HPLC法测定马来酸氯苯那敏注射液的有关物质

Determination of related substances in chlorphenamine maleate injection by HPLC

目的 :建立HPLC法测定马来酸氯苯那敏注射液有关物质的方法。方法 :采用高效液相色谱法,色谱柱为C18柱(4.6 mm×250 mm,5μm);流动相为乙腈-0.857%磷酸二氢铵溶液(20∶80)(用磷酸调节p H值至3.0);流速:1.2 ml/min;检测波长:225 nm。结果 :氯苯那敏峰与杂质A、B、C、D峰之间的分离度良好,氯苯那敏及四个杂质的最小检测限分别为0.017、0.016、0.077、0.030、0.053μg/ml。结论 :该法简便、准确、专属性好、灵敏度高,可作为马来酸氯苯那敏注射液有关物质的检查方法。

Objective：To establish an HPLC method for the determination of related substances in chlorphenamine maleate injection.Methods：The HPLC was carried out on a C18 column （4.6 mmx250 mm, 5μm） with a mobile phase of acetonitrile - 0.857% of ammonium dihydrogen phosphate solution （20：80） （adjusted to pH 3.0 with phosphoric acid） at the lfow rate of 1.2 ml/min and the detected UV wavelength of 225 nm.Results： Good separation among the peaks of chlorphenamine and impurity A, B, C, D was obtained. The detection limits of chlorphenamine and 4 impurities were 0.017, 0.016, 0.077, 0.030 and 0.053μg/ml, respectively.Conclusion：This method is simple, accurate with good speciifcity and high sensitivity and can be used for the analysis of related substances in chlorphenamine maleate injection.