Determination of lercanidipine in human plasma by an improved UPLC-MS/MS method for a bioequivalence study

被引：11
作者：
Chaudhary, Darshan V. [1 ]
Patel, Daxesh P. [2 ]
Shah, Priyanka A. [1 ]
Shah, Jaivik V. [1 ]
Sanyal, Mallika [3 ]
Shrivastav, Pranav S. [1 ]
机构：
[1] Gujarat Univ, Sch Sci, Dept Chem, Ahmadabad 380009, Gujarat, India
[2] NCI, Lab Metab, Ctr Canc Res, NIH, Bldg 37,Room 3106, Bethesda, MD 20892 USA
[3] St Xaviers Coll, Dept Chem, Ahmadabad 380009, Gujarat, India
来源：
JOURNAL OF PHARMACEUTICAL ANALYSIS | 2016年 / 6卷 / 02期
关键词：
Bioequivalence; Human plasma; Lercanidipine; Solid phase extraction; UPLC-MS/MS;
D O I：
10.1016/j.jpha.2015.09.001
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
An improved and reliable ultra-performance liquid chromatography/tandem mass spectrometry (UPLC-MS/MS) method has been developed and validated for the determination of lercanidipine in human plasma. Plasma samples with lercanidipine-d3 as an internal standard (IS) were prepared by solid phase extraction on Phenomenex Strata-X cartridges using 100 mu L of human plasma. Chromatographic analysis was performed on UPLC BEH C-18 (50 mm x 2.1 mm, 1.7 mu m) column under isocratic conditions. Linear calibration curves were obtained over a wide dynamic concentration range of 0.010-20.0 ng/mL. Matrix effect was assessed by post-column infusion, post-extraction spiking and standard-line slope methods. The mean extraction recovery was > 94% for the analyte and IS. Inter-batch and intra-batch precision (% CV) across five quality controls was <5.8%. Bioequivalence study was performed with 36 healthy subjects after oral administration of 10 mg of lercanidipine and the assay reproducibility was evaluated by reanalysis of 133 incurred samples. (C) 2015 Xi'an Jiaotong University. Production and hosting by Elsevier B.V.
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收藏
页码：87 / 94
页数：8
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