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THE PHARMA REVIEW
(MAY 2009) |
Validated Method Development
for Estimation of Atorvastatin Calcium and Fenofibrate
in Fixed Dose Combination by HPTLC
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P. B. Deshpande, G.
Shridharan, Libi Anandi, D. Jadhav, M. C. Damle, S. V.
Gandhi |
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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.
Introduction
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.
Experimental
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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