标题:Bioequivalence of nifedipine softgel and capsule in healthy Chinese volunteers by liquid chromatography-mass spectrometry
作者:Zhang, Jing; Song, Hao-Jing; Bu, Fan-Long; Wei, Chun-Min; Yuan, Gui-Yan; Liu, Xiao-Yan; Wang, Ben-Jie; Guo, Rui-Chen
作者机构:[Zhang, Jing; Song, Hao-Jing; Bu, Fan-Long; Wei, Chun-Min; Yuan, Gui-Yan; Liu, Xiao-Yan; Wang, Ben-Jie; Guo, Rui-Chen] Shandong Univ, Qilu Hosp, Inst 更多
通讯作者:Guo, RC
通讯作者地址:[Guo, RC]Shandong Univ, Qilu Hosp, Inst Clin Pharmacol, Jinan 250012, Peoples R China.
来源:EUROPEAN JOURNAL OF DRUG METABOLISM AND PHARMACOKINETICS
出版年:2010
卷:35
期:1-2
页码:67-73
DOI:10.1007/s13318-010-0010-0
关键词:Nifedipine; Bioequivalence; LC/MS; Pharmacokinetics
摘要:The study aimed to compare and evaluate the bioequivalence of Calcigard-10 softgel and Adalat (R) 10 capsule in healthy Chinese volunteers in a randomized, two-way cross over study design with a washout period of 7 days. A sensitive and reproducible electro-spray ionization liquid chromatography-mass spectrometry (ESI-LC-MS) assay was developed and validated to determine nifedipine in human plasma using nitrendipine as internal standard. Nifedipine and nitrendipine were extracted from plasma using liquid-liquid extraction with methylene chloride as extraction solvent. The separation was performed by a Diamonsil ODS column (150 x 4.6 mm, 5 mu m). The mobile phase was consisted of acetonitrile-5 mM ammonium acetate (52:48, v/v), delivered at flow rate of 1 mL/min. The 90% confidence intervals for the ratio values of logarithmic transformed C(max) and AUC were calculated to evaluate the bioequivalence of two preparations. The values of C(max) (92.3-112.7%), AUC(0-t) (84.5-95.1%) and AUC(0-inf) (84.4-95.5%) are within the interval criterion of 70-143% for C(max) and 80-125% for AUC. The Calcigard-10 softgel and Adalat (R) 10 capsule are bioequivalent.
收录类别:SCOPUS;SCIE
WOS核心被引频次:5
Scopus被引频次:1
资源类型:期刊论文
原文链接:https://www.scopus.com/inward/record.uri?eid=2-s2.0-78149413749&doi=10.1007%2fs13318-010-0010-0&partnerID=40&md5=466bfa0524bb49eb9f747f4d79adf4fc
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