Determination and pharmacokinetic study of amlodipine in human plasma by ultra performance liquid chromatography-electrospray ionization mass spectrometry.
A novel, specific and sensitive ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method was developed for the determination and pharmacokinetic study of amlodipine in human plasma. The analysis was carried out on an ACQUITY UPLC BEH C(18) column (50 mm x 2.1 mm, i.d., 1.7 microm) with gradient elution at a flow-rate of 0.35 ml/min. The mobile phase was water and acetonitrile under gradient conditions (both containing 0.3% formic acid) and nimodipine was used as the internal standard. Detection was performed on a triple-quadrupole tandem mass spectrometer by multiple reaction monitoring (MRM) mode via Turbo ion spray ionization (ESI). Linear calibration curves were obtained over the concentration range 0.15-16.0 ng/ml, with a lower limit of quantification of 0.15 ng/ml. The intra- and inter-day precision (R.S.D.) values were below 15% and the accuracy (R.E.) was -2.3% to 6.9% at all three QC levels. The method was used to support clinical pharmacokinetic studies of amlodipine in healthy volunteers following oral administration.
Ma
Yuanyuan
Y
Department of Analytical Chemistry, Shenyang Pharmaceutical University, Shenyang 110016, PR China.
Qin
Feng
F
Sun
Xiaohong
X
Lu
Xiumei
X
Li
Famei
F
D000284:Administration, Oral; D017311:Amlodipine / Q000008:administration & dosage / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics*; D002121:Calcium Channel Blockers / Q000008:administration & dosage / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics*; D002853:Chromatography, Liquid / Q000379:methods*; D002986:Clinical Trials as Topic; D006801:Humans; D008297:Male; D015394:Molecular Structure; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*; D013607:Tablets; D053719:Tandem Mass Spectrometry; D013997:Time Factors
D002121:Calcium Channel Blockers; D013607:Tablets; D017311:Amlodipine