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
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