HPLC法测定小儿氨酚烷胺颗粒中马来酸氯苯那敏的含量

Determination of Chlorphenamine Maleate in Pediatric Paracetamol and Amantadine Hydrochloride Granules by HPLC

目的:优化HPLC法,测定小儿氨酚烷胺颗粒中马来酸氯苯那敏的含量。方法:采用Diamonsil C18(4.6 mm×200 mm,5μm)色谱柱,以乙腈-0.03 mol.L-1磷酸氢二铵溶液(用磷酸调pH 3.5～5.0)(28∶72)为流动相,流速1.0 mL·min-1,检测波长210 nm,柱温30℃,进样量20μL。结果:马来酸氯苯那敏在0.076～1.532μg范围内线性良好(γ=0.999 9),平均回收率为99.0%。结论:该方法操作简单,重现性好,测定结果准确,可作为该制剂质量控制的方法。

Objective： To optimize the method of determination chlorphenamine maleate in pediatric paracetamol and amantadine hydrochloride by HPLC. Methods： The analytical column was Diamonsil Cl8 and the mobile phase consisted of aeetonitrile -0. 03 mol· L-j ammonium dibasic phosphate （adjust pH to 3.5-5.0） （28： 72） at a flow rate of 1.0 mL min^-1 The detection wavelength was 210 nm and sample size was 20 p,L. Results： There was a good linear relationship at 0. 076 - 1. 532 txg. The average recoveries of i chlorphenamine maleate was 99. 0%. Conclusion： The method was simple, accurate and reproducible, it can be used for the quality control of chlorphenamine maleate.