Current Issue : July-September Volume : 2016 Issue Number : 3 Articles : 28 Articles
Simple, rapid, sensitive, economic and reproducible methods were developed for the estimation of Atazanavir and Cobicistat in synthetic mixture. The developed method were validated in accordance with ICH Q2 guidelines. Method A is first order derivative spectroscopic method was performed at detection wavelength 319.85 nm for atazanavir and 248.25 nm for cobicistat. Method B is dual wavelength spectroscopic method was performed at detection wavelength 226.30 nm and 247.15 nm for atazanavir and 238.46 nm and 258.81 nm for cobicistat. Methanol was used as solvent in the both methods. In both the methods drugs shows linearity in the concentration range of 5-30 µg/ml for atazanavir and 15-90 µg/ml for cobicistat. Results of analysis for the both the methods were validated statistically and by recovery studies. The developed methods could be used for routine analysis of atazanavir and cobicistat in synthetic mixture due to simplicity, ease of operation and short time required for quantification....
A simple, efficient, precise and accurate spectroscopic method has been developed and validated for quantitative estimation of esomeprazole in bulk and tablet dosage form. Esomeprazole standard solution was scanned in the UV rang (400-200 nm) in a 1 cm quartz cell in a double beam UV spectrophotometer. The max of esomeprazole was 300.6 nm. The method obeys beers law in the concentration range from 2.5-20 μg/ml. The correlation coefficient was found to be 0.9995 and regression of the curve was found y = 0.0336x + 0.0819 with excellent recovery 99-101%. Limit of detection and limit of quantitation were found to be 0.017021 mg/ml and 0.051579 mg/ml respectively. The method was validated for several parameters like accuracy, precision as per ICH guidelines. Value of % RSD and % recovery was found satisfactory, hence that the proposed method is precise, accurate and economical hence can be used for routine analysis....
Public hazard and health concerned with respect to sodium saccharin as artificial sweetener in various marketed routine products provoked us to perform present study, where a multitude of marketed products including mouthwash, toothpaste, antacid sachets, pan masala, supari, pan flavorings substances and sugar free cough syrup were collected from local market and analyzed. Analyzed samples were compared to maximum permissible limits for sodium saccharin content as approved by “fssai” for various products. This work represents chloroform based extraction method in marketed products followed by dissolving extract residue in 1% Na2CO3 and performing further dilution for UV analysis, similarly extract residue was dissolved in mobile phase (Acetonitrile: Phosphate buffer pH 3.5, 40:60% v/v) and analyzed by RP-HPLC after suitable dilution. Saccharin content was estimated using standard calibration curve of sodium saccharin, linearity range was found to be 10-50 μg/ml for both UV and HPLC method. Results showed many of samples to be falling out of fssai maximum permissible limit. Few sample showed Saccharin content without any label warning. The pharmacological study on sodium saccharin shows health hazard on long term intake hence marketed products had to be analyzed periodically for well being of individuals consuming sodium saccharin....
HPLC technique was applied to quantitatively analyze ketoconazole in nanostructured lipid carrier. The chromatographic method was performed by using an isocratic system. The mobile phase was composed of acetonitrile-methanol in the ratio of (70:30%) with a flow rate of 1 ml/min; the detection wavelength was at 295 nm. The standard calibration curve was linear over the concentration range of 50-300 μg/ml with R2 (0.997) and ketoconazole was successfully separated with good linearity (the regression equation is Y = 49968x+10872 (R² = 0.997). The limit of detection (LOD) and limit of quantitation (LOQ) obtained for ketoconazole were 0.001040664 μg/ml and 0.003153526 μg/ml. The HPLC technique was proper for quality control of ketoconazole in nanostructured lipid carrier dispersion....
