HPLC法同时测定顺气化痰片及顺气化痰颗粒中氨茶碱和马来酸氯苯那敏的含量

目的: 为控制顺气化痰片及顺气化痰颗粒质量,建立高效液相色谱法同时测定顺气化痰片及其颗粒剂中氨茶碱和马来酸氯苯那敏的含量。 方法: 采用C₁₈(150 mm×4.6 mm,5 μm)色谱柱,流动相为甲醇-0.05 mol·L^-1磷酸二氢钠(40∶60,用磷酸调节pH 3.5),流速1.0 mL·min^-1,检测波长275 nm(茶碱)、264 nm(马来酸氯苯那敏)。 结果: 茶碱的线性范围为2.03~101.4 μg·mL^-1(r=0.9998);马来酸氯苯那敏的线性范围为1~50 μg·mL^-1(r=0.9998)。片剂中茶碱的平均回收率为99.4%,RSD=2.0%;马来酸氯苯那敏的平均回收率为99.8%,RSD=0.84%;颗粒剂中茶碱的平均回收率为101.5%,RSD=1.6%;马来酸氯苯那敏的平均回收率为99.9%,RSD=0.89%。 结论: 该方法简便、灵敏、准确,适用于顺气化痰片剂及颗粒剂中氨茶碱和马来酸氯苯那敏的同时测定及该品种的质量控制。

Objective: To establish an HPLC method for simultaneous determination of theophylline and chlorphenamine maleate in Shunqi Huatan tablets and granules. Method: The samples were separated by a C₁₈ column (150 mm×4.6 mm,5 μm) with methanol-0.05 mol·L^-1NaH₂ PO₄(40∶60,adjusted pH to 3.5 with H₃PO₄) as mobile phase and detected at 272 nm for theophylline and 264 nm for chlorphenamine maleate with a flow rate of 1.0 mL·min^-1. Results: The method had good linear relationship in the ranges of 2.03-101.4 μg·mL^-1 for theophylline (r=0.9998) and 1-50 μg·mL^-1 for chlorphenamine maleate (r=0.9998).The average recovery of theophylline was 99.4%(RSD=2.0%),of chlorphenamine maleate was 99.8%(RSD=0.84%) in tablets.While the average recovery of theophylline was 101.5%(RSD=1.6%),of chlorphenamine maleate was 99.9% (RSD=0.89%) in granules. Conclusion: This method is simple,fast,accurate,and can be used to simultaneously determine content of aminophylline and chlorphenamine maleate in Shunqi Huatan tablets and granules.

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