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目的:建立以高效液相色谱法同时测定扑地麻滴鼻液中盐酸麻黄碱、马来酸氯苯那敏、地塞米松磷酸钠含量的方法。方法:色谱柱为ShimpackODS,流动相为甲醇-50mmol.L-1磷酸二氢钾缓冲液(45∶55),检测波长为240nm,流速为1.0mL.min-1,柱温为室温。结果:盐酸麻黄碱、马来酸氯苯那敏、地塞米松磷酸钠检测浓度分别在100~400(r=0.9993)、50~200(r=0.9997)、10~40(r=0.9998)μg.mL-1范围内与峰面积积分值线性关系良好,平均回收率分别为(99.59±0.41)%、(100.25±0.61)%、(100.70±1.66)%。结论:本方法对3组分和附加剂分离效果好,精密度和回收率高,可用于该药的含量测定。
Objective: To establish a method for the simultaneous determination of ephedrine hydrochloride, chlorpheniramine maleate and dexamethasone sodium phosphate in Putima nasal drops by high performance liquid chromatography. Methods: The chromatographic column was Shimpack ODS. The mobile phase consisted of methanol-50mmol.L-1 potassium dihydrogen phosphate buffer (45:55), the detection wavelength was 240nm, the flow rate was 1.0mL.min-1 and the column temperature was room temperature. Results: The concentrations of ephedrine hydrochloride, chlorpheniramine maleate and dexamethasone sodium phosphate were 100 ~ 400 (r = 0.9993), 50 ~ 200 (r = 0.9997), 10 ~ 40 (mL) -1. The average recoveries were (99.59 ± 0.41)%, (100.25 ± 0.61)% and (100.70 ± 1.66)%, respectively. Conclusion: The method has good separation effect on 3 components and additives, high precision and high recovery, and can be used for the determination of this medicine.