Abstract
The present manuscript describes the development and validation of an isocratic reverse phase high-performance liquid chromatographic (RP-HPLC) method for the estimation of Atorvastatin calcium and Fenofibrate in raw material and tablet. Atorvastatin Calcium, Fenofibrate and Diclofenac (internal standard) were well separated using a reversed phase column and mobile phase consisting of acetonitrile:KH2PO4(50 mM) (72:28v/v) (pH 4.1). The mobile phase was pumped at 1.0 mL/min flow rate and atorvastatin calcium and fenofibrate were detected by UV-Vis detection at 260 nm. The retention time for atorvastatin calcium, Internal Standard and fenofibrate were 4.34, 5.35 and 12.05 min, respectively. The LOD and LOQ was found to be 1.95 and 4.80 µg/mL for atorvastatin calcium whereas for fenofibrate it was found to be 1.73 and 3.98 µg/mL in mobile phase. The developed method was validated by applying parameters as precision, accuracy, selectivity, reproducibility and system suitability tests.
Highlights
Atorvastatin calcium 1-4 (ATR) is (β R, δ R)-2-(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methyl ethyl)-3-phenyl-4-((phenyl amino)carbonyl)-1H-pyrrole-1-hepatonoic acid, a HMG CoA reductase inhibitor
Literature survey reveals that, few HPLC and HPTLC methods have been reported for simultaneous estimation of ATR and Fenofibrate 3-7 (FB) as well as in combination with other drugs
The methods reported by Jain and Kadav 7 were excluding the internal standard, which was found to be the limitation of the method
Summary
Atorvastatin calcium 1-4 (ATR) is (β R, δ R)-2-(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methyl ethyl)-3-phenyl-4-((phenyl amino)carbonyl)-1H-pyrrole-1-hepatonoic acid, a HMG CoA reductase inhibitor. Fenofibrate 3-7 (FB) is 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid, 1-methylethyl ester, it is a lipid lowering agent. Literature survey reveals that, few HPLC and HPTLC methods have been reported for simultaneous estimation of ATR and FB as well as in combination with other drugs. N. Jain, et al 6 has reported HPLC method for simultaneous estimation of ATR and FB using methanol: acetate buffer pH 3.7 (82:18 v/v) as eluting solvent. The methods reported by Jain and Kadav 7 were excluding the internal standard, which was found to be the limitation of the method. Literature survey revealed number of spectroscopic and RP-HPLC method development for both drugs in
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