Ultra-performance liquid chromatography-tandem mass spectrometry for the determination of lacidipine in human plasma and its application in a pharmacokinetic study.
A selective, rapid and sensitive ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-ESI-MS/MS) method was developed and validated for the quantification of lacidipine in human plasma. With nifedipine as an internal standard, sample pretreatment involved a simple liquid-liquid extraction with tert-butyl methyl ether of 1 ml plasma. The analysis was carried out on an Acquity UPLC BEH C18 column (50 mm x 2.1 mm, 1.7 microm) with flow rate of 0.28 ml/min. The mobile phase was 30 mM ammonium acetate buffer-acetonitrile (18:82, v/v, pH 5.5). The detection was performed on a triple-quadrupole tandem mass spectrometer by multiple reaction monitoring (MRM) mode via electrospray ionization (ESI). Linear calibration curves were obtained in the concentration range of 0.025-10.000 ng/ml, with a lower limit of quantification of 0.025 ng/ml. The intra- and inter-day precision (R.S.D.) values were below 15% and accuracy (RE) was -12.7% to 11.9% at all QC levels. The method was successfully applied to a clinical pharmacokinetic study of lacidipine in healthy volunteers following oral administration.
Tang
Jing
J
Clinical Pharmacy & Pharmacology Institute, The Second Xiang Ya Hospital, Central South University, Changsha 410011, PR China.
Zhu
Ronghua
R
Zhao
Ruike
R
Cheng
Gang
G
Peng
Wenxing
W
D000085:Acetates / Q000737:chemistry; D000284:Administration, Oral; D002021:Buffers; D002121:Calcium Channel Blockers / Q000008:administration & dosage / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics*; D002138:Calibration; D002853:Chromatography, Liquid / Q000379:methods*; D002986:Clinical Trials as Topic; D004095:Dihydropyridines / Q000008:administration & dosage / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics*; D004355:Drug Stability; D005615:Freezing; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008738:Methyl Ethers / Q000737:chemistry; D015394:Molecular Structure; D009543:Nifedipine / Q000737:chemistry; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D021241:Spectrometry, Mass, Electrospray Ionization; D013607:Tablets / Q000737:chemistry; D053719:Tandem Mass Spectrometry / Q000379:methods*
D000085:Acetates; D002021:Buffers; D002121:Calcium Channel Blockers; D004095:Dihydropyridines; D008738:Methyl Ethers; D013607:Tablets; C060285:lacidipine; C043243:methyl tert-butyl ether; D009543:Nifedipine; C018824:ammonium acetate