Research Article
N. Khaleel1* and Sk. Abdul Rah
Abstract
The main aim of the present research work was to develop a new simple, precise, selective, accurate and rapid reverse phase high performance liquid chromatographic stability indicating method had been developed and validated for simultaneous quantitative determination of Atorvastatin, Fenofibrate and Folic acid in bulk and pharmaceutical dosage form. The chromatographic separation was achieved with Agilent XDB C18 150×4.6 mm, 5μm particle size column. The optimized mobile phase consisting of pH 3.3 Phosphate buffer: Acetonitrile (30:70 %v/v). The flow rate was 1.0 mL/min and eluents were detected at 280 nm using PDA detector. The retention time of Folic acid, Atorvastatin, Fenofibrate were found to be 2.507, 3.202 and 6.005 respectively. The percentage recoveries for Folic acid, Atorvastatin, Fenofibrate were found to be in the range of 100.26 -100.69 %, 100.01 – 100.81 % and 100.05 – 100.97 %. The calibration curve was constructed between peak area vs concentration and demonstrated good linear in the range of 5 -30 μg/ml for Atorvastatin, 80-480 μg/ml for Fenofibrate and 2.5-15 μg/ml for Folic acid. Degradation studies were studied for Atorvastatin, Fenofibrate and Folic acid under various stress conditions such as acid hydrolysis, base hydrolysis, oxidation, thermal, photochemical and UV. All the degradation peaks were resolved effectively using developed method with different retention times. The developed method was validated according to ICH guidelines. As the method could effectively separates the degradation products from active ingredient, it can be used for routine analysis of drug both in bulk and pharmaceutical dosage form.