HPLC法测定复方氨酚葡锌片中盐酸二氧丙嗪的含量及含量均匀度

Assay and Content Uniformity of Dioxopromethazine Hydrochloride in Compound Paracetamol and Zinc Gluconate Tablets by HPLC

目的建立用HPLC法测定复方氨酚葡锌片中盐酸二氧丙嗪的含量及含量均匀度的方法。方法采用C18柱,以0.05mol·L-1醋酸铵溶液-甲醇(60∶40)为流动相;流速为1.0ml·min-1;检测波长328nm。结果盐酸二氧丙嗪在2.01μg·ml-1-50.27μg·ml-1浓度范围内与峰面积呈良好线性关系(r=0.9999),平均回收率为98.6%,RSD=1.68%(n=5)。结论方法简便,结果准确,可作为本品质量控制方法。

Objective：An HPLC method for the content and uniformity determination of dioxopromethazine hydrochloride in Compound Paracetamol and Zinc Gluconate Tablets was established. Methods：A C18 column was used as stationary phase. The mobile phase consisted of methanol-0.05mol .L^- 1 ammonium acetate（40 ： 60） with flow rate 1.0ml. min^-1 and detecting at wavelength 328nm. Results：The linear range was 2.01- 50.27μg.ml^-1（r = 0. 9999）. The mean recovery was 98.6% with RSD 1.68 % （n = 5）. Conclusion ：The methods is simple and accurate and could be used for quality control of Compound Paracetamol and Zinc Gluconate Tablets.