Simultaneous determination of ezetimibe and atorvastatin calcium in spiked human plasma using SPE coupled to HPLC-MS/MS

Abstract

Combination drug products containing ezetimibe (EZB) and atorvastatin calcium (ATVC) are widely used for treatment of hyperlipidemia. A rapid, simple and sensitive liquid chromatography tandem mass spectrometry (LC-MS/MS)method for determination of EZB and ATVC in spiked human plasma has been developed and validated.Plasma samples were subjected to solid phase extraction before analysis with an extraction recovery of 90.59 - 98.02%. Chromatographic separation was performed on a C18 col- umn using isocratic elutionwithin 2 min run time. The mobile phase con- sisted of acetonitrile: 1% of formic acid in water (8: 2, v/v) and was pumped at a flow rate of 0.8 mL/min. Detection of analytes was achieved by with electrospray ionization (ESI) in negative ion mode for EZB and positive ion mode for ATVC. The calibration curves were linear over the range of 1.67 83.33 ng/mL for both drugs. The precision at the lower limit of quantitation for EZB (12.97%) and ATVC (8.99%) was determined. The intra- and inter- day precisions were within 9.16%, while the accuracy ranged from 94.18 to 106.94%. The validated LC-MS/MS method was successfully employed for thedetermination of EZB and ATVC in spiked human plasma for application in therapeutic drug monitoring.  2014 Trade Science Inc. - INDIA