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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,5μm)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2.03～101.4μg.mL-1(r=0.9998);马来酸氯苯那敏的线性范围为1～50μg.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 a HPLC method for simultaneous determination of aminophylline and chlorphenamine maleate in Shunqi Sputum and its granules for the purpose of controlling the quality of Shunqi Sputum Films and Shunqi Sputum Granules. METHODS: The mobile phase consisted of methanol-0.05 mol. L-1 sodium phosphate monobasic (40:60, adjusted to pH 3.5 with phosphoric acid) at a flow rate of 1.0 mL.min-1 using a C18 (150 mm × 4.6 mm, , Detection wavelength 275 nm (theophylline), 264 nm (chlorpheniramine maleate). Results: The linear range of theophylline was 2.03 ~ 101.4μg.mL-1 (r = 0.9998). The linear range of chlorphenamine maleate was 1 ~ 50μg.mL-1 (r = 0.9998). The average recovery of theophylline in tablets was 99.4%, RSD = 2.0%; the average recovery of chlorpheniramine maleate was 99.8%, RSD = 0.84%; the average recovery of theophylline in the granules was 101.5% , RSD = 1.6%. The average recovery of chlorpheniramine maleate was 99.9% with RSD = 0.89%. CONCLUSION: The method is simple, sensitive and accurate and suitable for the simultaneous determination of aminophylline and chlorphenamine maleate in Shun Qi Huatan tablets and granules and the quality control of the varieties.