标题：Development and Validation of a HPLC-MS/MS Method for the Determination of Azelnidipine in Human Plasma and Application to a Bioequivalence Study
作者：Zhang, Yunyun; Chen, Xuwang; Yuan, Guiyan; Zhang, Rui; Wang, Benjie; Guo, Ruichen
作者机构：[Zhang, Yunyun] Shandong Univ, Sch Med, Dept Pharmacol, 44 Wenhua West Rd, Jinan 250012, Shandong, Peoples R China.; [Zhang, Yunyun; Chen, Xuwang; Y 更多
通讯作者地址：[Guo, RC]Shandong Univ, Qilu Hosp, Inst Clin Pharmacol, 107 Wenhua West Rd, Jinan 250012, Shandong, Peoples R China.
来源：LATIN AMERICAN JOURNAL OF PHARMACY
关键词：azelnidipine; bioequivalence evaluation; LC-MS/MS; quantitative analysis
摘要：A rapid, sensitive and environmental-friendly HPLC-MS/MS method was established and validated to detect azelnidipine in human plasma with a congener drug nicardipine as internal standard. Azelnidipine and nicardipine in plasma samples were extracted by protein precipitation, separated by isocratic elution on a C-18 column and monitored with multiple reactive monitoring (MRM) mode within the linear range of 0.1000-29.92ng/mL. The method was successfully applied to a bioequivalence evaluation of test and reference azelnidipine tablets in 24 healthy Chinese male volunteers with the parameters: C-max 7.592 +/- 3.682 and 7.588 +/- 5.232ng/mL; AUC(0.96) 62.616 +/- 31.497 and 58.826 +/- 37.802 ng.h/mL; AUC(0-infinity) 64.886 +/- 32.228 and 61.675 +/- 38.269 ng.h/mL, respectively. The relative bioavailability was 113.7 +/- 29.4% and the 90% confidence intervals for the mean AUC(0-96), AUC(0-infinity) and C-max ratios (test/reference) were 99.5-121.2%, 98.2-119.1% and 95.6-123.3%, respectively.