Current Issue : April-June Volume : 2017 Issue Number : 2 Articles : 11 Articles
Nelfinavir (NFV) is an antiretroviral drug used in the treatment of the human immunodeficiency virus. NFV is available alone in dosage form as well as multicomponent formulation with various antiretroviral drugs like ritonavir, saquinavir, darunavir, atazanavir, nerverapine and lopinavir for the systematic management of HIV. The present review explores to assess the various approaches for analysis of NFV in bulk drug as well as formulated products. This review represents the compilation and discussion of about more than 25 analytical methods which includes HPLC, LCMS, HPTLC, Capillary electrophoresis, electrochemical and UV Spectrophotometry methods implemented for investigation of NFV in biological matrices bulk samples and in different dosage formulations....
A sensitive, cost-effective, reproducible HPLC method was developed and validated for the quantitative determination of genotoxic impurity methyl 4’-bromomethyl biphenyl-2 carboxylate present in telmisartan drug substance by applying the concept of threshold of toxicological concern, a limit of 18.75 µg/g was calculated based on the maximum daily dose of the drug substance. The impurity was separated on Welchrom C18 250 x 4.6 mm, 5 µm analytical column with a mobile phase consisting of the composition of 0.1% orthophosphoric acid and acetonitrile in the ratio of 30:70 v/v at a flow rate 1.5 ml/min. The effluent was monitored by UV detection at 258 nm with column temperature maintained at 40°C and the injection volume 30 μl. Validation activity was planned and completed based on the ICH guideline. The LOD and LOQ value were found to be 1.86 µg/g and 5.63 µg/g and accuracy results were well in the range 98.34 to 103.46%. The linearity curve showed the correlation coefficient of 0.999 and method very sensitive....
Gliclazide, [1-(1-azabicyclo (3, 3, 0) octyl)-3-(p-tolylsulphonylurea)] is used in the treatment of diabetes. Six simple, specific, sensitive, rapid and economical UV-Spectrophotometry methods have been established for the determination of gliclazide in bulk and in pharmaceutical formulation. All these UV-spectrophotometry methods have been established using zero order, first order and second order derivative technique by taking into consideration of amplitude and area under curve of the spectrum. In all six methods, gliclazide obeyed linearity in the concentration range of 3 - 21 μg/ml with correlation coefficient (r2 > 0.999). The % amounts of drug quantified in the developed methods were found to be good agreement with label claimed in tablet formulation. All the methods were validated as per International conference on Harmonization (ICH) guidelines. All these proposed methods were proved to be linear, accurate, precise and rugged and also adequately sensitive....
For estimation of diclofenac sodium in pharmaceutical dosage form, a simple, accurate and precise area under curve spectrophotometric method was developed. “The area under two points on the mixture spectra is directly proportional to the concentration of the component of interest” is the AUC curve. The area selected for estimation of diclofenac sodium was between 266 nm to 286 nm. The method represented regression coefficient (r2 = 0.9849) at concentration rang 10-50 µg/ml. Estimation of the drugs was found up to 100 % representing the accuracy of the method. The recovery of the diclofenac sodium was found up to 100 %. Validation of the proposed method was carried out for its accuracy, precision and specificity according to ICH Q2 (R1) guidelines. The developed methods can be successfully applied in routine work for the estimation of diclofenac sodium in its pharmaceutical dosage form....
For estimation of esomeprazole magnesium dihydrate in pharmaceutical dosage form, a simple, accurate and precise area under curve spectrophotometric method was developed. “The area under two points on the mixture spectra is directly proportional to the concentration of the component of interest” is the AUC curve. The area selected for estimation of ibuprofen was between 291.40 to 311.40 nm. The method represented regression coefficient (r2=0.991) at concentration rang 5-25 μg/ml. Estimation of the drugs was found up to 100 % representing the accuracy of the method. The recovery of the esomeprazole magnesium dihydrate was found up to 100 %. Validation of the proposed method was carried out for its accuracy, precision and specificity according to ICH Q2 (R1) guidelines. The developed methods can be successfully applied in routine work for the estimation of esomeprazole magnesium dihydrate in its pharmaceutical dosage form....
