Volume :
2
Issue :
3
Abstract :
A simple, rapid, precise and accurate isocratic reversed phase stability indicating RP- HPLC method was developed and validated for the simultaneous determination of Atorvastatin calcium and Fenofibrate in commercial tablets. The chromatographic separation was achieved on Phenomenex Luna C18 (250×4.6mm, 5μm) column using a mobile phase consisting of methanol and buffer (0.1% v/v triethylamine pH 3.5 adjusted with 0.1% v/v orthophosphoric acid) in the ratio of (90:10% v/v) at a flow rate of 1.0 ml/min and UV detection at 254 nm. The linearity of the proposed method was investigated in the range of 2.5-5 μg/ml (r2=0.9984) for Atorvastatin calcium and 2.5-5 μg/ml (r2=0.9987) for Fenofibrate. Retention time of Atorvastatin calcium and Fenofibrate were found to be 3.020 and 6.101. The method was validated for accuracy, repeatability, reproducibility and robustness, system suitability. LOD of Atorvastatin calcium and Fenofibrate were found to be 0.05901µg/ml and 0.03764µg/ml and LOQ of Atorvastatin calcium and Fenofibrate were found to be 0.19651µg/ml and 0.12547µg/ml. The stability studies of Atorvastatin calcium and Fenofibrate were conducted and the degradation characteristics were found to be much more prominent in alkaline hydrolysis (alkaline stress condition).