高效液相色谱法测定羚黄氨咖敏片中马来酸氯苯那敏、对乙酰氨基酚、咖啡因的含量

HPLC Determination of Chlorpheniramine Maleate, Paracetamol and Caffeine in Linghuang'anjiamin Tablets

目的 建立羚黄氨咖敏片中马来酸氯苯那敏、对乙酰氨基酚、咖啡因的高效液相色谱测定方法.方法 采用Hypersil-ODS柱,甲醇-0.05 mol/L磷酸二氢钾溶液（25：75,0.5%磷酸调节pH 3.0）为流动相,流速1.0 mg/min,检测波长216 nm.结果 马来酸氯苯那敏线性范围1.20～2.80 mg/L,平均回收率为97.90%,RSD为1.52%;对乙酰氨基酚150.00～350.00 mg/L,平均回收率为100.21%,RSD为0.92%;咖啡因9.00～21.00 mg/L,平均回收率为101.46%,RSD为0.90%.结论 本方法简便、结果准确,可用于制剂的含量测定和质量控制.

Objective To establish a methods of HPLC （high performance liquid chromatography） to the determination of chlorpheniramine maleate, paracetamol and caffeine in Linghuang＇anjiamin tablets. Methods Hypersil-ODS column mobile phase composed of methanol and 0.05 mol/L of KH2PO4 （25：75, adjusted to pH3.0 with 0.5% pf H3PO4 ） was adopted. The flow rate was 1.0 ml/min. The UV detection wavelength was 216 nm. Results The standard curve of chlorpheniramine maleate was hnear over a range of 1.20 -2.80 mg/L. The average recovery was 97.90% with a RSD of 1.52%. The standard curve of paracetamol was linear over a range of 150.00 -350.00 mg/L. The average recovery was 100.21% with a RSD of 0.92%. The standard curve of caffeine was linear over a ranger of 9.00 - 21.00 mg/L. The average recovery was 101.46% with a RSD of 0.90%. Conclusion This method of HPLC is found to be simple and accurate, and it could be used for the analysis of the agent concentration and for the quality control.