ISSN: 2249–9504
CAS CODEN: IJPCDX

A NEW GRADIENT RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE AND EFFAVIRENZ IN PHARMACEUTICAL DOSAGE FORMS

Abstract

Author(s): KS. Sumanth1* , A. Srinivasa Rao2 and D. Gowri Shankar3

A new, simple, rapid and accurate gradient RP-HPLC method was developed for the estimation of Lamivudine (LAM), Tenofovir disoproxil fumarate (TDF) and Effavirenz (EFA) in pharmaceutical dosage forms and validated. The HPLC method was developed on SHISEIDO C18 column (250 x 4.6 mm i.d, 5µ) using Acetonitrile: 50mM phosphate buffer (pH 5.0) at 256 nm. The retention times for Lamivudine, Tenofovir disoproxil fumarate and Effavirenz were found to be 2.4, 4.1 and 12.2 min respectively. Linearity was established in the range of 5-25 μg/ml, 5-25 μg/ml and 10-50 μg/ml for LAM, TDF and EFA respectively. The coefficients of regression (R2) values were found to be 0.997, 0.995 and 0.997 for LAM, TDF and EFA respectively. The method was precise with %RSD < 2 for both intraday and interday precision. The accuracy of the method was performed over three levels of concentration and the recovery was in the range of 98-102%. The method was successfully applied for quantifying these drugs in marketed dosage forms.

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