DEVELOPMENT AND VALIDATION OF RP-UPLC ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF EMTRICITABINE, RILPIVIRINE, TENOFOVIR DISOPROXIL FUMARATE AND ITS PHARMACEUTICAL DOSAGE FORMS
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2013, Vol 4, Issue 1
Abstract
Developing a single analytical method for estimation of individual drug from a multidrug composition is a very challenging task. A simple, rapid, precise, and reliable simultaneous RP -UPLC method was developed for the separation and estimation of three drugs emtricitabine, rilpivirine and tenofovir in bulk drug mix and pharmaceutical dosage forms. Chromatography was carried on an aquity BEH C18 column using acetonitrile and phosphate buffer pH 3 in ratio of 55:45 as mobile phase at a flow rate of 0.35 ml/min with detection at 261 nm. The retention times of the emtricitabine, tenofovir disoproxil fumerate and rilpivirine were about 0.6, 1.05 and 2.95 minutes respectively. The detector response is linear from 12-48μg/ml and 3.2-12.80μg/ml concentration for emtricitabine, tenofovir and rilpivirine respectively. The respective linear regression equation being Y=32727.95 + 6072.57 for emtricitabine, Y=17956.31x – 1066.28 for tenofovir disoproxil fumerate and Y=28648.79x + 1739.92 for rilpivirine. The limit of detection and Limit of quantification was 0.03, 0.06 and 0.07 μg/ml and 0.08, 0.15 and 0.18μg/ml for emtricitabine, tenofovir and rilpivirine respectively. The percentage assay of emtricitabine, tenofovir disoproxil fumerate and rilpivirine were about 99.50, 100.2 and 99.46 % respectively and percentage recovery for average of five different concentrations were 99.65%, 99.62% and 100.34% respectively. The method was validated as a final verification of method development with respect to precision, linearity, accuracy, ruggedness, and robustness. The validated method was successfully applied to the commercially available pharmaceutical dosage form, yielding very good and reproducible result.
Authors and Affiliations
K. Y Kavitha , G Geetha. , R Hariprasad. , M. Kaviarasu.
Keywords
Related Articles
- EP ID EP93082
- DOI -
- Views 120
- Downloads 0
STUDIES ON ANTIASTHMATIC ACTIVITY OF AQUEOUS EXTRACT OF ROOTS OF MIMOSA PUDICA LINN
The present study designed to evaluate the antiasthmatic activity of aqueous extract of Mimosa pudica (AEMP) on in vitro and in vivo animal models. Histamine induced contraction in isolated goat tracheal chain showed th...
DAUHRDA: A CONCEPTUAL REVIEWDAUHRDA: A CONCEPTUAL REVIEW
Pregnancy is the fertilization and development of one or more offspring known as embryo or fetus in a woman uterus. An embryo is the developing offspring during the first eight weeks following conception and subsequently...
PRE-CLINICAL INVESTIGATION OF ANTI-TUSSIVE ACTIVITY OF HIBISCUS ROSA-SINENSIS ON GUINEA PIG
Ayurveda suggests that decoction of leaves of Hibiscus rosa-sinensis could be beneficial to reduce cough. Codeine and other synthetic antitussive agents shows number of side-effects and thus to find better and safer alte...
ESTHETICS IN PRIMARY TEETH
Dental esthetics is an integral part of facial esthetics. Esthetic problems in childhood and adolescence can have a significant effect on psychosocial development and interaction with peers. Esthetic restoration of prima...
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CARBIDOPA, LEVODOPA AND ENTACAPONE IN ITS BULK AND TABLET DOSAGE FORM BY UPLC
The study was conducted with the purpose to method develop and validate a Ultra Performance Liquid Chromatography method UV detector to determine Levodopa, Carbidopa and Entacapone content in table preparation using MeOH...