高效液相色谱法测定磷酸苯丙哌林含量及有关物质

HPLC determination of benproperine phosphate and its related substances

目的:采用高效液相色谱法测定磷酸苯丙哌林原料、口服液的含量并建立有关物质的检查方法。方法:采用 C_(18)色谱柱(4.6mm×150mm,5μm);以甲醇-醋酸铵缓冲溶液(62:38)为流动相,流速:1.0mL·min^(-1);检测波长:270nm;柱温:室温;进样量:20μL。结果:在该色谱条件下,磷酸苯丙哌林浓度在0.1～1.0mg·mL^(-1)范围内呈良好的线性关系,r=0.9992,平均回收率为98.4%(n=9),检测限为4μg·L^(-1)。结论:所建立的方法灵敏、准确、简便,可作为磷酸苯丙哌林含量测定方法及有关物质的检查方法。

Objective： To establish an HPLC method for the determination of benproperine phosphate, its oral liquid and related substances. Method： The separation and analysis was performed on a C18 column （4. 6 mm × 150mm, 5 μm）. The mobile phase consisted of methanol -ammonia acetate buffer solution （62： 38）. The flow rate was 1.0 mL · min^-1. The detection wavelength was set at 270 nm and the chromatography was operated at room temperature. Loaded volume was 20 μL. Results： A good linear relationship was obtained in the benproperine phosphate concentration of 0. 1 - 1.0 mg · mL^-1, r =0. 9992. The average recovery was 98.4% （n =9）. The limit of detection was 4μg· L^-1. Conclusion： The proposed method is sensitive, accurate and simple, and can be used for the determination of benpropefine phosphate, its oral liquid and related substances.