反相高效液相色谱法同时测定愈酚伪麻待因口服溶液3组分含量

目的测定愈酚伪麻待因口服溶液中磷酸可待因、盐酸伪麻黄碱及愈创木酚甘油醚的含量。方法采用反相高效液相色谱法,色谱柱为Diamonsid^TM-C18柱（250mm×4.6mm,5μm）,以0.01mol/L的磷酸二氢钾（含0.002mol/L的庚烷磺酸钠,磷酸调pH至3.0）-乙腈（70：30）为流动相,检测波长215nm。结果磷酸可待因、盐酸伪麻黄碱、愈创木酚甘油醚质量浓度分别在8.56～68.48μg/mL,24.48～195.84μg/mL,80.72～645.76μg/mL范围内与峰面积线性关系良好,相关系数（r）均为0.9999,平均回收率分别为100.42%,99.96%,100.25%,RSD分别为0.86%,0.85%,1.00%（n=9）。结论所用方法简便可靠、重复性好,可用于愈酚伪麻待因口服溶液的质量控制。

Simultaneous Determination of Contents of Three Components in Guaifenesin Pseudoephedrine Hydrochloride and Codeine Phosphate Oral Solution by RP-HPLC

Objective To determine the contents of codeine phosphate,pseudoephedrine hydrochloride and guaifenesin in Guaifenesin Pseudoephedrine Hydrochloride and Codeine Phosphate Oral Solution.Methods The RP-HPLC method was established.The DiamonsidTM C18 column（250 mm × 4.6 mm,5 μm） was used.The mobile phase was 0.01 mol /L potassium dihydrogen phosphate solution（containing 0.002 mol /L sodium heptane sulfonate,adjusted to pH = 3.0 with phosphoric acid）-acetonitrile（V：V = 70：30）.The detection wavelength was set at 215 nm.Results The linear range of codeine phosphate was 8.56-68.48 μg /mL,pseudoephedrine hydrochloride was 24.48 195.84 μg /mL and guaifenesin was 80.72-645.76 μg /mL,respectively.The average recovery rates of codeine phosphate,pseudoephedrine hydrochloride and guaifenesin were 100.42% with RSD 0.86%,99.96% with RSD 0.85% and 100.25% with RSD 1.00%（n = 9）,respectively.Conclusion The method is simple and reliable,which can be used for the quality control of the preparation.