摘要
目的：建立测定血浆中氨溴索浓度的反相高效液相色谱法。方法：血浆样品用乙醚提取，醚层经００１ｍｏｌ·Ｌ－１盐酸提取后进样，色谱柱为ＲｅｓｏｌｖｅＣ１８４６ｍｍ×２５０ｍｍ（５μｍ），流动相为乙腈－甲醇－００１ｍｏｌ·Ｌ－１ｐＨ７０磷酸盐缓冲液－四氢呋喃（３５０∶３５０∶２７５∶２５），流速１５ｍＬ·ｍｉｎ－１，检测波长２４２ｎｍ，外标法峰高定量。结果：本法最低检测浓度５ｎｇ·ｍＬ－１，线性范围１０～３２０ｎｇ·ｍＬ－１，回归方程为Ｈ＝２４５＋１６４Ｃ，ｒ＝０９９９５，日内ＲＳＤ为２７％～５３％，日间ＲＳＤ为３２％～８２％。结论：该法适用于盐酸氨溴索片的药代动力学研究。
Objective: A RP-HPLC method was developed for the determination of ambroxol in human plasma. Method: All samples were extracted from plasma with diethyl ether and back extraction in 001 molL-1 HCl. The analytical column was Resolve C18 (5 m,46 mm250 mm).The mobile phase consisted of acetonitrile-methanol-001 molL-1 phosphate buffer (pH 70)-tetrahydrofuran (35035027525). The flow rate was 15 mLmin-1, and the detector was set at UV 242 nm. Results: The minimal detectable plasma drug concentration was 5 ngmL-1.The calibration curve was linear in the range of 10320 ngmL-1(H=245+164C,r=09995). The RSD within day was 27%53%. The RSD between days was 32%82%. Conclusion: This method has been applied to the pharmacokinetic study after a single oral administration of 90 mg ambroxol hydrochloride tablets in 8 healthy volunteers.
出处
《药物分析杂志》
CAS
CSCD
北大核心
1999年第3期171-174,共4页
Chinese Journal of Pharmaceutical Analysis
