A new stability indicating RP-HPLC method development and validation for simultaneous estimation of emtricitabine and tenofovir with degradation kinetics.

Abstract

A new, simple, rapid and stability-indicating RP-HPLC method was developed for the estimation of Emtricitabine (EMT) and Tenofovir disoproxil fumarate (TDF) in pharmaceutical dosage forms and validated. The HPLC method was developed on SHISEIDO C18 column (250 x 4.6 mm i.d, 5μ) using methanol: 20mM phosphate buffer (pH 5.0) in the ratio of 35: 65 v/v at 271 nm. The retention times for EMT and TDF was found to be 2.79 and 4.91 min respectively. Linearity was established in the range of 0.5–1.5 μg/ml and 0.75–2.0 μg/ml for EMT and TDF 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 drugs were individually subjected to forced degradation (thermal, photolytic, hydrolytic, and oxidative stress conditions) studies for seven days. EMT showed maximum degradation in acidic medium and TDF showed maximum degradation in basic medium. The method was successfully applied for quantifying the drugs in marketed dosage forms.