as a solvent. Quantitative determination of the drug was performed at wavelength range 220-231 nm. The linearity was established over the concentration range of 05-25 µg/ml for fluoxetine hydrochloride with correlation coefficient value of 0.9987. Precision studies showed that % relative standard deviation was within range of acceptable limits. The mean percentage recovery was found to be 98.50%. The proposed method has been validated as per ICH guidelines....
A simple, precise, accurate, and economical UV visible spectrophotometric method has been developed for estimation of ibuprofen drug by AUC method. The standard and sample solutions were prepared by using double distilled water as a solvent. Quantitative determination of the drug was performed at wavelength range 218-226 nm. The linearity was established over the concentration range of 5-25 µg/ml for ibuprofen with correlation coefficient value of 0.999. Precision studies showed that % relative standard deviation was within range of acceptable limits. The mean percentage recovery was found to be 99.79%. The proposed method has been validated as per ICH guidelines....
A simple, precise, accurate, and economical UV visible spectrophotometric method has been developed for estimation of Oxcarbazepine drug by AUC method. The standard and sample solutions were prepared by using double distilled water as a solvent. Quantitative determination of the drug was performed at wavelength range 252-258 nm. The linearity was established over theconcentration range of 05-25µg/ml forOxcarbazepine with correlation coefficient value of 0.9985.Precision studies showed that % relative standard deviation was within range of acceptable limits. The mean percentage recovery was found to be 99.39%. The proposed method has been validated as per ICH guidelines....
Simple, fast and reliable spectrophotometric methods were developed for determination of cefadroxil in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in distilled water. The quantitative determination of the drug was carried out using the zero/0th, first and second order method values measured at 264, 268 and 268 nm respectively. Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of cefadroxil using 5-25 μg/ml (r² = 0.9991, r² = 0.9950, r² = 0.9976) for zero, first and second order spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. The developed methods were successfully applied to estimate the amount of cefadroxil in pharmaceutical formulations....
Simple, fast and reliable spectrophotometric methods were developed for determination of cefadroxil in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in distilled Water. The quantitative determination of the drug was carried out using the second order derivative area under curve method values measured at 264-272 nm. Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of cefadroxil using 5-10 μg/ml (r² = 0.9984) for second order derivative area under curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. The developed methods were successfully applied to estimate the amount of cefadroxil in pharmaceutical formulations....
Simple, fast and reliable spectrophotometric methods were developed for determination of Ondansetron Hydrochloride in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in Distilled Water. The quantitative determination of the drug was carried out using the zero/0th, first and second order method values measured at230, 234 and 234 nm respectively. Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Ondansetron Hydrochloride using 2-10 μg/ml (r²=0.9977, r²=0.9996, r²=0.9997) for zero, first and second order spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. The developed methods were successfully applied to estimate the amount of Ondansetron Hydrochloride in pharmaceutical formulations...
Simple, fast and reliable spectrophotometric methods were developed for determination of oxcarbazepine in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in distilled water. The quantitative determination of the drug was carried out using the zero/0th, first and second order method values measured at 256, 260 and 268 nm respectively. Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of oxcarbazepine using 5-25 μg/ml (r²=0.9980, r² = 0.9960, r² = 0.9983) for zero, first and second order spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. The developed methods were successfully applied to estimate the amount of oxcarbazepine in pharmaceutical formulations....
Simple, fast and reliable spectrophotometric methods were developed for determination of oxcarbazepine in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in distilled water. The quantitative determination of the drug was carried out using the second order derivative area under curve method values measured at 255-264 nm. Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of oxcarbazepine using 5-10 μg/ml (r² = 0.9984) for second order derivative area under curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. The developed methods were successfully applied to estimate the amount of oxcarbazepine in pharmaceutical formulations....
