Novel Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC) Method Development and Validation of Atorvastatin and Fenofibrate in Tablets

A novel, simple, selective, precise, and accurate reverse-phase high-performance liquid chromatography (RP-HPLC) gradient method was developed for the simultaneous estimation of atorvastatin and fenofibrate in the combined formulation. The drugs atorvastatin calcium and fenofibrate were separated in the presence of their impurities atorvastatin related compound H, fenofibrate related compound A, and fenofibrate related compound B. The drugs and related compounds were separated on Kromasil C18 (250 x 4.6, 5μ) with reverse-phase gradient elution. Water adjusted pH 4.0 with phosphoric acid used as a buffer in pump A and acetonitrile used as a solvent in pump B as a mobile phase with gradient elution. The flow rate was 2.0 mL/min. 254 nm was the detection wavelength. The retention times were about 4.6 minutes for fenofibrate related compound A, 5.2 minutes for atorvastatin calcium, 5.7 minutes for fenofibrate related compound B, 8.7 minutes for atorvastatin related compound H, and 17.6 minutes for fenofibrate. The linearity ranges for atorvastatin calcium and fenofibrate were 5.00 to 15.00 and 80 to 240 mcg/mL, respectively, with correlation coefficient 0.999 for both. The proposed method validated statistically with respect to system suitability, specificity, linearity, precision, accuracy, range, robustness, and ruggedness. The method was accurate, linear, precise, specific, selective, and rapid suitable for the quantitative estimation of atorvastatin and fenofibrate in tablets.