Validated Method Development for Estimation of Atorvastatin Calcium and Fenofibrate in Fixed Dose Combination by HPTLC

P. B. Deshpande, G. Shridharan, Libi Anandi, D. Jadhav, M. C. Damle, S. V. Gandhi

Abstract: A simple high-performance thin-layer chromatographic method has been developed and validated for determination of atorvastatin calcium and fenofibrate in a fixed dose combination. The drugs were separated on aluminum plates precoated with silica gel 60 F254 using chloroform–methanol (8:2 v/v) as solvent system. The drugs were well resolved with Rf values 0.29 and 0.77 for atorvastatin calcium and fenofibrate, respectively. Quantitative analysis was performed by densitometric scanning at 285 nm. The method was validated for linearity, accuracy, precision, specificity and robustness. The calibration plot was linear over the ranges 200–1000 and 320–1600 ng/band for atorvastatin calcium and fenofibrate, respectively. The method was successfully applied to the analysis of drugs in a pharmaceutical formulation.
Atorvastatin calcium is a selective competitive inhibitor of the enzyme HMG-CoA reductase that catalyses conversion of HMG-CoA to mevalonate, an important rate-limiting steps in cholesterol biosynthesis. Fenofibrate is a lipid lowering agent.

Literature survey reveals that few HPLC and HPTLC methods have been reported for estimation of atorvastatin calcium and fenofibrate in combination with other drugs. One HPTLC method reported by Chaudhari et. al. for simultaneous estimation of atorvastatin calcium and fenofibrate used toluene:methanol:acetic acid (08:02:02 v/v/v) as solvent system. The limitation of this method primarily is high Rf value for fenofibrate (0.88) which makes precise densitometric evaluation rather difficult due to interference by solvent front.

Chemicals and Reagents
Pharmaceutical grade atorvastatin calcium and fenofibrate were obtained as gifts from Mepro Pharmaceuticals Pvt. Ltd., Wadhawan (Gujarat) and A TO Z Pharmaceuticals Pvt. Ltd., Chennai (Tamilnadu), respectively. Fixed dose combination tablets containing 10 mg of atorvastatin calcium and 160 mg of fenofibrate were purchased from local market. All chemicals used were of analytical-grade. 


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