快速灵敏的HPLC方法检测人血浆中贝凡洛尔的浓度

摘要

Objective: To establish a HPLC method for determination of bevantolol in human plasma. Meth-ods: Liquid-liquid extraction was adopted after the addition of bevantolol and propranolol (an internal standard) in-to the blank plasma. The analysis involved a Plastisil ODS (250 mm×4.6 mm, 5 μm) column. The mobile phase rnconsisted of acetonitrile:10 mmol methanoic acid amine water solution (including 0.2% formic acid) (35: 65); the flow rate was 1 mL·min~(-1). The detect wavelength was 280 nm, and the column temperature was set at 40 ℃. Results:The peak area of bevantolol in plasma showed good linearity within the range of 15.5～1 984 ng·mL~(-1), and r~2 = 0.999 9. The LLOQ of bevantolol in plasma was 15.5 ng·mL~(-1). The extracted recovery was > 86% ;the relative recovery was 94%～98% ; the intra-and inter-day RSD were < 15%. Conclusion:This method is sensitive, simple and accurate;it can be used for determination of bevantolol plasma concentration and its pharmacokinetic rnand bioequivalence study.%目的:建立高效液相色谱法测定人血浆中贝凡洛尔的浓度.方法:空白血浆加贝凡洛尔和内标普萘洛尔,液液萃取法进行提取,然后用HPLC进行分析.采用Plastisil ODS柱(250 mm×4.6 mm,5μm),流动相为乙腈-10 mmol甲酸胺水溶液(含0.2%甲酸)(35:65),流速为1 mL·min~(-1),检测波长为280nm,柱温40 ℃,进样量为20μL.结果:本方法线性范围是15.5～1984 ng·mL~(-1),r~2=0.999 9,最小检出浓度(LLOQ)为15.5 ng·mL~(-1),绝对回收率均在86%以上,相对回收率在94%～98%之间,日内、日间RSD均小于15%.结论:本方法经济、简便、灵敏,适用于贝凡洛尔血药浓度检测和药动学研究.