Simultaneous determination of ezetimibe, atorvastatin and simvastatin using quadrupole LC-MS: Application to combined tablets and plasma after SPE

Abstract A simple and sensitive liquid chromatography-mass spectrometric (LC-MS) method has been developed validated for the simultaneous determination of ezetimibe (EZE), atorvastatin calcium (ATO), simvastatin (SMV) in combined dosage forms human plasma. Successful separation studied drugs was achieved on a Zorbax Eclipse Plus C18 column (3.0 × 150 mm, 5 µm) using mobile phase consisting acetonitrile 0.1% formic acid water (65:35, v/v) at flow rate 0.5 mL min −1 . Total run time 9.3 diclofenac sodium used as internal standard (IS). Positive selected ion monitoring (SIM) mode applied where, monitored ions were those m / z values 392.1, 559.3, 296.0, 441.4 corresponding to EZE, ATO, IS, SMV, respectively. The fully according ICH guidelines. intraday interday precision showed relative SD not more than 1.77 1.99%; limits detection (LOD) 0.25, 0.75 ng while quantification (LOQ) 1.25, 0.75, 2.5 two types tablets concerning drug assay with mean percent recoveries within acceptable range. extended plasma solid extraction optimized their recovery less 97%.