A reverse phase liquid chromatography (LC) method was developed and validated for simultaneous estimation of pilocarpine nitrate and chlorbutanol in their gel dosage form. The isocratic LC analysis was performed on phenomenex gemini ODS C18 column (200 mm x 4.6 mm, 5 μ) using mobile phase composed of water (pH 4): methanol (50:50, v/v) at a flow rate of 1.0 ml/min. Quantitation was performed using UV detector at 260 nm. The retention times were found to be 3.273 min for pilocarpine nitrate and 4.807 min for chlorbutanol. The analytical method was validated according to ICH guidelines. The linearity was observed in the range of 20-60 μg/ml and 2.5-7.5 μg/ml with correlation coefficient, r=0.9998 and 0.998 for pilocarpine nitrate and chlorbutanol respectively. The accuracy (%recovery) was found to be 99.25 – 101.41% for pilocarpine nitrate and 98.92 – 101.505 % for chlorbutanol. The relative standard deviation values for repeatability and intermediate precision studies were less than 2%. The method was successfully applied for market sample analysis and mean percentage assay values were 99.34±0.796 and 99.527±1.083 for pilocarpine nitrate and chlorbutanol respectively....
The present work describes two simple, precise and economical UV methods have been developed for the estimation of esomeprazole magnesium trihydrate in bulk and pharmaceutical dosage form. Distilled water was selected as common solvent for estimation of esomeprazole. First order derivative spectra showed sharp peak at 300.6 nm and area under curve method involves the calculation of integrated value of absorbance with respect to the wavelength between two selected wavelength 290-310 nm respectively. The linearity range was found to be 3-21 μg/ml in distilled water for both methods. The regression equation were found to be y = -0.0001x - 0.0002 (r2 = 0.9986) for first order derivative method and y = 0.103x + 0.1355 (r2 = 0.9989) for AUC method. Intraday and interday precision, % RSD for esomeprazole was found to be satisfactory. The methods were validated by following the analytical performance parameters suggested by the International Conference on Harmonization (ICH). All validation parameters were within the acceptable range. The developed methods were successfully applied to estimate the amount. As economical solvent was used, these methods were used for routine analysis of esomeprazole in bulk and pharmaceutical formulation....
A simple, rapid, accurate and precise first order derivative spectrophotometric method has been developed for simultaneous estimation of candesartan cilexetil (CAN) and pioglitazone hydrochloride (PIO) in their combined pharmaceutical dosage form. This method utilizes methanol as a solvent. Zero crossing point (ZCP) of candesartan cilexetil and pioglitazone hydrochloride was found to be 242.00 nm and 327.60 nm respectively. Hence, estimation of candesartan cilexetil and pioglitazone hydrochloride was done at 327.60 nm and 242.00 nm respectively. Linearity was observed in the concentration range of 10-50 μg/ml for candesartan cilexetil (r2=0.9995) and 20-100 μg/ml for (r2=0.9994). The results of analysis have been validated statistically and by recovery studies. Developed method was applied to pharmaceutical dosage form. The results were found to be within acceptance criteria according to ICH guideline....
A simple, precise, accurate, reproducible and robust HPLC method was developed for the estimation of atazanavir and cobicistat in synthetic mixture. The method was validated as per ICH guidelines. Analysis of the drug was performed on Phenomenex Luna C18 (250 mm × 4.6 mm, 5 µ) column, in an isocratic mode employing pH 4.5 phosphate buffer: Acetonitrile (60:40 % v/v) as the mobile phase. UV-Visible detector at 238 nm was found to be suitable for detection. The method shows good peak shape, minimal tailing, with retention time 2.69 min for atazanavir and 4.79 min for cobicistat. Linearity was observed in the range of 15-45 µg/ml (r2 = 0.999) for atazanavir and 7.5-22.5 µg/ml (r2 = 0.999) for cobicistat. Recovery values were found to be 99.75 - 101.94 % and 99.33 – 101.88 % for atazanavir and cobicistat respectively. LOD of the method were found to be 5.06 µg/ml for atazanavir and 2.80 µg/ml for cobicistat. LOQ of the method were found to be 15.35 µg/ml and 8.50 µg/ml for atazanavir and cobicistat respectively. The statistical parameters were found within range....