Two simple, sensitive, accurate and economical spectrophotometric methods were developed for the estimation of Trimethoprim and Sulphamethoxazole simultaneously in tablet dosage forms. First method is based on the simultaneous equations and second method is based on Q-analysis (absorbance ratio method). Trimethoprim and Sulphamethoxazole show absorbance maxima at 256 nm and 254 nm in Methanol respectively. The linearity was obtained in the concentration range of 2-10 µg/ml for Trimethorpim and 2-10 µg/ml for Sulphamethoxazole. In the first method, the concentrations of the drugs were determined by using simultaneous equations; and in the second method, the concentrations of the drugs were determined by using ratio of absorbance at isoabsorptive point and at the max of the one drug. The results of analysis have been validated statistically and by recovery studies....
A forced degradation study of acebutolol hydrochloride in bulk and injectable form was conducted under hydrolytic condition. The study was conducted as per available guidelines and main references. Stability indicating RP- HPLC method has been reported for analysis of acebutolol hydrochloride. Purposeful degradation can be a useful tool to predict the stability of a drug substance or a drug product with effects on purity, potency and safety. Acebutolol hydrochloride is a cardio-selective beta-blocker used in the management of hypertension, angina pectoris and cardiac arrhythmias. Extensive degradation was observed under hydrolytic condition using acid, alkali and oxidative hydrolysis. The degraded products were analysed by standard comparison method of UV spectrophotometry. Forced degradation was performed in bulk drug and tablet dosage form using 1 N sodium hydroxide, 0.1 N hydrochloric acid and 6% H2O2. 25.46% and 23.54% degradation was observed after 90 mins using alkali hydrolysis in 0.1 N sodium hydroxide, 20.56% and 20.68% degradation was observed at the end of 90 minutes in 0.1 hydrochloric acid, 23.68% and 23.51% degradation was observed after 90 mins using 6% H2O2 in bulk content and sample content respectively. It was concluded that acebutolol hydrochloride was found unstable under acid, alkali and oxidative hydrolysis conditions....
A convenient, simple, specific, accurate, precise, rapid, inexpensive isocratic reversed phase-high performance liquid chromatography (RP-HPLC) method was developed and validated for the quantitative determination of mebeverine HCl in pharmaceutical tablet dosage forms. RP-HPLC method was developed by using welchrom C18 Column (4.6 X 250 mm, 5µm), Shimadzu LC-20AT prominence liquid chromatograph. The mobile phase composed of 10 mM phosphate buffer (pH-3.0, adjusted with triethylamine): acetonitrile (50:50 v/v). The flow rate was set to 1.0 ml.min-1 with the responses measured at 261 nm using shimadzu SPD-20A Prominence UV-Vis detector. The retention time of mebeverine HCl was found to be 4.683 minutes. Linearity was established for mebeverine HCl in the range of 2-10 µg.ml-1 with correlation coefficient 0.9999. The LOD and the LOQ were found to be 0.0653 μg.ml-1 and 0.1980 μg.ml-1 respectively. The amount of mebeverine HCl present in the formulation was found to be 99.90%. The validation of the developed method was carried out for specificity, linearity, precision, accuracy, robustness, limit of detection, limit of quantitation. The developed method can be used for routine quality control analysis of mebeverine HCl in pharmaceutical tablet dosage form....
A rapid, specific, accurate, precise and robust reverse phase high performance liquid chromatographic method was developed for the estimation of paliperidone in tablet dosage form. The method was carried out on bondapack column (3.9 mm x 300 mm) column. Mobile phase composed of methanol and buffer (0.5% ammonium dihydrogen phosphate adjusted to pH 3 by using orthophosphoric acid) in the ratio of 75:25v/v, used at a flow rate of 1 ml/min. Detection was carried out at 235 nm. Paliperidone was eluted at the retention time of 3.4±0.1 min. The Linearity was found to be in the range 1 – 1000 µg/ml (r2 = 0.998). Both precision and accuracy were determined and as the % RSD testifies, the method was accurate and precise. The results obtained in this study proved that the developed method was reliable, precise, robust and accurate....
