De Leenheer A P, Vandecasteele-Thienpont L M
J Pharm Sci. 1980 Jan;69(1):99-100. doi: 10.1002/jps.2600690130.
A specific and sensitive GLC analysis of bromhexine in human plasma is described. After addition of the internal standard and an aqueous triethanolamine solution, bromhexine is extracted at alkaline pH into n-hexane, transferred to an acidic aqueous solution, and back-extracted into n-hexane after alkalinization. Both compounds are derivatized with trifluoroacetic anhydride and quantified by GLC using , 63Ni-electron-capture detector. The method has a sensitivity of approximately 1.0 ng/ml of plasma. Linearity of plasma working curves was good. The extraction recovery from spiked plasma was 90.1 +/- 5.68% (SD). The within-run and within-day precisions (CV) were 6.0% (4.3 ng/ml, n = 8) and 8.6% (11.0 ng/ml, n = 13), respectively. The procedure was applied successfully to measurement of the plasma concentration-time profile in a human volunteer after oral drug administration.
本文描述了一种用于测定人血浆中溴己新的特异性灵敏气相色谱分析方法。加入内标和三乙醇胺水溶液后，在碱性pH条件下将溴己新萃取至正己烷中，转移至酸性水溶液中，碱化后再反萃取至正己烷中。两种化合物均用三氟乙酸酐衍生化，并使用63Ni电子捕获检测器通过气相色谱法定量。该方法对血浆的检测灵敏度约为1.0 ng/ml。血浆工作曲线的线性良好。加标血浆的萃取回收率为90.1±5.68%（标准差）。批内和日内精密度（变异系数）分别为6.0%（4.3 ng/ml，n = 8）和8.6%（11.0 ng/ml，n = 13）。该方法已成功应用于一名人类志愿者口服药物后血浆浓度-时间曲线的测定。