A simple, rapid, economic, sensitive and precise RP-HPLC method has been developed for the simultaneous estimation of dicyclomine and tramadol in capsule dosage form. An isocratic separation was carried out using C18 column (250 × 4.6 mm, 5 μm) and acetonitrile : 0.02M KH2PO4 Buffer pH 6.0 (±0.05) adjusted with 0.1M NaOH (70:30 % v/v) as mobile phase with quantification carried out at a wavelength of 215 nm. The retention time of the dicyclomine and tramadol was 7.77 and 2.89 minutes, respectively with theoretical plate count and asymmetry as per the ICH limits. The % assay of dicyclomine and tramadol were 99.99% and 101.07%. The flow rate was found to be 1 ml/min. The linear regression analysis data for the calibration plots showed a good linear relationship for dicyclomine and tramadol over a concentration range of 5-30 μg/ml and 25-150 μg/ml with correlation co-efficient of 0.9994 for dicyclomine and 0.9987 for tramadol. The limits of detection and quantification were found to be 0.07, 0.50 and 0.23, 1.51 μg/ml respectively....
A reverse phase liquid chromatography (LC) method was developed and validated for simultaneous estimation of mupirocin and beclomethasone dipropionate in ointment Formulation. The isocratic LC analysis was performed on Phenomenex Gemini ODS C18 column (200 mm x 4.6 mm, 5μ) using mobile phase composed of Methanol: Buffer pH 4 (65:35, v/v) at a flow rate of 1.0 ml/min. Quantitation was performed using UV detector at 215 nm. The retention times were found to be 3.36 min for mupirocin and 6.02 min for beclomethasone dipropionate. The analytical method was validated according to ICH guidelines. The linearity was observed in the range of 40-120 and 0.5-1.5 μg/ml with correlation coefficient, r=0.996 and 0.997 for mupirocin and beclomethasone dipropionate respectively. The accuracy (%recovery) was found to be 99.45-99.86% for mupirocin and 100.10-100.39% for beclomethasone dipropionate. The relative standard deviation values for repeatability and intermediate precision studies were less than 2%. The method was successfully applied for market sample analysis and mean percentage assay values were 98.37±0.49 and 97.19±1.379 for mupirocin and beclomethasone dipropionate respectively. The present method is precise and accurate and can be used for the routine estimation of mupirocin and beclomethasone dipropionate in ointment formulation....
A simple, precise, accurate, reproducible and economical reverse phase liquid chromatography method was developed and validated for the quantitative simultaneous estimation of lamivudine and tenofovir disoproxil fumarate in bulk and tablet dosage form. Estimation of drugs in this combination was done with a C18 column Kromasil 100-5C18 column (250 mm x 4.6 mm) using mobile phase of composition Acetonitrile and phosphate buffer (60:40 v/v, pH 6.0). The flow rate was 1 ml/min and the effluents were monitored at 266 nm. The retention time of lamivudine and tenofovir disoproxil fumarate was 3.3 min and 6.25 min respectively. The method was found to be linear over a concentration range of 20-100 g/ml for both lamivudine and tenofovir disoproxil fumarate. The established method proved as reproducible one with a %RSD value of less than 2 and having the robustness and accuracy within the specified limits. Assay of marketed formulation was determined and found with 98.1% and 97.6% for lamivudine and tenofovir disoproxil fumarate respectively. The method was validated according to the guidelines of International Conference on Harmonization (ICH) and was successfully employed in the estimation of commercial formulations. This liquid chromatographic method can be applied for the qualitative and quantitative determination of selected drugs by the modern chemist....
