Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF TDF IN PHARMACEUTICAL FORMULATION

Umesh Ramnarayan Maniyar*, Dr. MayaVijay Katariya, Kishor Kumar Koshe, Gopal Satyanarayan Karva, Sushil Hiralal Jaiswal

ABSTRACT

A simple and accurate RP-HPLC method was developed and validated for analysis of Tenofovir disproxil fumarate (TDF) by Shimadzu HPLC using Inertsil ODS-3 (150 mm x 4.6 mm), 5m column and mobile phase Sodium dihydrogen orthophosphate, dihydrate pH 2.3 in the ratio of 49:51 % v/v and UV detection was carried out at 260 nm with the flow rate 1.0 mL/min employing 13 min run time. The used method is specific for the estimation of TDF in presence of their degradation products and impurities. The retention time was observed at 9.2min. The method was validated with respect to system suitability, linearity, precision, accuracy, and robustness. A linearity study was performed (150–450 μg/ml), the RSD for precision were found to be less than 2 %. The mean percentage recovery was 99.2% to 100.4 %. The forced photolytic, thermal and humidity degradation studies were carried out. Behavior shows that the major degradation was observed at basic condition i.e .NaOH (7.2%) followed by HCl (2.7%). All the results proved that the developed method is economical simple, specific, precise, robust and accurate for the determination of TDF in formulations.

Keywords: Tenofovir, RP-HPLC, Method development, Validation, Forced degradation.