标题：An Accurate, Rapid and Sensitive LC-MS-MS Method for Quantification of Rosuvastatin in Human Plasma: Application to a Bioequivalence Study
作者：Wang, Yanyan; Liu, Xianyong; Yuan, Guiyan; Li, Rong; Liang, Xinyue; Li, Pingli; Wang, Xiaolu; Li, Wenlong; Wang, Benjie; Guo, Ruiche 更多 作者机构：[Wang, Yanyan; Yuan, Guiyan; Li, Rong; Liang, Xinyue; Li, Pingli; Wang, Xiaolu; Li, Wenlong; Wang, Benjie; Guo, Ruichen] Shandong Univ, Qi Lu Hosp, In 更多
通讯作者地址：[Guo, RC]Shandong Univ, Qi Lu Hosp, Inst Clin Pharmacol, Jinan 250012, Peoples R China.
来源：LATIN AMERICAN JOURNAL OF PHARMACY
关键词：bioavailability; bioequivalence; LC-MS/MS; rosuvastatin
摘要：An accurate, rapid and sensitive liquid chromatography-tandem mass spectrometry method was developed for quantification of rosuvastatin in human plasma with gliclazide as internal standard. The analytes were extracted with one-step liquid-liquid extraction, separated on a C-18 column (150 x 4.6 mm, 5 mu m), and eluted with mobile phase of 0.1% formic acid-methanol (30:70, v/v). The linear range for rosuvastatin in human plasma was 0.1-60 ng/mL. The specificity, matrix effect, recovery, linearity, accuracy, precision and stability were in accordance to US Food and Drug Administration guidelines. This method was applied to bioequivalence study of rosuvastatin calcium tablets. An open-label, two-way crossover, randomized-sequence study of single-dose oral 10 mg rosuvastatin calcium tablets were conducted in healthy Chinese male volunteers; 90% confidence intervals for the mean AUC(0-t), AUC(0-infinity) and C-max ratios (test/reference) were 96.9-113.3, 95.5-112.2, and 88.2-109.8%, respectively. Two one-side t-test and analysis with 90% confidence intervals of variance for the AUC(0-t), AUC(0-infinity) and Cmax, nonparametric-test for T-max suggested the two products were bioequivalent.