Abstract
A reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of atorvastatin calcium and fenofibrate in tablet formulation. The separation was achieved by Luna C18 column and methanol:acetate buffer pH 3.7 (82:18 v/v) as mobile phase, at a flow rate of 1.5 ml/min. Detection was carried out at 248 nm. Retention time of atorvastatin calcium and fenofibrate was found to be 3.02+0.1 and 9.05+0.2 min, respectively. The method has been validated for linearity, accuracy and precision. Linearity for atorvastatin calcium and Fenofibrate were in the range of 1-5 μg/ml and 16-80 μg/ml, respectively. The mean recoveries obtained for Atorvastatin calcium and fenofibrate were 101.76% and 100.06%, respectively. Developed method was found to be accurate, precise, selective and rapid for simultaneous estimation of atorvastatin calcium and fenofibrate in tablets.
Highlights
A reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of atorvastatin calcium and fenofibrate in tablet formulation
Atorvastatin calcium [1,2] (AC) is (β R, δ R)-2-(4fluorophenyl)-β,δ-dihydroxy-5-(1-methyl ethyl)-3phenyl-4-((phenyl amino)carbonyl)-1H-pyrrole-1hepatonoic acid, a HMG CoA reductase inhibitors and fenoÞbrate[3,4,5,6,7,8,9] (FB) is 2-[4-(4-chlorobenzoyl)phenoxy]2-methyl-propanoic acid, 1-methylethyl ester. It is indicated for the treatment of hypercholesterolemia and mixed dyslipidemia11
3.7 in the ratio of 82:18% v/v was used as mobile phase and was filtered before use through 0.45 μ membrane Þlter
Summary
3.7 in the ratio of 82:18% v/v was used as mobile phase and was filtered before use through 0.45 μ membrane Þlter. Standard stock solution of AC and FB (1000 μg/ml) was prepared in a mixture of methanol and water (80:20 v/v) as diluent separately. The standard solutions were further diluted to contain a mixture of 32 μg/ml of AC and 2 μg/ml of FB. With the above mobile phase a good resolution between AC and FB was achieved with a reasonably short runtime of 10 min. The criteria employed for assessing the suitability of above said solvent system were cost, time required for analysis, solvent noise, preparatory steps involved and the use of same solvent system for the extraction of drug from the formulation excipient matrix for the estimation of drug content. UV detection was carried out at 248 nm as AC and FB both showed good absorbance at this wavelength
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