A simple, accurate, precise and sensitive UV spectrophotometric method was developed for the determination of ledipasvir in bulk form. The optimum conditions for the analysis of the drug were established. Ledipasvir was subjected to stress degradation under different conditions recommended by the International Conference on Harmonization (ICH). The samples so generated were used for degradation studies using the developed method. The solvent used was methanol and the wavelength corresponding to maximum absorbance of the drug was found at 333 nm. Beers law was observed in the concentration range of 2-12 μg/ml with correlation coefficient 0.999. The linear regression equation obtained by least square regression method were y=0.096X-0.005, where y is the absorbance and x is the concentration of the pure drug solution. The limit of detection (LOD) and limit of quantitation (LOQ) for estimation of ledipasvir were 0.110818 μg/ml and 0.335812 μg/ml respectively. The method was validated for several parameters like accuracy, precision as per ICH guidelines. The values of relative standard deviation and % recovery were found to be satisfactory, indicating that the proposed method is precise and accurate and hence can be used for the routine analysis of ledipasvir in bulk form....
A simple, rapid, economical, precise and accurate stability indicating RP-HPLC method for simultaneous estimation of rosiglitazone and glimepiride in their combined dosage form has been developed. The separation was achieved by LC-20 AT C18 (150 mm×4.6 mm×5 μm) column and Water (pH 4): Methanol : Triethylamine (25:75:0.05) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 235 nm. Retention time of rosiglitazone and glimepiride were found to be 3.253 min and 6.613 min, respectively. The method has been validated for linearity, accuracy and precision. Linearity observed for rosiglitazone 20-60 μg/ml and for glimepiride 5-15 μg/ml. The percentage recoveries obtained for rosiglitazone and glimepiride were found to be in range of 99.613 -101.017 and 99.133 -100.437 respectively. Developed method was found to be accurate, precise and rapid for simultaneous estimation of rosiglitazone and glimepiride in their combined dosage form....
The aim of the present was to develop and validate uv spectrophotometric method for analysis of antidiabetic drug Bougainvillea spectabilis (D-pinitol). Bougainvillea spectabilis is a most abundantly found plant having an insulin mimicking agent. A simple, accurate, sensitive, precise and economical spectroscopic method has been developed and validated for the determination of this drug. The solvent used was phosphate buffer (6.8) (for solubility purpose) to determine the D-pinitol. The wavelength corresponding to maximum absorbance of the D-pinitol was found at 205 nm. The method obeys Beer’s law in the concentration range of 50-450 μg/ml and exhibited good correlation coefficient (R2=0.9993) and the regression of the curve was found y=0.1379x-0.2467 with excellent mean recovery (98-100%). The limit of detection (LOD) and limit of quantitation (LOQ) were found to be 0.69169 μg/ml and 2.03544 μg/ml respectively. The method was validated for several parameters like accuracy, precision as per ICH guidelines. The values of relative standard deviation and percentage recovery were found to be satisfactory; indicating that the proposed method is precise, accurate and economical hence can be used for the routine analysis....
A simple, efficient, precise and accurate spectroscopic method has been developed and validated for quantitative estimation of cycloserine in bulk and pharmaceutical dosage form. Cycloserine standard solution was scanned in the UV rang (400-200 nm) in a 1 cm quartz cell in a double beam UV spectrophotometer. The max of cycloserine was 216.6 nm. The method obeys beers law in the concentration range from 5-25 μg/ml. The correlation coefficient was found to be 0.9996 and regression of the curve was found y = 0.0302x + 0.0128 with excellent recovery 99-101%. Limit of detection and limit of quantitation were found to be 0.24541 mg/ml and 0.79894 mg/ml respectively. The method was validated for several parameters like accuracy, precision as per ICH guidelines. Value of % RSD and % recovery was found satisfactory, hence that the proposed method is precise, accurate and economical hence can be routine analysis....
A simple, efficient, precise and accurate spectroscopic method has been developed and validated for quantitative estimation of terizidone in bulk and pharmaceutical dosage form. Terizidone standard solution was scanned in the UV range (400-200 nm) in a 1 cm quartz cell in a double beam UV spectrophotometer. The max of terizidone was 273.0 nm. The method obeys beers law in the concentration range from 4-12 μg/ml. The correlation coefficient was found to be 0.9994 and regression of the curve was found y=0.651x + 0.0258 with excellent recovery 99-101%. Limit of detection and limit of quantitation were found to be 0.09714 mg/ml and 0.29437 mg/ml respectively. The method was validated for several parameters like accuracy, precision as per ICH guidelines. Value of % RSD and % recovery was found satisfactory, hence the proposed method is precise, accurate and economical hence can be routine analysis....
