TITLE

DEVELOPMENT AND VALIDATION OF RP-HPLC ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF EMTRICITABINE, RILPIVIRINE, TENOFOVIR DISOPROXIL FUMARATE AND ITS PHARMACEUTICAL DOSAGE FORMS

AUTHOR(S)
Kavitha, K. Y.; Geetha, G.; Hariprasad, R.; Venkatnarayana, R.; Subramanian, G.
PUB. DATE
January 2013
SOURCE
Pharmacie Globale;Jan2013, Vol. 4 Issue 1, p1
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
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 stability indicating RP - HPLC 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 Inertsil ODS 3V column using gradient composition of 0.02M sodium dihydrogen orthophosphaste as mobile phase A and mixture of Methanol and water in ratio of 85:15as mobile phase B at a flow rate of 1.5 ml/min with detection at 261 nm. The retention times of the emtricitabine, tenofovir disoproxil fumerate and rilpivirine were about 5.875, 8.800 and 12.020 mins respectively. The detector response is linear from 8-120µg/ml, 12-180µg/ml, 20-360µg/ml of test concentration for emtricitabine, tenofovir and rilpivirine respectively. The respective linear regression equation being Y=10175x-76883 for emtricitabine, Y=6280.8x+219800 for tenofovir disoproxil fumerate and Y=1883.5x+323060 for rilpivirine. The limit of detection and Limit of quantification was 0.06, 0.07 and 0.08 µg/ml and 0.14, 0.12 and 0.15µg/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.
ACCESSION #
87977558

 

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