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
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.