高效液相色谱法测定麻杏石甘口服液中盐酸麻黄碱含量的方法研究

Determination of Ephedrine hydrochloride in Maxingshigan Oral Solution by HPLC

为完善麻杏石甘口服液质量标准,采用高效液相色谱法对麻杏石甘口服液中盐酸麻黄碱的含量测定方法进行了研究。色谱柱为C18(4.6 mm×250 mm,5μm),流动相为乙腈-0.1%磷酸溶液(含0.1%三乙胺)(3∶97),检测波长为207 nm,流速为1.0 mL/min,柱温30℃,进样量10μL。盐酸麻黄碱进样浓度在0.005~0.06 mg/mL(0.05~0.6μg范围内,峰面积盐酸麻黄碱含量呈良好的线性关系(R^2=0.9999),样品平均回收率为100.22%(n=6),RSD为1.47%。本方法简便、准确度高、重复性好,为进一步控制麻杏石甘口服液的质量标准提供了依据。

In order te improve the quality standard of Maxingshigan Orai solution,an HPLC method for the content determination of Orai solution in Maxingshigan particle was developed.The isolation was performed on a C18 column(4.6 mm×250 mm,5μm)with mobile phase conemting of 0.1%phosphoric acig(0.1%Triethylamine solution)and acetonitrile(3:97).The detection wave,length was 207 nm.The flow rate was 1 mL/min.The column temperature was 30 k,and injection volume was 10μL.There was a good linear correlation between the peak areas and Orai solution the concentrations of Orai solution at the range of 0.005〜0.06 mg/mL(R^2=0.9999)by HPLC.The average recovery was 100.22%with RSD od 1.47%(n=6,The results indicate that the method is simple,accurate and repeatable,and it can be used for the quality controi of Maxingshican Particle.