HPLC法同时测定复方乳酸依沙吖啶溶液中两种组分的含量

Simultaneous determination of two components in complex ethacridine lactate solution by HPLC

目的：建立HPLC法同时测定复方乳酸依沙吖啶溶液中乳酸依沙吖啶和盐酸苯海拉明的含量。方法：色谱柱为Luna氰基柱（4.6 mm×250 mm，5μm）；流动相为乙腈-水-三乙胺（50∶50∶0.5）；流速1.0 mL·min-1；柱温30℃；检测波长230 nm；进样量20μL。结果：乳酸依沙吖啶和盐酸苯海拉明与二苯酮分离良好。乳酸依沙吖啶在0.6012~1.4030 mg·mL-1范围内线性关系良好（r=0.9994），盐酸苯海拉明在0.1487~0.3469 mg·mL-1范围内线性关系良好（r=0.9999），依沙吖啶和苯海拉明的平均回收率分别为99.91%、99.73%，RSD分别为1.06%（n=9）、1.10%（n=9）。结论：本方法简便准确，快速可靠，可用于复方乳酸依沙吖啶溶液的含量测定和质量控制。

Objective： To establish the HPLC method for simultaneous determination of ethacridine lactate and benzhydramine hydrochloride in complex ethacridine lactate solution. Methods： The extract was separated by Luna CN column （4.6 mm × 250 mm, 5μm ）, and the mobile phase was consisted of acetonitrile-water-triethylamine （50：50：0.5） with the lfow rate of 1.0 mL·min-1. The column temperature was 30℃. The detection wavelength was 230 nm and the injection volume was 20 μL. Results：The calibration curves of ethacridine lactate and benzhydramine hydrochloride were linear in the range of 0.601 2-1.403 0 mg·mL-1 （r = 0.999 4） and 0.148 7 - 0.346 9 mg· mL-1 （r = 0.999 9）, respectively. The average recovery of ethacridine lactate was 99.91%with RSD of 1.06%（n=9）. The average recovery of benzhydramine hydrochloride was 99.73%with RSD of 1.10%（n=9）. Conclusion：The method is simple, accurate and reliable. It can be used as the quality control of complex ethacridine lactate solution.