多波长高效液相色谱法同时测定复方氨酚那敏颗粒中三组分含量

Simultaneous Determination of 3 Kinds of Main Component in Compound Paracetamol and Chlorphenamine Maleate Granules by Multi- Wavelength HPLC

目的建立同时测定复方氨酚那敏颗粒中对乙酰氨基酚、马来酸氯苯那敏和咖啡因三主成分含量的多波长高效液相色谱(HPLC)法。方法以Agilent Eclipse XDB-C18柱(250 mm×4.6 mm,5μm)为色谱柱,柱温为35℃,流动相为甲醇-0.025 mol/L磷酸二氢钾(磷酸调p H至3.2)梯度洗脱,流速为1.0 m L/min,检测波长为210 nm(咖啡因)、262 nm(马来酸氯苯那敏)、273 nm(对乙酰氨基酚)。结果建立了同时测定复方氨酚那敏颗粒中3种主成分定量的方法。结论该方法将以前2个不同流动相2个系统测定3种成分的方法简化为1个流动相的系统中,用多波长HPLC法1次测定3种成分,操作简单,结果准确,可用于复方氨酚那敏颗粒的质量控制。

Objective To establish a multi- wavelength high performance liquid chromatography（HPLC） method for simultaneously deter- mining the contents of paracetamol, chlorphenamine maleate and caffeine in Compound Paracetamol and Chlorphenamine Maleate Gran- ules. Methods The HPLC gradient elution method was adopted with the Agilent Eclipse XDB-C18 column（250 nm×4.6 mm,5 μm） as the chromatographic column,the column temperature was 35 ℃ and the flow rate of 1.0 mL/min,methanol-0. 025 mol/L potassi- um dihydrogen phosphate （adjusting pH to 3.2 with phosphoric acid） as the mobile phase,the detective wavelengths were respectively 210 nm for caffeine,262 nm for chlorphenamine maleate and 273 nm for paracetamol. Results The method for simultaneously deter- mining 3 main components in Compound Paracetamol and Chlorphenamine Maleate Granules was established. Conclusion This method simplifies the previous method of 2 different mobile phases and 2 systems for determining 3 components to 1 mobile phase system, can simultaneously determine 3 kinds of main component,is simple to operate and accurate in the detection results,and can be used for the quality control of Compound Paracetamol and Chlorphenamine Maleate Granules.