A simple, accurate, precise stability indicting RP-HPLC method was developed and validated for estimation of prucalopride in tablet dosage form. This RP-HPLC method had shown adequate separation for prucalopride from its degradation products. The separation was achieved on an Inertsil ODS-3V C18 (250 mm × 4.6 mm i.d., 5 µm particle size) with an isocratic mixture of 10 mM potassium dihydrogen phosphate (KH2PO4) buffer (pH 2.0):methanol (50:50). The mobile phase at a flow rate of 1.5 ml/min, Injection volume 50 µl and wavelength of detection was kept at 225 nm. The retention time for prucalopride was 4.736 min. The linearity of the proposed method was investigated in the range of 50-150 µg/ml for prucalopride. Correlation coefficient was 0.999. Forced degradation study was carried out on tablet dosage form as per ICH guideline and it was exposed to hydrolysis (acid and base hydrolysis), oxidative and thermal conditions to apply stress. Proposed method was validated as per ICH guidelines for specificity, linearity, accuracy, precision and robustness for estimation of prucalopride in commercially available pharmaceutical dosage form and results were found to be satisfactory. The developed and validated RP-HPLC method can be used successfully for marketed formulations....
The present study provides a high degree of assurance that a specific process for manufacturing of nifedipine extended release tablets will consistently produce a product meeting its predetermined specifications and quality attributes. It mainly involves the steps to be followed to evaluate and qualify the acceptability of manufacturing process of nifedipine extended release tablets. The process is limited to the three batches manufactured of specific batch size with specified equipments and control parameters for tablets. It involves all parameters related to the each step were evaluated by respective standard test involved in the manufacturing. Sampling, testing plan and acceptance criteria for each step were monitored. The analytical results of all stages were found to be within acceptable limit. Other test related to compression such as hardness, thickness, disintegration and dissolution for all three batches were found within acceptable limit....
This article presents risk analysis performed on manufacturing process of dry powder injection. Failure Mode and Effects Analysis (FMEA) is a procedure which is performed after a failure mode effects analysis to classify each potential failure effect according to its severity and probability of occurrence. FMEA is a systematic method for evaluating a process to identify where and how it might fail and to assess the relative impact of different failures, in order to identify the part of the process that are most in need of change. Each failure mode was ranked on estimated frequency of occurrence (O), probability that the failure would remain undetected later in the process (D) and severity (S). Human errors turned out to be the most common cause of failure modes. As part of a risk assessment, severity and probability need to be evaluated to establish the risk class. This is the first step of the risk assessment. In the second stage, the risk class is plotted against the possibility of the fault being detected before harm occurs; thus the risk priority is determined. FMEA is particularly useful in evaluating a new process prior to implementation and in assessing the impact of a proposed change to an existing process which depends on product and process understanding....
A reverse phase liquid chromatography (LC) method was developed and validated for simultaneous estimation of meclizine and folic acid in tablet dosage form. The isocratic LC analysis was performed on phenomenex gemini ODS C18 column (200 mm x 4.6 mm, 5μ) using mobile phase composed of buffer:methanol pH 3.5 adjusted by phosphoric acid (65:30, v/v) at a flow rate of 1.0 ml/min. Quantitation was performed using UV detector at 210 nm. The retention times were found to be 3.760 min for meclizine and 6.133 min for folic acid. The analytical method was validated according to ICH guidelines. The linearity was observed in the range of 12.5-37.5 and 1.25-3.75 μg/ml with correlation coefficient, r=0.997 and 0.998 for meclizine and folic acid respectively. The accuracy (%recovery) was found to be 98.73 - 100.47 % for meclizine and 98.83 – 101.07 % for folic acid. The relative standard deviation values for repeatability and intermediate precision studies were less than 2%. The method was successfully applied for market sample analysis and mean percentage assay values were 97.97 and 100.24 for meclizine and folic acid respectively. The present method is precise and accurate and can be used for the routine estimation of meclizine and folic acid in tablet dosage form....
