Method Development And Validation Of Stability Indicating Rp-Hplc Method For The Estimation Of Atrovastatin And Fenofibrate Combination In Tablet Dosage Form

Abstract

A stability indicating RP-HPLC method was developed and validated for the determination of Atorvastatin and Fenofibrate in tablet dosage form. The method was carried out using Agilent C18 column (100 mm×4.6 mm, 2.5μ) with mobile phase consisting 0.1 % ortho-phosphoric acid and Methanol (25:75 v/v), at a flow rate of 1.0 mL/min and the effluent monitored at 257 nm. The retention time of Atorvastatin and Fenofibrate were found to be 5.254 and 7.341 min respectively. Linearity was observed over the concentration range of 1-5 μg/mL for Atorvastatin and 16-80 μg/mL for Fenofibrate. The percentage recoveries of Atorvastatin and Fenofibrate in the marketed dosage form found to be 100.27 and 99.55 respectively. The reliability and analytical performance of the proposed method were statistically validated for linearity, precision, accuracy, and ruggedness, Limit of detection, and quantification limits. The drug was subjected to stress conditions including acidic, alkaline, oxidation, photolysis and humidity degradation. The drug is more sensitive towards oxidation degradation. The method was validated as per ICH guidelines.