柳酚咖敏片含量及有关物质的UFLC测定

Determination of Salicylamide Paracetamol Caffeine Phenylephrine and Brompheniramine Tablets and Its Relative Substances by UFLC

目的建立UFLC法测定柳酚咖敏片中盐酸去氧肾上腺素、对乙酰氨基酚、无水咖啡因、水杨酰胺和马来酸溴苯那敏的含量及有关物质。方法采用Kinetex C18色谱柱,以0.5%三乙胺溶液（磷酸调节pH至3.0）和甲醇为流动相,梯度洗脱,流速为1mL.min-1。结果盐酸去氧肾上腺素、马来酸溴苯那敏、咖啡因对乙酰氨基酚和水杨酰胺分别在0.10~10.33,0.05~4.82,0.04~4.10,0.30~30.50和0.30~30.44μg范围内线性关系良好。各组分平均回收率为99.7%~100.7%,RSD为0.24%~0.67%（n=9）。结论该方法简单、快速、准确,可用于柳酚咖敏片的含量及有关物质检测。

Objective To establish a method to determine Salicylamide Paracetamol Caffeine Phenylephrine and Brompheniramine Tablets and its relative substances by UFLC.Methods The method was achieved on a Kinetex C18 column utilizing a mobile phase of methanol-0.5% triethamide solution by linear gradient elution at a flow rate of 1mL·min-1.Results Phenylephrine hydrochloride,brompheniramine maleate,caffeine,paracetamol and salicylamide were linear in the ranges of 0.10~10.33,0.05~4.82,0.04~4.10,0.30~30.50,0.30~30.44μg,respectively.The recoveries were 99.7%~100.7% with relative standard derivations（RSD） of 0.24%~0.67%（n=9）.Conclusion The method is simple,rapid and accurate.It can be used for quality control of Salicylamide Paracetamol Caffeine Phenylephrine and Brompheniramine Tablets.