Simultaneous Densitometric TLC Analysis of Atorvastatin Calcium and Fenofibrate in the Bulk Drug and in Pharmaceutical Formulations

The combination of atorvastatin calcium and fenofibrate is used for treatment of atherosclerotic vascular diseases. A simple, rapid, selective, and precise densitometric TLC method for simultaneous analysis of atorvastatin calcium and fenofibrate in pharmaceutical dosage forms has been established, and validated in accordance with ICH guidelines. Good resolution of atorvastatin calcium (RF 0.36 ± 0.02) and fenofibrate (RF value of 0.84 ± 0.02) was achieved on aluminum foil silica gel 60 F254 plates with toluene—methanol—triethylamine 7:3:0.2 (v/v) as mobile phase. Detection and quantification were performed densitometrically at 258 nm. Polynomial regression data for the calibration plots showed there was a good linear relationship between response and amount in the range 100–800 ng per band for atorvastatin calcium (r2 = 0.9983) and 1000–8000 ng per band for fenofibrate (r2 = 0.9982). The method was validated for precision accuracy, ruggedness, and recovery. The limits of detection and quantification were 25.41 and 77.02 ng, respectively, for atorvastatin calcium, and 292.40 and 886.09 ng for fenofibrate. Statistical analysis proved the method enables repeatable, selective, and accurate analysis of the drugs. The method can be used for identification and quantitative analysis of atorvastatin calcium and fenofibrate in the bulk drug and in dosage forms.