A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of itopride hydrochloride and lansoprazole in synthetic mixture using Simultaneous equation method. The absorbance was measured at 258.00 nm for itopride hydrochloride and 284.00 nm for lansoprazole and calibration curves were plotted as absorbance versus concentration, respectively. The method was found to be linear (r2>0.9985) in the range of 5-25 μg/ml for itopride hydrochloride at 258.00 nm. The linear correlation was obtained (r2>0.9985) in the range of 5-25 μg/ml for lansoprazole at 285.00 nm. The limit of determination (LOD) was 0.233μg/ml and 0.706μg/ml for itopride hydrochloride and lansoprazole respectively. The limit of quantification (LOQ) was 0.162 μg/ml and 0.491 μg/ml for itopride hydrochloride and lansoprazole respectively. The accuracy of these methodswas evaluated by recovery studies and good recovery result was obtained greater than 99%.The method was successfully applied for simultaneous determination of itopride hydrochloride and lansoprazole in binary mixture....
A simple, sensitive, precise and accurate new uv-visible spectrophotometric method has been developed for estimation of ibuprofen and carisoprodol in synthetic mixture. The method was based on employing simultaneous equation method for analysis of both drugs. The proposed method employs the derivatization of carisoprodol by reagent 1,2-Naphthoquinone-4-sulfonic acid sodium salt in the presence of borate buffer at optimize condition. Linearity range was observed in the concentration range of 40-90 μg/ml for carisoprodol and 80-180 μg/ml for Ibuprofen. The method involved simultaneous analysis based on the measurement of absorbance at two wavelengths, i.e, λmax of carisoprodol (251.60 nm) and λmax of ibuprofen (265.0 nm). The method was validated statistically and recovery study was performed to confirm the accuracy of the method. The recovery was found to be 98.95-99.25 and 100.27-100.58 for carisoprodol and of ibuprofen respectively....
Rapid RP-HPLC method was developed for simultaneous estimation of isoniazid, metformin hydrochloride and glimepiride. Analysis was done in synthetic mixtureof isoniazid, metformin and glimepiride. Stationary phase as Hibar® 250-4.6 HPLC column Purosphen® STAR RP-18. Mobile phase methanol:water at the ratio 70:30 v/v was used. Flow rate was 0.8 ml/min, wavelength was set as 234 nm and the volume of inject was 100 ppm. The retention time of the isoniazid, metformin HCl and glimepiride was found to be 2.88, 2.41 and 4.66 minutes respectively....
Bhasmas are unique ayurvedic metallic preparations with herbal juices/fruits widely used for the treatment of variety of chronic ailments. Standardization of bhasma is very necessary to confirm its identity and to determine its quality and purity. It will also make sure the safety effectiveness and the acceptability of the formulation. But the most important challenge faced by these formulations is lack of complete standardization. An attempt has been made to summarize the ancient and the advanced methods available for standardization of bhasma such as verna, varitara, rekhapurnatatvam, niruttha, AAS, FTIR, SEM, NPST, etc....
An accurate, precise, sensitive and relatively simple RP-HPLC method was developed for the simultaneous estimation of and brimonidine tartrate (BRT) and timolol maleate (TM) in pure form as well as in pharmaceutical formulation. The chromatographic separation was achieved on Spheri-5 RP-18 (25 cm×4.6 mm, 5 µ), perkin elmer: brownlee columns with a mobile phase combination of Acetonitrile: Buffer (0.1% triethylamine pH adjusted to 2.5 using o-phosphoric acid) (40:60 %v/v) at a flow rate of 1ml/min. UV Detection was carried out at 309 nm. Retention time for BRT was 3.2 min and that of TM was 4.1 min. The method was found to be linear in the range of 2-12 µg/ml for BRT and 5-30 µg/ml for TM. The LOD values for BRT and TM were found to be 0.59 µg/ml and 1.63 µg/ml respectively. The LOQ values were found to be 1.96 µg/ml and 4.5 µg/ml respectively for BRT and TM. The method was validated for accuracy, precision (intra-day and inter-day precision studies) and robustness as per the ICH guidelines and the %RSD values were found within the acceptable criteria (<2%)....
Simple, fast and reliable spectrophotometric methods were developed for determination of carvedilolin bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in double Methanol. The quantitative determination of the drug was carried out using the zero order derivative values measured at 284 nm and the area under the curve method values measured at 276-294 nm (n = 2).Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of carvedilolusing 2-10 μg/ml (r² = 0.999 and r² = 0.997) for zero order and area under the curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. Developed spectrophotometric methods in this study are simple, accurate, precise and sensitive to assay of carvedilolin tablets....