A reversed-phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of esomeprazole in bulk and tablet dosage forms. The separation was achieved on stainless steel Purospher® STAR Hibar® C18 analytical column (250 mm × 4.6 mm i.d., 5.0 μm) using acetonitrile and phosphate buffer (0.05 M) in the ratio 50:50 v/v as mobile phase and at a flow rate of 1.2 ml/min. Detection was carried out using a UV detector at 301 nm. The method was validated for accuracy, precision, linearity, LOD, LOQ and robustness. Validation studies demonstrated that this HPLC method is simple, specific, rapid, reliable and reproducible. The standard curve was linear over the concentration range of 3-21 μg/ml with R2 close to one (0.999). The limit of detection (LOD) and limit of Quantitation (LOQ) obtained for esomeprazole were 0.000065 μg/ml and 0.000197 μg/ml, respectively. The developed and validated method was successfully applied for the quantitative analysis of Nexpro® tablets. This method can be used as more convenient and efficient option for the analysis of esomeprazole to establish the quality of the drug substance during routine analysis with consistent and reproducible results....
A simple, selective, rapid, precise and economical reverse phase high-pressure liquid chromatographic method has been developed for the estimation of 4-(4-(4-(Hydroxydiphenylmethyl)-1-Piperidinyl)-1-Oxobutyl)-α, α-dimethyl benzene acetic acid methyl ester. The method was carried out on a Luna Phenyl Hexyl (250 × 4.6 mm, 5 μm) column, with a mobile phase consisting of Buffer: Acetonitrile pH 2.0 (50:50 v/v) at a flow rate of 1.5 ml/min. The retention time of 4-(4-(4-(Hydroxydiphenylmethyl)-1-Piperidinyl)-1-Oxobutyl)-α, α-dimethyl benzene acetic acid methyl ester was 6.25 min. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantitation. The proposed method can be used for estimation of 4-(4-(4-(Hydroxydiphenylmethyl)-1-Piperidinyl)-1-Oxobutyl)-α, α-dimethyl benzene acetic acid methyl ester for routine analysis at laboratory....
A simple precise and accurate RP-HPLC method has been developed for estimation of ornidazole and miconazole in tablet dosage form. Ornidazole and miconazole chromatographic separation was carried out on Hiber Lichrospher® 100, RP-18e (5 µm), Merck Ltd. India, 250 mm L × 4.6 mm I.D in size, using mobile phase Acetonitrile: methanol (80:20 % v/v) and detected at 219 nm. Validation of developed method was performed according to ICH Q2 R1guidline. The linearity concentration range was 20 µg/ml -60 µg/ml for ORN and 4 µg/ml-12 µg/ml for MIC. The retention times of ornidazole and miconazole were found to be 3.53 min and 7.41 min respectively. The limit of quantification (LOQ) for ornidazole and miconazole were found to be 4.894 µg/ml and 0.898 µg/ml respectively. Then the limit of detection (LOD) for ornidazole and miconazole were found to be 1.615 µg/ml and 0.57 µg/ml. The percentage recoveries obtained for ornidazole and miconazole ranges from 98.36% - 101.52% and 98.88% - 101.50% respectively. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate which is useful for the routine determination of ornidazole and miconazole in its tablet dosage form....
The present study deals with the development of an accurate, economical and reproducible UV spectrophotometric method simultaneous estimation of lamivudine, efavirenz and zidovudine. The method employs formation and solving of simultaneous equation using 246.2, 265.8 and 269.6 nm as three analytical wavelengths. The drugs obey Beer’s law in the concentration ranges of 3-21 µg/ml. Accuracy and reproducibility of the proposed method was statistically validated by recovery studies. The method was found to be rapid, precise and accurate and can easily be employed in the laboratory for the routine estimation of drugs....
