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.
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(-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 (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.
Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China; Nanjing Clinical Tech laboratories Inc., Nanjing 211000, China.
Pan
P
Gu
Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China; Nanjing Clinical Tech laboratories Inc., Nanjing 211000, China.
Rui-Juan
RJ
Liu
Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China; Nanjing Clinical Tech laboratories Inc., Nanjing 211000, China.
Min-Lu
ML
Cheng
Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China; Nanjing Clinical Tech laboratories Inc., Nanjing 211000, China.
Yao
Y
Wu
Yangtze River Pharmaceutical Group, Taizhou 225321, China.
Lu
L
Zheng
Yangtze River Pharmaceutical Group, Taizhou 225321, China.
Yu-Jie
YJ
Liu
Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing 210042, China. Electronic address: mpc815@163.com.
Peng-Cheng
PC
Ma
Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China; Nanjing Clinical Tech laboratories Inc., Nanjing 211000, China. Electronic address: dinglidl@hotmail.com.
Li
L
Ding
D000328:Adult; D002726:Chlorogenic Acid / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000032:analysis / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D008297:Male; D015394:Molecular Structure; D053719:Tandem Mass Spectrometry / Q000379:methods*; D013656:Taurocholic Acid / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D055815:Young Adult
D004365:Drugs, Chinese Herbal; D002726:Chlorogenic Acid; D013656:Taurocholic Acid
Chlorogenic acid; LC-MS/MS; Pharmacokinetics; Shuanghua Baihe tablets; Taurocholic acid