盐酸氯环利嗪质量标准研究

目的: 改进盐酸氯环利嗪含量测定方法，建立盐酸氯环利嗪残留溶剂测定法。方法: 采用不使用汞盐的电位滴定法测定盐酸氯环利嗪的含量、气相色谱法测定盐酸氯环利嗪的残留溶剂。结果: 含量测定中盐酸氯环利嗪在0.16～0.24g范围内线性关系良好(r=0.999 9)，平均回收率为99.7%，RSD为0.3%(n=9)；残留溶剂测定中乙醇与乙酸乙酯能得到有效分离，在所考察的浓度范围内线性关系良好（相关系数分别为0.999 3，0.999 8），平均回收率（n=9）分别为101.3%、100.9%。结论: 所建方法专属性强，准确度高，可用于盐酸氯环利嗪的质量控制。

Study on Quality Standard for Chlorcyclizine Hydrochloride

Objective: To improve the determination method of Chlorcyclizine Hydrochloride and establish a method for the determination of residual solvents in Chlorcyclizine Hydrochloride. Methods: Potentiometric titration with no mercuric acetate was used to determine the content of Chlorcyclizine Hydrochloride and GC method to determine residual solvents in it.Results: The contents of Chlorcyclizine Hydrochloride was linear in the ranges of 0.16~0.24 g(r=0.999 9), the average recovery was 99.7% with RSD of 0.3% (n=9). Alcohol and ethyl acetate were separated completely, the calibration curves showed good linear relationships (r=0.999 1, 0.999 9), the average recoveries were 101.3% and 100.9%(n=9), respectively.Conclusion: The improved method is specific and accurate. It can be used to control the quality of Chlorcyclizine Hydrochloride.