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 multiplereaction 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. A r t i c l e I n f o Article History: Received: 13 October 2015 Accepted: 12 November2015 ePublished: 18 November 2015