Abstract

Stability indicating RP-HPLC method development and validation of Tenofovir in Bulk and Pharmaceutical formulation

Author(s): Sivaram Manavarthi*and Gurmeet Singh Chhabra

This study was aimed to develop stability indicating RP-HPLC method for analysis of Tenofovir. Successful separation of drug from degradation products formed under stress conditions was achieved by a gradient HPLC method, which was performed by Perkin Elmer HPLC using C18(Phenomenex 100 x 4.6 mm x 5 micron) Column and optimized mobile phase consists of Methanol as Solvent-A,10 mM potassium di hydrogen ortho phosphate buffer of pH -3 as a Solvent-B in the ratio of 30:70 % v/vand UV detection was carried out at 260 nm. The retention time was observed at 7.33 min. The method was validated with respect to system suitability, linearity, precision, accuracy, limit of detection (LOD), limit of quantification (LOQ) and robustness. Linearity studies was performed (20–100 μg/ml), LOD and LOQ was found to be 0.9 and 2.71 μg/ml respectively. The RSD for precision were found to be less than 2 %. The mean percentage recovery was 99.13% to 100.21 %.The forceddegradation studies were carried out by using 0.01N NaOH, 1.0 N HCl, 3 % H2O2. Degradation behavior shows that the major degradation was observed at basic condition i.e.NaOH (91.1 %) followed by HCl (48.04%) and H2O2 (47.44%).Tenofovir is more susceptible towards acidic, basic and oxidative conditions within 30 min study. The used method is specific for the estimation of Tenofovir in presence of their degradation products and impurities. Thus the method is simple, specific, precise, robust and accurate for the determination of Tenofovir in formulations.

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