小儿氨酚黄那敏颗粒中马来酸氯苯那敏含量测定及含量均匀度研究

Content assaying and the uniformity determination of chlorphenamine maleate in child paracetamol,artificial cow-bezoar and chlorphenamine maleate granules

目的：建立HPLC法测定小儿氨酚黄那敏颗粒中的马来酸氯苯那敏含量的方法并研究其含量均匀度。方法：采用C18柱，甲醇-0．05mol／L磷酸二氯钠-三乙胺（300：700：0，25），用磷酸调节pH值至2，5为流动相，流速为1mE／min，检测波长为264nm，进样量为20μL。结果：马来酸氯苯那敏的峰面积Y对进样量X（μg）的回归曲线为：Y=7794300X＋0．1558；r=0．9996，线性范围为5．56～55．60μg／mL。结论：该方法快速简便，重现性好，适用于小儿氨酚黄那敏颗粒中的马来酸氯苯那敏的质量控制。

Objective： To establish a HPLC method for the content assaying and uniformity determination of ehlorphenaraine maleate in child paracetamol, artificial cow-bezoar and chlorphenamine maleate granules. Methods： The C18 eolunm （250 mm× 4.6 mm, 5 μm） wag used and the mobile phase was methanol-0.05 mol/L sodium dihydrogen phosphate-triethylamine （300：700：0.25）, with pH adjusted with phosphoric acid to 2.5, the flow rate of 1 mL/min and the wavelength of detection of 264 nm, and injection amount of 20 p.L. Results： Chlorphenamine maleate showed a good linear relationship in the range of 5.56 - 55.6 μg/mL, Y = 7794300X ＋ 0. 1558, r = 0.9996. Conclusions： The method is simple and accurate, and can be used to determine the content assaying of ehlorpbenamine maleate in child paraeetamol, artificial cow-bezoar and chlorphenamine maleate granules.