Abstract

HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE IN PHARMACEUTICAL DOSAGE FORM

Manisha C. Kotadiya and Bhakti Shah*

ABSTRACT

Objectives: In this study a simple, Precise and rapid RP-HPLC method for the simultaneous estimation of Emtricitabine and Tenofovir disoproxil fumarate in Pharmaceutical dosage form was developed. Methods: HPLC Chromatography was carried out on phenomenex Luna C18 (4.6 mm LD x 250 mm, 5μm) column using a mixture of water 25: Acetonitrile 75 (25:75) as the mobile phase at a flow rate of 1.2ml/min, the detection was carried out at 210 nm and 230nm respectively for Metformin hydrochloride and Evogliptin tartrate. The Validation of assay method was done on sensitivity, linearity, accuracy, selectivity, precision, robustness and specificity. Results: The retention time of the Metformin hydrochloride and Evogliptin tartrate was 2.009 and 2.956 min respectively. The method procedure linear responses of Metformin hydrochloride and Evogliptin tartrate was found to be 1 and 0.997 respectively. The percent relative standard deviation for intraday variation/precision, interday variation/precision, intermediate precision/ruggedness and robustness were lower than 2%. Conclusion: The proposed method showed excellent linearity, accuracy, precision, specificity, robustness, LOD, LOQ, and system suitability results within the acceptance criteria.

Keywords: Antiviral drugs, HBV polymerase, HIV-1, nucleoside reverse transcriptase inhibitor, RP-HPLC Method, Validation.