复方盐酸曲马多片及有关物质的HPLC测定

Determination of Compound Tramadol Hydrochloride Tablets and Its Related Substances by HPLC

建立了HPLC法测定复方盐酸曲马多片的含量及有关物质。采用C18柱,流动相为0.05mol/L磷酸二氢钾-甲醇-三乙胺(65∶35∶0.5,磷酸调至pH2.7),流速1.0ml/min,检测波长215nm。盐酸曲马多和对乙酰氨基酚分别在8～80、72～720μg/ml范围内线性关系良好。平均回收率分别为101.4%和99.4%。

A HPLC method for the determination of compound tramadol hydrochloride tablets and its related substances was established. A C 18 column was used with the mobile phase of 0.05mol/L KH 2 PO 4 -methanol-triethylamine (65∶35∶0.5, pH adjusted to 2.7 with phosphoric acid).The flow rate was 1.0ml/min and the detection wave- length was 215nm.The calibration curve of tramadol hydrochloride and paracetamol were linear in the ranges of 8- 80 and 72-720μg/ml, respectively. The average recovery were 101.4% and 99.4%, respectively.