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Development and validation of an improved HPLC-MS/MS method for comparative pharmacokinetics of penehyclidine hydrochloride following a single intravenous or intramuscular injection
Zhao, Libo1; Zang, Yannan1,2; Sun, Yuwen1; Wei, Zhongna1; Jing, Shan1; Wang, Qian1; An, Youzhong3; Fang, Yi1; Feng, Wanyu1
关键词Penehyclidine Hydrochloride (Phc) Comparative Pharmacokinetics Bioavailability Intramuscular Injection (I.m.) Intravenous Injection (I.v.)
刊名JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES
2015-11-01
DOI10.1016/j.jchromb.2015.09.037
1004页:37-45
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Biochemical Research Methods ; Chemistry, Analytical
研究领域[WOS]Biochemistry & Molecular Biology ; Chemistry
关键词[WOS]VERAPAMIL ; PLASMA ; DRUG
英文摘要

Penehyclidine hydrochloride (PHC) is an anticholinergic drug with both antimuscarinic and antinicotinic activity. In order to compare the pharmacokinetics of two administration routes (intravenous injection (i.v.) and intramuscular injection (i.m.)) of PHC, an improved High Performance Liquid Chromatography Tandem Mass Spectrometry (HPLC-MS/MS) bioanalytical method was developed for the quantification of PHC in plasma and urine using verapamil as the internal standard (I.S.). Chromatography was performed using a Thermo Hypersil GOLD column (30 mm x 2.1 mm, 3 mu.m), with a gradient elution of 1 parts per thousand. formic acid-10 mmol/L ammonium acetate and acetonitrile at 0.3 mL/min. Detection and quantitation were performed by electrospray ionization (ESI) and multiple reaction monitoring (MRM) in the positive ion mode. The most intense [M + H](+) MRM transition of PHC at m/z 316.2 -> 128.3 was used for PHC quantitation, and the transition at m/z 454.6 -> 303.2 was used to monitor I.S. The lower limit of quantification (LLOQ) was 0.05 ng/mL. The intraday precision was <6.71% and the interday precision was <11.69%. The pharmacokinetic parameters of i.v. and i.m. administration routes were as follows (i.v. vs i.m.): t(1/2) 15.73 vs 17.24h, T-max 0.06 vs 0.26 h, AUC(0-t) 69.35 vs 67.90 h ng/mL, AUC(0-inf) 78.24 vs 79.67 h ng/mL, C-max 37.5 vs 9.1 ng/mL, Ae(0-24h) 22.7 vs 25.21 mu g. There were no significant differences between parameters t(1/2) and AUC (P > 0.05), but significant differences were observed in C-max, T-max and Ae(0-24h) between the two administration routes (P < 0.05). The mean absolute bioavailability of the i.m. administration route was 98.4% (95% confidence interval, 93.4-103.6%). Safety results showed that PHC appeared to be well tolerated in both i.v. and i.m. administration routes and pharmacokinetic results showed that PHC was nearly completely absorbed via i.m. administration route. (C) 2015 Elsevier B.V. All rights reserved.

语种英语
WOS记录号WOS:000364246300006
引用统计
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/53286
专题北京大学第二临床医学院_药剂科
北京大学第二临床医学院_重症医学科
作者单位1.Peking Univ, Dept Pharm, Peoples Hosp, Beijing 100044, Peoples R China
2.Peking Univ, Hlth Sci Ctr, Sch Pharmaceut Sci, Dept Pharm Adm & Clin Pharm, Beijing 100191, Peoples R China
3.Peking Univ, Dept Crit Care Med, Peoples Hosp, Beijing 100044, Peoples R China
推荐引用方式
GB/T 7714
Zhao, Libo,Zang, Yannan,Sun, Yuwen,et al. Development and validation of an improved HPLC-MS/MS method for comparative pharmacokinetics of penehyclidine hydrochloride following a single intravenous or intramuscular injection[J]. JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES,2015,1004:37-45.
APA Zhao, Libo.,Zang, Yannan.,Sun, Yuwen.,Wei, Zhongna.,Jing, Shan.,...&Feng, Wanyu.(2015).Development and validation of an improved HPLC-MS/MS method for comparative pharmacokinetics of penehyclidine hydrochloride following a single intravenous or intramuscular injection.JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES,1004,37-45.
MLA Zhao, Libo,et al."Development and validation of an improved HPLC-MS/MS method for comparative pharmacokinetics of penehyclidine hydrochloride following a single intravenous or intramuscular injection".JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES 1004(2015):37-45.
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