STABILITY-INDICATING UV-VIS SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF ATORVASTATIN CALCIUM AND FENOFIBRATE IN TABLET DOSAGE FORM

The present research work discusses the development of a stability-indicating UV spectrophotometric method for the estimation of Atorvastatin calcium (ATC) and Fenofibrate (FEN) in tablet dosages form. The optimum conditions for the analysis of the drug were established. The maximum wavelength (λmax) was found to be 247 nm for ATC and 287 nm for FEN. The linearity of the proposed method was investigated in the range of 6-16 ?g/ml and 2-12 ?g/ml for ATC, FEN respectively. Calibration curves showed a linear relationship between the absorbance and concentration. The line equation for ATC (y = 0.041x + 0.043) with r2 of 0.999 and for Fenofibrate (y = 0.054x - 0.003) with r2 of 0.999, was obtained. Validation was performed as per ICH guidelines for linearity, accuracy, precision, LOD and LOQ. The LOD was 0.2695 ?g/ml, 0.0222 ?g/ml for ATC and FEN and the LOQ was 0.8780 ?g/ml, 0.222 ?g/ml for ATC and FEN respectively. The proposed method may be suitable for the analysis of ATC and FEN in tablet formulation for quality control purpose. The proposed methods were simple, sensitive, precise, accurate, quick and useful for routine quality control. The stability studies of ATC and FEN were conducted and the degradation characteristics were found to be much more prominent in acid hydrolysis in FEN and alkaline hydrolysis in ATC.