HPLC法测定体液中氨溴索浓度及其药代动力学参数

建立了 HPLC测定人血浆及尿中盐酸氨溴索含量的方法 :Hypersill C18柱 (4.6mm× 2 50 mm,5μm) ,乙腈 -甲醇 - 0 .0 1 mol/L磷酸盐缓冲液 -四氢呋喃 (35∶ 35∶ 2 7.5∶ 2 .5,V/V)为流动相 ,流速 1 .5ml/min,检测波长 2 4 2 nm。结果表明 :最低检测浓度为 5ng/ml,血药浓度在 1 0～ 32 0 ng/ml范围内线性良好 ,尿药浓度在 0 .2 5～ 8.0μg/ml范围内线性良好 ,氨溴索生物半衰期为 (4.2 1± 0 .93) h。

Determination of ambroxol hydrochloride in human plasma and urine and pharmacokinetic parameter by HPLC

An HPLC method of determination of ambroxol hydrochloride in human plasma and urine was established. The analytical column was Hypersil C 18 (4 6mm×250mm, 5 m). The mobile phase was the mixture of acetonitrile methanol 0 01mol/L phosphate buffer tetrahydrofuran(35∶35∶27 5∶2 5, V/V). The flow rate was 1 5ml/min. The detector set at 242nm. The linear range of plasma concentration was 10～320ng/ml, that of urine concentration was 0 25～8 0μg/ml. A single dose of ambroxol hydrochloride capsule was taken orally by eight healthy volunteers. The level of anbroxol in plasma and urine was determined with this method. The results showed the biological half life of ambroxol was 4 21h.