Simultaneous determination of sarpogrelate and its active metabolite in human plasma by liquid chromatography with tandem mass spectrometry and its application to a pharmacokinetic study

被引:7
作者
Park, Jung Bae
Bae, Soo Kyung
Bae, Soo Hyeon
Oh, Euichaul [1 ,2 ]
机构
[1] Catholic Univ Korea, Coll Pharm, Puchon 420743, Gyeonggi Do, South Korea
[2] Catholic Univ Korea, Integrated Res Inst Pharmaceut Sci, Puchon 420743, Gyeonggi Do, South Korea
基金
新加坡国家研究基金会;
关键词
Active metabolites; human plasma; method validation; pharmacokinetics; sarpogrelate; IMMEDIATE-RELEASE FORMULATION; 5-HT2A RECEPTOR; LC-MS/MS; HYDROCHLORIDE; FOOD;
D O I
10.1002/jssc.201400884
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
We established a rapid and simple liquid chromatography with tandem mass spectrometry method for the simultaneous determination of sarpogrelate and its active metabolite, M-1, in human plasma. Sarpogrelate, M-1, and the internal standard, ketanserin, were extracted from a 50 mu L aliquot of human plasma by protein precipitation using acetonitrile. Chromatographic separation was performed on a Shim-pack GIS ODS C-18 column (100 x 3.0 mm; 3 mu m) with an isocratic mobile phase consisting of 10 mM ammonium acetate and acetonitrile (70:30, v/v) at a flow rate of 0.6 mL/min; the total run time was <2.5 min. Mass spectrometric detection was conducted in selected reaction-monitoring mode with positive electrospray ionization at m/z 430.35 -> 135.10 for sarpogrelate, m/z 330.30 -> 58.10 for M-1, and m/z 395.70 -> 188.85 for ketanserin. The linear ranges of concentration for sarpogrelate and M-1 were 1-1000 and 0.5-500 ng/mL, respectively. The coefficient of variation for the assay's precision was <= 9.95%, and the accuracy was 90.6-107%. All analytes were stable under various storage and handling conditions, and no relevant crosstalk and matrix effect was observed. This method was successfully applied to a pharmacokinetic study after oral administration of a 100 mg sarpogrelate tablet to healthy male Korean volunteers.
引用
收藏
页码:42 / 49
页数:8
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