高效液相色谱法同时测定氨酚麻美干混悬剂中3种成分的含量和含量均匀度

Simultaneous determination of content and content uniformity of 3 compounds in paracetamol,pseadoephedrine hydrochloride and dextromethorphan hydrobromide for suspension by HPLC

目的建立HPLC法同时测定氨酚麻美干混悬剂中对乙酰氨基酚、盐酸伪麻黄碱和氢溴酸右美沙芬的含量及含量均匀度。方法采用Kromasil 100-5-C18(4.6 mm×250 mm,5 μm)色谱柱,流动相:0.05 mol·L^-1磷酸二氢钾溶液(用磷酸调节pH至3.5)-甲醇,梯度洗脱;流速:1.0 mL·min^-1;检测波长:215 nm;进样体积:10 μL;柱温:30℃。结果对乙酰氨基酚、盐酸伪麻黄碱和氢溴酸右美沙芬的线性范围分别为0.162~1.136 mg·mL^-1(r=0.9999)、15.05~105.35 μg·mL^-1(r=1.000)和5.01~35.07 μg·mL^-1(r=0.9996);高、中、低3个浓度平均回收率均>98%(n=3),RSD均<1.0%(n=3)。结论本方法准确、简便、灵敏,可同时测定氨酚麻美干混悬剂中3种成分的含量及含量均匀度,为该产品的质量控制提供参考。

Objective To establish a HPLC method to determine the content and content uniformity of paracetamol,pseudoephedrine hydrochloride and dextromethorphan hydrobromide in paracetamol,pseadoephedrine hydrochloride and dextromethorphan hydrobromide for suspension.Methods The Kromasil 100-5-C18 column (4.6 mm×250 mm,5 μm) was used with mobile phase consisting of 0.05 mol·L^-1 potassium dihydrogen phosphate solution (pH adjusted to 3.5 with phosphoric acid)-methanol,gradient elution,the flow rate at 1.0 mL·min^-1,the detection wavelength at 215 nm,injection volume at 10 μL,and the column temperature at 30℃.Results The linear ranges of paracetamol,pseudoephedrine hydrochloride and dextromethorphan hydrobromide were 0.162~1.136 mg·mL^-1 (r=0.9999),15.05~105.35 μg·mL^-1 (r=1.000) and 5.01~35.07 μg·mL^-1 (r=0.9996).The average recovery were higher than 98% (n=3),RSD were less than 1.0% (n=3),respectively.Conclusion The method is accurate,simple and sensitive,which can provide reference for the quality control.