Simple, fast and reliable spectrophotometric methods were developed for determination of Cefadroxil in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in Distilled Water. The quantitative determination of the drug was carried out using the zero order derivative values measured at 264 nm and the area under the curve method values measured at 260-266 nm (n=2). Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Cefadroxil using 5-25 μg/ml (r²=0.9991 and r²=0.9993) for zero order and area under the curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. Developed spectrophotometric methods in this study are simple, accurate, precise and sensitive to assay of Cefadroxil in tablets....
Simple, fast and reliable spectrophotometric methods were developed for determination of cetrizine hydrochloride in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in distilled water. The quantitative determination of the drug was carried out using the zero order derivative values measured at 234 nm and the area under the curve method values measured at 226-234 nm (n = 2). Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of cetrizine hydrochloride using 2-10 μg/ml (r² = 0.9989 and r² = 0.9937) for zero order and area under the curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. Developed spectrophotometric methods in this study are simple, accurate, precise and sensitive to assay of cetrizine hydrochloride in tablets....
Simple, fast and reliable spectrophotometric methods were developed for determination of Ibuprofen in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in Methanol. The quantitative determination of the drug was carried out using the zero order derivative values measured at 222 nm and the area under the curve method values measured at 218-226 nm (n=2). Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Ibuprofen using 5-25μg/ml (r²=0.999 and r²=0.999) for zero order and area under the curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. Developed spectrophotometric methods in this study are simple, accurate, precise and sensitive to assay of Ibuprofen in tablets....
Simple, fast and reliable spectrophotometric methods were developed for determination of lisinopril dihydrate in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in double distilled water. The quantitative determination of the drug was carried out using the zero order derivative values measured at 212 nm and the area under the curve method values measured at 202-216 nm (n = 2). Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of lisinopril dihydrate using 5-25 μg/ml (r² = 0.973 and r² = 0.985) for zero order and area under the curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. Developed spectrophotometric methods in this study are simple, accurate, precise and sensitive to assay of lisinopril dihydrate in tablets....
Simple, fast and reliable spectrophotometric methods were developed for determination of ondansetron hydrochloride in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in distilled water. The quantitative determination of the drug was carried out using the zero order derivative values measured at 252 nm and the area under the curve method values measured at 250-254 nm (n = 2). Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of ondansetron hydrochloride using 2-10 μg/ml (r² = 0.9977 and r² = 0.9976) for zero order and area under the curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. Developed spectrophotometric methods in this study are simple, accurate, precise and sensitive to assay of ondansetron hydrochloride in tablets....
Simple, fast and reliable spectrophotometric methods were developed for determination of Prednisolone in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in Methanol. The quantitative determination of the drug was carried out using the zero order derivative values measured at 248 nm and the area under the curve method values measured at 244-252 nm (n=2). Calibration graphs constructed at their wavelength of determination were linear in the concentration range of Prednisolone using 2-10μg/ml (r²=0.9986 and r²=0.9963) for zero order and area under the curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. Developed spectrophotometric methods in this study are simple, accurate, precise and sensitive to assay of Prednisolone in tablets....
Simple, fast and reliable spectrophotometric methods were developed for determination of ranitidine in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in methanol. The quantitative determination of the drug was carried out using the zero order derivative values measured at 314 nm and the area under the curve method values measured at 306-318 nm (n = 2). Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of ranitidine using 2-10 μg/ml (r² = 0.997 and r² = 0.998) for zero order and area under the curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. Developed spectrophotometric methods in this study are simple, accurate, precise and sensitive to assay of ranitidine in tablets....
Simple, fast and reliable spectrophotometric methods were developed for determination of Trimethoprim in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in Methanol. The quantitative determination of the drug was carried out using the zero order derivative values measured at 256 nm and the area under the curve method values measured at 252-260 nm (n=2). Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Trimethoprim using 2-10μg/ml (r²=0.9938 and r²=0.9981) for zero order and area under the curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. Developed spectrophotometric methods in this study are simple, accurate, precise and sensitive to assay of Trimethoprim in tablets....
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