Pharmacokinetics and Bioequivalence Study of Amlodipine and Atorvastatin in Healthy Male Volunteers by LC-MS

Abstract

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.

Keywords: Amlodipine, ,, Atorvastatin, LC-MS,, Pharmacokinetics, Human plasma, Bioequivalence