title: LC-MS/MS determination and urinary excretion study of seven alkaloids in healthy Chinese volunteers after oral administration of Shuanghua Baihe tablets.
abstract: An LC-MS/MS method was developed and validated for the simultaneous determination of magnoflorine, berberrubine, jatrorrhizine, coptisine, epiberberine, palmatine and berberine in human urine. The sample preparation procedure involved the four-fold dilution of the urine samples with acetonitrile/water (1:3, v/v). The chromatographic separation was achieved on a Hedera ODS-2 column under gradient elution at a flow rate of 0.4 mL/min with acetonitrile and water containing 0.5% formic acid as the mobile phase. The mass detection was performed in the positive mode. Calibration curves of the seven alkaloids showed good linearity (correlation coefficients>0.9973) over their concentration ranges. To meet the requirements of urinary excretion study for each alkaloid in human, the lower limit of quantification was set at different values from 0.05063 ng/mL to 2.034 ng/mL for the seven alkaloids, respectively. The intra- and inter-batch precision and accuracy were all within ± 15%. No matrix effect was observed for the analytes. The validated method was applied to the excretion study for the seven alkaloids in healthy Chinese volunteers after oral administration of Shuanghua Baihe tablets. The average 72 h cumulative urinary excretion of magnoflorine, berberrubine, jatrorrhizine, coptisine, epiberberine, palmatine and berberine accounted for 1.81%, 0.27%, 0.29%, 0.046%, 0.027%, 0.010% and 0.021% of the respective administered dose.
authors.affiliation: Department of Pharmaceutical Analysis, China Pharmaceutical University, 24 Tongjiaxiang, Nanjing 210009, PR China; Nanjing Clinical Tech Laboratories Inc., 18 Zhilan Road, Jiangning District, Nanjing 211100, PR China.
authors.forename: Minlu
authors.initials: M
authors.lastname: Cheng
authors.affiliation: Department of Pharmaceutical Analysis, China Pharmaceutical University, 24 Tongjiaxiang, Nanjing 210009, PR China; Nanjing Clinical Tech Laboratories Inc., 18 Zhilan Road, Jiangning District, Nanjing 211100, PR China.
authors.forename: Ruijuan
authors.initials: R
authors.lastname: Liu
authors.affiliation: Department of Pharmaceutical Analysis, China Pharmaceutical University, 24 Tongjiaxiang, Nanjing 210009, PR China; Nanjing Clinical Tech Laboratories Inc., 18 Zhilan Road, Jiangning District, Nanjing 211100, PR China.
authors.forename: Yao
authors.initials: Y
authors.lastname: Wu
authors.affiliation: Department of Pharmaceutical Analysis, China Pharmaceutical University, 24 Tongjiaxiang, Nanjing 210009, PR China; Nanjing Clinical Tech Laboratories Inc., 18 Zhilan Road, Jiangning District, Nanjing 211100, PR China.
authors.forename: Pan
authors.initials: P
authors.lastname: Gu
authors.affiliation: Yangtze River Pharmaceutical Group, 1 Yangtze River South Road, Gaogang District, Taizhou, 225321, PR China.
authors.forename: Lu
authors.initials: L
authors.lastname: Zheng
authors.affiliation: Yangtze River Pharmaceutical Group, 1 Yangtze River South Road, Gaogang District, Taizhou, 225321, PR China.
authors.forename: Yujie
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, 12 Jiangwangmiao Street, Nanjing 210042, PR China. Electronic address: mpc815@163.com.
authors.forename: Pengcheng
authors.initials: P
authors.lastname: Ma
authors.affiliation: Department of Pharmaceutical Analysis, China Pharmaceutical University, 24 Tongjiaxiang, Nanjing 210009, PR China; Nanjing Clinical Tech Laboratories Inc., 18 Zhilan Road, Jiangning District, Nanjing 211100, PR China. Electronic address: dinglidl@hotmail.com.
authors.forename: Li
authors.initials: L
authors.lastname: Ding
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000470:Alkaloids / Q000008:administration & dosage* / Q000652:urine*; D044466:Asian People; D002853:Chromatography, Liquid / Q000379:methods; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000378:metabolism*; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D013607:Tablets; D053719:Tandem Mass Spectrometry / Q000379:methods*; D055815:Young Adult
chemical_list: D000470:Alkaloids; D004365:Drugs, Chinese Herbal; D013607:Tablets
keywords: Berberine; Berberrubine; LC–MS/MS; Magnoflorine; Shuanghua Baihe tablets; Urinary excretion