For estimation of ibuprofen in pharmaceutical dosage form, a simple, accurate and precise area under curve spectrophotometric method was developed. “The area under two points on the mixture spectra is directly proportional to the concentration of the component of interest” is the AUC curve. The area selected for estimation of ibuprofen was between 222.40 to 242.40 nm. The method represented regression coefficient (r2 = 0.999) at concentration rang 5-25 μg/ml. Estimation of the drugs was found up to 100 % representing the accuracy of the method. The recovery of the ibuprofen was found up to 100 %. Validation of the proposed method was carried out for its accuracy, precision and specificity according to ICH Q2 (R1) guidelines. The developed methods can be successfully applied in routine work for the estimation of ibuprofen in its pharmaceutical dosage form....
Development of an accurate, simple and cost effective UV spectrophotometric method for estimation of lovastatin was the aim of present study. This work was based upon an area under curve method i.e. “concentration of the component of interest is directly proportional to the area under two points on the mixture spectra”. The UV spectrum between 238-258 nm was selected and the validation was carried out as per ICH guideline, Q2 (R1). This method obeyed Beer’s Lamberts law over the concentration range of 5-25 μg/ml. The value of correlation coefficient was 0.9988. The method was precise due to the satisfactory value of percent relative standard deviation for the intraday and inter-day precision. Result of the recovery studies (99.8) showed accuracy of method. Hence, developed method can be used for routine estimation of lovastatin in bulk and dosage form....
The aim of present work was to develop an accurate, simple and cost effective UV spectrophotometric method for estimation of metformin HCl. This method was based on area under curve of UV spectrum between 223-243 nm and validation as per ICH guideline Q2 (R1). The method has followed linearity in the range of 5-25 μg /ml. The value of correlation coefficient was 0.9993 satisfactory value of percent relative standard deviation for the intraday and inter-day precision indicates that method was precise. Result of the recovery studies (99.32) shows accuracy of method. The developed method can be used for routine estimation metformin HCl in bulk and dosage form....
For estimation of omeprazol in pharmaceutical dosage form, a simple, accurate and precise area under curve spectrophotometric method was developed. “The area under two points on the mixture spectra is directly proportional to the concentration of the component of interest” is the AUC curve. The area selected for estimation of omeprazol was between 283.20 to 311.60 nm. The method represented regression coefficient (r2 = 0.998) at concentration rang 5-25 μg/ml. Estimation of the drugs was found up to 100 % representing the accuracy of the method. The recovery of the omeprazol was found up to 100 %. Validation of the proposed method was carried out for its accuracy, precision and specificity according to ICH Q2 (R1) guidelines. The developed methods can be successfully applied in routine work for the estimation of omeprazol in its pharmaceutical dosage form....
For estimation of tolmetin sodium in pharmaceutical dosage form, a simple, accurate and precise area under curve spectrophotometric method was developed. “The area under two points on the mixture spectra is directly proportional to the concentration of the component of interest” is the AUC curve. The area selected for estimation of tolmetin sodium was between 257 to 277 nm. The method represented regression coefficient (r2=0.999) at concentration rang 8-40 µg/ml. Estimation of the drugs was found up to 100 % representing the accuracy of the method. The recovery of the tolmetin sodium was found up to 100 %. Validation of the proposed method was carried out for its accuracy, precision and specificity according to ICH Q2 (R1) guidelines. The developed methods can be successfully applied in routine work for the estimation of Tolmetin sodium in its pharmaceutical dosage form....
A sensitive, reproducible and rapid reverse phase high performance liquid chromatographic methods were developed and validated for the determination of fluconazole (FLZ) in presence of its degradation products in pure form and pharmaceutical formulations Grace Smart C18 RP Column (250 × 4.6 mm, 5 μm) was used with a mobile phase containing a mixture of acetonitrile:water in the ratio of (60:40). The flow rate was 0.8 ml/min and effluents were monitored at 261 nm and eluted at 3.83 min. Calibration curve was plotted with a range from 10-50 µg/ml. The method was validated for the parameters like accuracy, precision, robustness and system suitability parameters. The precision, ruggedness and robustness values were also within the prescribed limits (< 1% for system precision and < 2% for other parameters). The LOD and LOQ were found to be 0.5216 μg/ml and 1.580 μg/ml respectively....
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