HPLC法测定复方氨肽素片中马来酸氯苯那敏的含量及含量均匀度

目的:建立HPLC法测定复方氨肽素片中马来酸氯苯那敏的含量及含量均匀度。方法:色谱柱为Welch Material XB-C18(4.6 mm×150 mm,5μm);流动相为0.05 mol.L-1磷酸二氢钠溶液(用三乙胺调节pH值至3.0±0.1)-甲醇(60∶40);检测波长265 nm。结果:马来酸氯苯那敏进样量在0.107 7～0.646 2μg范围内与峰面积线性关系良好(r=1.000 0);平均回收率为99.06%,98.83%,99.14%;RSD为0.93%,0.57%,0.46%(n=3);精密度、重现性良好。结论:所建方法快速准确,灵敏度高,结果可靠,为本品质量标准的修订和提高提供了基础。

Content Determination and Content Uniformity Test of Chlorphenamine Maleate in Compound Amino-polypeptide Tablets by HPLC

Objective： To establish a method for determining the content and content uniformity of chlorphenamine maleate in Compound Amino-polypeptide Tablets by HPLC. Methods： The Welch Material column （XB-CI8, 4. 6 m×150mm,5μm）was used; the mobile phase was 0. 05 mol · L- 1 sodium dihydrogen phosphate solution （adjust pH to 3.0 ＋ 0. 1 by triethylamine）-methanol （60： 40） ; the detective wavelength was 265 nm. Results： The calibration curves showed good linear over the range of 0. 107 7 -0. 646 2 txg, r = 1. 000 0; the average recovery rates were 99. 06% , 98.83% , 99. 14% , RSD were 0. 93% , 0. 57% , 0.46% （n =3）. Conclusion： The established method is rapid, accurate and sensitive for testing content and content uniformity of chlorphenamine Maleate in compound amino-polypeptide tablets.