中文摘要：

目的 建立氟比洛芬对映体选择性高效液相-质谱分析方法,用于其贴剂经兔皮肤吸收的药物动力学研究。方法 手性色谱柱：大赛璐Chiralpak AD-RH（4.0 mm×150 mm,5 μm）;内标：酮洛芬;流动相：乙腈-2 mmol·L-1 pH 5.3醋酸铵溶液（50∶50,V/V）。血浆中的药物和内标以甲基叔丁基醚提取。结果 氟比洛芬对映体在2.0~1 000 ng·mL-1内,主药与内标峰面积比与血浆浓度呈良好线性关系,定量下限浓度 2.0 ng·mL-1。检测方法日内平均回收率98.5%~103.8％,RSD〈6.0%。在连续5 d内测定高、中、低 3个对映体浓度的血浆样品,日内精密度RSD〈5.8%,日间精密度RSD〈5.0%。结论 建立的对映体选择性高效液相-质谱分析方法灵敏、准确、精密,成功应用于兔血浆中氟比洛芬对映体的定量测定。

英文摘要：

Objective To develop an enantioselective HPLC-MS-MS method for the pharmacokinetic study of flurbiprofen transdermal patches. Methods The analyte and internal standard, ketoprofen, were extracted from plasma by methyl tert-butyl ether, analyzed on a Chiralpak AD-RH column（4.0 mm×150 mm,5 μm）with mobile phase consisting of acetonitrile-ammonium acetate buffer solution（2 mmol·L-1 pH 5.3, 50∶50, V/V）, and detected with UV detector at 273 nm. Results The assay was linear over the concentration range of 2.0-1 000 ng·mL-1 and the intra- and inter-day precision over this range were not more than 5.8%. The limit of quantification in plasma was 2.0 ng·mL-1. Conclusion The method established here is accurate, precise, rapid, sensitive, and successfully applied to the enantioselective determination of flurbiprofen in the pharmacokinetic study of flurbiprofen transdermal patches in rabbits.