Methodological Studies of the Determination of Lacidipine in Human Plasma by HPLC-MS/MS
- VernacularTitle:HPLC-MS/MS法测定人血浆中拉西地平药物浓度的方法学研究
- Author:
Su SU
;
Zhizhou WANG
;
Qian SHEN
;
Suying YAN
- Keywords:
Lacidipine;
LC-MS/MS;
Methodological evaluation;
Drug concentration in human plasma
- From:
China Pharmacist
2017;20(7):1196-1200
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To develop a method for the determination of lacidipine (LAC) in human plasma.Methods: After liquid-liquid extraction with tert-butyl methyl ether, the plasma samples were analyzed by LC-MS/MS.Using lacidipine-13C8 as the internal standard, a Agilent ZORBAX Eclipse XDB C18 column (150 mm×2.1 mm, 5 μm) was used with the mobile phase consisting of water(containing 5 mmol·L-1 ammonium formate)-acetonitrile(15∶85,v/v)at a flow rate of 0.3 ml·min-1 and with the column temperature at 40 ℃.The ion transitions were performed in a positive electrospray ionization multiple reaction-monitoring mode regarding + as the molecular ion peak of lacidipine and monitoring with m/z 473.5→m/z 410.3, m/z 473.5→m/z 400.1 and m/z 473.5→m/z 354.3.The internal standard was monitored with m/z 481.4→m/z 362.3.Results: The linear range of lacidipine was 0.1-10 ng·ml-1 (r＞0.99) and the lower quantification limit was 0.1 ng·ml-1.The intra-and inter-day RSDs were 3.15%-7.04% and the relative error was from-8.58% to 12.71%.The mean relative recovery of lacidipine was from 107% to 118% (RSD＜15%).The plasma samples were stable at-20℃ for 40 d and kept stable after three repeated freeze-thaw cycles.The prepared samples were stable at room temperature for 24 h and in the automatic sample injector (4℃) for 24 h(RSD＜15%).Conclusion: The developed assay method can be applied in the bioequivalence evaluation and pharmacokinetic studies of lacidipine in human.
