RP-HPLC法测定人血浆中盐酸氨溴索片的浓度及其药代动力学

HPLC Determination of Ambroxol Hydrochloride in Human Plasma and Pharmacokinetics

目的 :建立测定人血浆中盐酸氨溴索浓度的方法 ,用于研究盐酸氨溴索片的药代动力学。方法 :血浆样品先经碱化 ,然后用乙酸乙酯提取 ,采用RP -HPLC法检测。以ODSC18为固定相 ,pH 7 0磷酸盐缓冲液 -甲醇(2 7∶73)为流动相 ,检测波长为 2 46nm。结果 :血浆药浓在 2 0～ 2 5 0ng·mL-1范围内峰面积与浓度呈良好的线性 ,r=0 9992 ,平均回收率为 98 98% ,日内RSD =4 5 % ,日间RSD =6 8%。用本法测定 8名健康志愿者单剂量口服盐酸氨溴索国产片和进口片的体内经时过程 ,实验数据用 3P87程序拟合求得 2种片剂药代动力学参数。结论 :该法简便、准确。测得的 2种片剂的主要药代动力学参数无显著性差异。

Objective:A RP-HPLC method was set up in order to determine ambroxol hydrochloride in human plasma.Method:The procedure involved basification of plasma and a single solvent extraction of drug from plasma into ethyl acetate.The extract was analyzed subsequently on Ultrasphere ODS column (5 μm,4 6 mm×250 mm) with pH 7 0 phosphate buffer-methanol (27∶73) as mobile phase,the detection wavelength was 246 nm.Results:The regression line was linear over the concentration range of 20～250 ng·mL -1 ( r =0 999 2),the limit of detection was 12 ng·mL -1 ,the recovery was 98 98%,the RSD of within-day and between-day was 4 5% and 6 8%,respectively.Conclusion:This method was accurate and precise,no endogenous interference was found in chromatograms of the biological samples,and it was applied to the pharmacokinetics studies of ambroxol hydrochloride in human.