A simple, economic, selective, precise and stability indicating reverse HPLC method has been developed and validated for ampicillin and sulbactam in injection dosage form. The isocratic LC analysis was performed on Phenomenex Gemini ODS C18 column (200 mm x 4.6 mm, 5μ) using mobile phase composed of acetonitrile: buffer pH 3.5 adjusted by phosphoric acid (60:40, v/v) at a flow rate of 1.0 ml/min. Quantitation was performed using UV detector at 250 nm. The retention times were found to be 3.263 min for sulbactam and 7.147 min for ampicillin. The analytical method was validated according to ICH guidelines. The linearity was observed in the range of 10-30 and 5-15 μg/ml with correlation coefficient, r=0.995 and 0.999 for ampicillin and sulbactam respectively. The accuracy (% recovery) was found to be 98.95 - 100.30 % for ampicillin and 99.17-100.50 % for sulbactam. The relative standard deviation values for repeatability and intermediate precision studies were less than 2%. The method was successfully applied for market sample analysis and mean percentage assay values were 100.50 and 98.65 for ampicillin and sulbactam respectively. Ampicillin and sulbactam active substance was subjected to forced degradation to demonstrate the stability indicating power of the HPLC method. Acidic, basic, photolytic, thermal and oxidative degradation were used to assess the stability of the method. The drug was found to degrade in all studied conditions but the extent of degradation was different. The proposed method is rapid, cost-effective and can be used as a quality-control tool for routine quantitative analysis of ampicillin and sulbactam. The present method is precise and accurate and can be used for the routine estimation of ampicillin and sulbactam in injection dosage form....
A simple, efficient, precise and accurate spectroscopic method has been developed and validated for quantitative estimation of albendazole in bulk and tablet dosage form. Albendazole standard solution was scanned in the UV rang (600-200 nm) in a 1 cm quartz cell in a double beam UV spectrophotometer. The max of albendazole was 298 nm. The method obeys beers law in the concentration range from 5-25 μg/ml. The correlation coefficient was found to be 0.9992 and regression of the curve was found y = 0.0312x + 0.0035 with excellent recovery 99-101%. Limit of detection and limit of quantitation were found to be 0.4720107663 mg/ml and 2.0012666244 mg/ml respectively. The method was validated for several parameters like accuracy, precision as per ICH guidelines. Value of % RSD and % recovery was found satisfactory, hence that the proposed method is precise, accurate and economical hence can be used for routine analysis....
A simple, efficient, precise and accurate spectroscopic method has been developed and validated for quantitative estimation of ketoconazole in bulk and tablet dosage form. Ketoconazole standard solution was scanned in the UV rang (400-200 nm) in a 1 cm quartz cell in a double beam UV spectrophotometer. The max of ketoconazole was 277 nm. The method obeys beers law in the concentration range from 50-250 μg/ml. The correlation coefficient was found to be 0.9992 and regression of the curve was found y=0.0023x + 0.0172 with excellent recovery 99-101%. Limit of detection and limit of quantitation were found to be 0.19249 mg/ml and 0.58332 mg/ml respectively. The method was validated for several parameters like accuracy, precision as per ICH guidelines. Value of % RSD and % recovery was found satisfactory, hence that the proposed method is precise, accurate and economical hence can be used for routine analysis....
A simple, efficient, precise and accurate spectroscopic method has been developed and validated for quantitative estimation of sertaconazole nitrate in bulk and tablet dosage form. Sertaconazole nitrate standard solution was scanned in the UV rang (400-200 nm) in a 1 cm quartz cell in a double beam UV spectrophotometer. The max of sertaconazole nitrate was 260 nm. The method obeys beers law in the concentration range from 10-70 μg/ml. The correlation coefficient was found to be 0.9989 and regression of the curve was found y = 0.0116x - 0.0805 with excellent recovery 99-101%. Limit of detection and limit of quantitation were found to be 0.503928964 mg/ml and 1.527057468 mg/ml respectively. The method was validated for several parameters like accuracy, precision as per ICH guidelines. Value of % RSD and % recovery was found satisfactory, hence the proposed method is precise, accurate and economical hence can be used for routine analysis....
Loading....