Simultaneous quantification of chlorogenic acid and taurocholic acid in human plasma by LC-MS/MS and its application to a pharmacokinetic study after oral administration of Shuanghua Baihe tablets  

作　　者：GU Pan LIU Rui-Juan CHENG Min-Lu WU Yao ZHENG Lu LIU Yu-Jie MA Peng-Cheng DING Li 

机构地区：[1]Department of Pharmaceutical Analysis,China Pharmaceutical University,Nanjing 210009,China [2]Nanjing Clinical Tech laboratories Inc.,Nanjing 211000,China [3]Yangtze River Pharmaceutical Group,Taizhou 225321,China [4]Institute of Dermatology,Chinese Academy of Medical Sciences and Peking Union Medical College,Nanjing 210042,China

出　　处：《Chinese Journal of Natural Medicines》2016年第4期313-320,共8页中国天然药物（英文版）

基　　金：supported financially by National Natural Science Foundation of China(No.81273482);the Graduate Innovation Fund of Zhejiang Huahai Pharmaceuticals Co.,Ltd

摘　　要：An LC-MS/MS method was developed and validated for the simultaneous quantification of chlorogenic acid(CGA) and taurocholic acid(TCA) in human plasma using hydrochlorothiazide as the internal standard. The chromatographic separation was achieved on a Hedera ODS-2 column with a gradient elution using 10 mmol·L^(-1) of ammonium acetate buffer solution containing 0.5% of formic acid- acetonitrile as mobile phase at a flow rate of 300 μL·min-1. The detection was performed on a triple quadrupole tandem mass spectrometer by multiple reaction monitoring in negative ESI mode. The method was fully validated over the concentration ranges of 0.1–10 ng·m L^(-1) for CGA and 2–150 ng·m L^(-1) for TCA. It was successfully applied to a pharmacokinetic study of CGA and TCA in healthy Chinese volunteers after oral administration of Shuanghua Baihe tablets(SBTs). In the single-dose study, the maximum plasma concentration(C_(max)), time to reach C_(max)(T_(max)) and elimination half-life(t_(1/2)) of CGA were(0.763 8 ± 0.542 0) ng·m L^(-1),(1.0 ± 0.5) h, and(1.3 ± 0.6) h, respectively. In the multiple-dose study, the C_(max), T_(max) and t_(1/2) of CGA were(0.663 7 ± 0.583 3) ng·m L^(-1),(1.1 ± 0.5) h, and(1.4 ± 0.7) h, respectively. For TCA, no significant characteristic increasing plasma TCA concentration-time curve was found in the volunteers after oral administration of SBTs, indicating its complicated process in vivo as an endogenous ingredient.An LC-MS/MS method was developed and validated for the simultaneous quantification of chlorogenic acid （CGA） and taurocholic acid （TCA） in human plasma using hydrochlorothiazide as the internal standard. The chromatographic separation was achieved on a Hedera ODS-2 column with a gradient elution using 10 mmol.L-1 of ammonium acetate buffer solution containing 0.5% of formic acid - acetonitrile as mobile phase at a flow rate of 300 μL.min-1. The detection was performed on a triple quadrupole tandem mass spectrometer by multiple reaction monitoring in negative ESI mode. The method was fully validated over the concentration ranges of 0.1-10 ng.mL 1 for CGA and 2-150 ng.mL I for TCA. It was successfully applied to a pharmacokinetic study of CGA and TCA in healthy Chinese volunteers after oral administration of Shuanghua Bathe tablets （SBTs）. In the single-dose study, the maximum plasma concentration （Cmax）, time to reach Cmax（Tmax） and elimination half-life （t1/2） of CGA were （0.763 8 ± 0.542 0） ng.mL-1, （1.0 ± 0.5） h, and （1.3 ± 0.6） h, respectively. In the multiple-dose study, the Cmax, Tmax and t1/2 of CGA were （0.663 7 ± 0.583 3） ng.mL-1, （1.1 ± 0.5） h, and （1.4 ± 0.7） h, respectively. For TCA, no significant characteristic increasing plasma TCA concentration-time curve was found in the volunteers after oral administration of SBTs, indicating its complicated process in vivo as an endogenous ingredient.

关 键 词：Chlorogenic acid Taurocholic acid Shuanghua Baihe tablets PHARMACOKINETICS LC-MS/MS 

分 类 号：R917[医药卫生—药物分析学]