Abstract

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF EMTRICITABINE AND TENOFOVIR IN TABLET DOSAGE FORMS BY RP-HPLC METHOD

Sk. Sattar* and D. Tirumala

ABSTRACT

A novel technique was recognized for simultaneous evaluation of Emtricitabine & Tenofovir by RP-HPLC method. The chromatographic situations were successfully developed for separation of Emtricitabine & Tenofovir by using Inertsil-C18 ODS column (250x4.6 mm, 5 μ). Flow rate was 1.0ml/min, the mobile phase ratio was Acetonitrile (C2H3N): methanol (CH3OH) at 90:10V/V. The detection of wavelength was 241nm. Insertion volume was chosen to be 20.0μl which gave a good quality peak area. The developed and validated technique was productively used for the quantitative analysis of commercially obtainable dosage forms. The maintenance times of Emtricitabine-2.955mins & Tenofovir are found to be-3.538mins. The method is validated according to ICH guiding principles. The linearity of Emtricitabine & Tenofovir found in absorption range of 20μg-80μg and the correspondence coefficient is found to be 0.9996 and 0.9997, LOD values for Emtricitabine is 0.17727 and for Tenofovir 0.0554, LOQ standards were found to be 0.53716 for Emtricitabine and 0.1678 for Tenofovir respectively.

Keywords: Inertsil-C18 ODS column, Emtricitabine, Tenofovir and RP-HPLC