Pharmacokinetics and bioequivalence study of amlodipine and atorvastatin in healthy male volunteers by LC-MS

Background: a quick and thoughtful liquid chromatography-tandem mass spectrometry (lc-ms) method has been established and authorized for the estimation of amlodipine and atorvastatin in human plasma. methods: lc-ms with electrospray ionization (esi) interface in positive ion mode was functioned under the multiple-reaction monitoring (mrm) mode was used for detection of analytes. ethyl acetate was secondhand for extraction of analytes from plasma by simple liquid-liquid extraction technique. the re-formed samples with a c18 column by pumping acetonitrile-ammonium acetate buffer (10 mm,ph = 3.0),70:30 (v/v) at a flow rate of 0.15 ml/min were chromatographed. the standard curves were established to be linear in the range of 0.2-20 ng/ml for atorvastatin and 0.1-10 ng/ml for amlodipine with mean correlation coefficient of ≥0.999 for each analyte. results: the lower limit of quantification for amlodipine and atorvastatin were demonstrated to be 0.1 ng/ml and 0.2 ng/ml respectively. the mean (sd) cmax and tmax values of amlodipine later supervision of the test and reference were: 6.58 (0.22) versus 6.64 (0.37) ng/ml,6.12(0.86) versus 6.13 (0.73) hours respectively. the mean (sd) cmax and tmax values of atorvastatin later government of the test and reference,were 61.66 (3.05) versus 62.16 (0.76) ng/ml,4.21(0.86) versus 4.22 (0.73) hours respectively. conclusion: the results proposed the test formulation of amlodipine and atorvastatin is bioequivalence with reference formulation and the established evaluate method was successfully realistic to a pharmacokinetic and bioavailability trainings in 20 human male volunteers following oral administration of amlodipine and atorvastatin. © 2015 the authors.