HPLC法测定小儿氨酚黄那敏颗粒中马来酸氯苯那敏和对乙酰氨基酚的含量

Determination of Chlorphenamine Maleate and Paracetamol in Pediatric Paracetamol, Artificial Cow-bezoar and Chlorphenamine Maleate Granules by HPLC

目的：建立HPLC法测定小儿氨酚黄那敏颗粒中马来酸氯苯那敏和对乙酰氨基酚的含量。方法：采用C18色谱柱（150mm×4．6mm，5μm），以甲醇-0．05mol／L磷酸二氢钾溶液一三乙胺（10：90：0．02）（用磷酸调节pH至4．0）为流动相，柱温为室温，流速为1．0mL／min，检测波长为215nm，进样量为20μL.结果：线性范围分别为马来酸氯苯那敏6．09～14．21μg/mL，r=0．9999，对乙酰氨基酚17．94～41．86μg/mL，r=0．9999；平均回收率均为99．14％（n=3）。结论：此法快速、准确，可作为本品质量评价和生产工艺监控的有效方法。

Objective： To establish a HPLC method to detemaine chlorphenamine maleate and paracetamol in pediatric paraeetamol, artificial cow-bezoar and chlorphenamine maleate granules. Methods： C18 column （150 mm× 4.6 mm, 5μm） at room temperature, the mobile phase consisting of methanol-0.05 mol/L phosphate buffer-triethylamine （ 10 ： 90 ： 0.02） （ adjusted pH to 4.0 with phosphoric acid）, and flow rate 1.0 mL/min, the detection was done at wavelength 215 nm, with injection amount 20 μL. Results： The calibration curves were linear in the range of 6.09- 14.21 μg/mL （ r =0.999 9） for ehlorphenamine maleato and 17.94- 41.86 pg/mL （r = 0. 999 9） for paracetamol. The average recoveries of both ehlorphenamine maleate and paracetamol were 99.14%（ n = 3）. Conclusion： This proposed method appeared to be simple, rapid and accurate. It can be used to control the product quality and preparation process.