Abstract

STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE IN COMBINED PHARMACEUTICAL DOSAGE FORM

Umesh Maniyar*, Dr. M. V. Katariya, Kishor Kumar Koshe, Gopal Karva, Sushil Jaiswal

ABSTRACT

A very accurate and precise simultaneous estimation by stability indicating RP-HPLC gradient method was developed for Assay test of Efavirenz, Emtricitabin and Tenofovir disoproxil tablet dosage form. The experiment was carried out on Hypersil BDS C18, (150mm x 4.6 mm), 5μm column using the gradient composition of phosphate buffer pH 3.5 as mobile phase A and mixture of methanol, acetonitrile and water 500:350:150 v/v. degas as mobile phase B at flow rate 1.5ml/min and detection wavelength 265 nm. The retention time of Efavirenz was about 13.8 min, Emtricitabin was about 2.9 min and Tenofovir disoproxil was about 8.0 min.(Figure A). The detector response was linear from in the range of 50 % to 150 % test concentration i.e. 120.00 ppm to 360.00 ppm for Efavirenz, 40.00 ppm to 120.00 ppm for Emtricitabine and 60.00 ppm to 180.00 ppm for Tenofovir disoproxil fumarate.

Keywords: Estimation by stability indicating RP-HPLC gradient method was developed for Assay test of Efavirenz, Emtricitabin and Tenofovir disoproxil in tablet dosage form, Shimadzu HPLC with PDA detector, Hypersil BDS C18, (150mm x 4.6 mm), 5?m.