HPLC同时测定克咳宁片中盐酸二氧丙嗪和磷酸苯丙哌林的含量

HPLC simultaneous determination of dioxopromethazine hydrochloride and benproperine phosphate in Kekening tablets

目的:建立克咳宁片的HPLC含量测定方法。方法:使用依利特C18(250mm×4.6mm,5μm)色谱柱,以甲醇-0.1mol.L-1醋酸铵溶液-三乙胺(65∶35∶0.3,用冰醋酸调节pH至6.0)为流动相,检测波长270nm。结果:盐酸二氧丙嗪进样量在1.1～5.4μg范围内(r=0.9998)、磷酸苯丙哌林进样量在2.1～10.5μg范围内(r=0.9999)线性关系良好;2组分低、中、高3种浓度的平均回收率(n=3)分别为99.4%,100.9%,100.4%和98.6%,101.6%,102.1%;RSD分别为2.6%,2.9%,2.2%和2.4%,2.8%,2.0%。结论:所建立的方法可准确、快速地进行定性、定量检测,可用于该制剂的质量控制。

Objective：To establish an HPLC method for assay of Kekening tablets.Methods：Elite C18（250 mm×4.6 mm,5 μm）column was used,with mobile phase consisting of methanol-0.1 mol·L-1 ammonium acetate solution-triethyl amine（65∶35∶0.3,adjusted to pH 6.0 with glacial acetic acid）and detection wavelength of 270 nm.Results：Dioxopromethazine hydrochloride and benproperine phosphate showed good linear relationship at a range of 1.1-5.4 μg（r=0.9998）and 2.1-10.5 μg（r=0.9999）,respectively,the average recoveries for two ingredients at low,medium and high concentration were 99.4%,100.9%,100.4% and 98.6%,101.6%,102.1%,respectively,and RSD were 2.6%,2.9%,2.2% and 2.4%,2.8%,2.0%,respectively.Conclusion：The method is accurate and fast,and can be used for the quality control of Kekening tablets.