Simultaneous Determination of Simvastatin and Ezetimibe in Tablets by HPLC

Abstract

A reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of simvastatin and ezetimibe in tablet dosage forms. The separation was effected on a C18 Supelcosil column (250 mm x 4.6 mm; 5µ) using a mobile phase consisting of 0.01 M ammonium acetate buffer and acetonitrile (35:65v/v) at a flow rate of 1 mL/min. The detection was made at 240 nm. The retention times for ezetimibe and simvastatin were 5.9 and 8.5 min respectively. Calibration curves were linear over the ranges of 0.5-40 µg/mL for simvastatin and 2.5-50 µg/mL for ezetimibe. The proposed method was validated as per the ICH and USP guidelines. The method is accurate and precise and found to be suitable for the quantitative analysis of both the drugs individually and in combination in tablet dosage forms.

Recent Trends in Analytical Techniques for the Development of Pharmaceutical Drugs

“…The aim of this study was to develop and validate for determination of piroxicam in human plasma by new rapid HPLC method and to compare the relative bioavailability of two branded formulations of piroxicam in healthy Korean volunteers [8]. Bioanalytical, HPLC and stability indicating HPLC methods are reported for its individual determination and in combination with other drugs [9][10][11][12].This work is concerned with the research and development of methodology for analysis of complex mixtures such as pharmaceutical or food samples, which contain many analytes Automated development in HPTLC: High performance thin layer chromatography (HPTLC) is an enhanced form of thin layer chromatography (TLC). A number of enhancements can be made to the basic method of thin layer chromatography to automate the different steps, to increase the resolution achieved and to allow more accurate quantitative measurements.…”

Simultaneous Estimation of Atorvastatin, Ezetimibe and Fenofibrate in Pharmaceutical Formulation by RP-LC-PDA

“…Most of the time AT and EZ eluted with very small value of retention factor (k) associated with long retention time (t R ) for FE. With regards to the mobile phase acetonitrile was used as composition of the mobile phase used for determination of AT with its impurities, AT with amlodipine, AT with ramipril and aspirin, AT + FE, EZ, AT+EZ, EZ with simvastatin, FE and EFNO with vinpocetine [7][8][9][10][15][16][17]25,26]. During method development preference was given to methanol as solvent of choice.…”

“…Co-administration of ezetimibe with statins could provide an additional reduction in LDL cholesterol as well as total cholesterol [14]. Bioanalytical, HPLC and stability indicating HPLC methods are reported for its individual determination and in combination with other drugs [15][16][17][18][19][20][21]. Fenofibrate (FE); chemically 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid 1-methylethyl ester, is a lipid regulating agent.…”

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“…All statins act by inhibiting 3-hydroxy-3methylglutaryl coenzyme A HMG-CoA reductase, the rate limiting enzyme of the HMG-CoA reductase path way, the metabolic path way responsible for the endogenous production of cholesterol mainly used for the treatment of dislipidimia and the prevention of cardiovascular diseases . SIM can be estimated by different analytical techniques, they are RP-HPLC [9][10][11][12] , derivative Spectrophotometry 13 , spectrophotometry [14][15] , second order derivative 16 , LC-MS/MS 17 .…”