Abstract

DEVELOPMENT AND VALIDATION OF NEW ANALYTICAL METHOD FOR THE SIMULTANEOUS ESTIMATION OF LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE BY UV-SPECTROPHOTOMETER

Barri Swathi*, B. Subramanyam, C. Lakshmi Prasanna, U. Keerthi, P. Sathwika, A. Samanvi

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Abstract

A simple, rapid and precise method is developed for the quantitative simultaneous determination of Lamivudine and Tenofovir disoproxil fumarate in combined pharmaceutical-dosage forms. The method was based on UV-Spectrophotometric determination of two drugs, using simultaneous equation method. It involves absorbance measurement at 290 nm (λmax of Lamivudine) and 287 nm (λmax of Tenofovir) in PHbuffer: ACN(60:40v/v). For UV Spectrophotometric method, linearity was obtained in concentration range of 1-50 µg/ml for Lamivudine and 1-50 µg/ml for Tenofovir disoproxil fumarate respectively, with regression 0.995 and 0.997 for Lamivudine and Tenofovir disoproxil fumarate respectively. Recovery was in the range of 99 -103%; the value of standard deviation and % R.S. D was found to be < 2 %; shows 0the high precision of the method., in accordance with ICH guidelines. The method has been successively applied to pharmaceutical formulation and was validated according to ICH guidelines.

Keywords: UV-spectrophotometer, Lamivudine, Tenofovir disoproxil fumarate.