HPLC法测定磺胺止咳口服溶液组分含量

Content determination of the two components in sulfanilamide cough oral suspension by HPLC method

目的建立磺胺止咳口服溶液含量测定的方法,以提高医疗机构制剂的质量标准。方法采用高效液相测定法,以Agilent Eclipse×HC-C18为色谱柱,以水—乙腈—三乙胺（799∶200∶1）（用氢氧化钠试液或冰醋酸调节p H值至5.9）为流动相;检测波长为240nm,流速1.0ml/min。结果在100~360μg/ml线性范围内,磺胺甲噁唑溶液的浓度与峰面积呈良好的线性关系,r=0.9999。在10~36μg/ml线性范围内,甲氧苄啶溶液的浓度与峰面积呈良好的线性关系,r=0.9999。平均回收率磺胺甲噁唑为100.2%（n=7）,甲氧苄啶为99.8%。磺胺甲噁唑日内RSD分别为0.78%、0.59%、0.38%;甲氧苄啶日内RSD分别为0.96%、0.76%、0.29%。结论本法简便、快速、准确、灵敏,可用于磺胺止咳口服溶液的质量控制。

Objective To establish a content determination method for sulfanilamide cough oral suspension,in order to improve the quality standards of preparations in medical institutions. Methods High performance liquid chromatography（ HPLC） method was used in this study,Agilent Eclispse × HC-C18 chromatographic column,with water-acetonitrile-triethylamine（ 799∶200∶1）（ with sodium hydroxide solution or glacial acetic acid to adjust p H value to 5. 9） as mobile phase; Detection wavelength was 240 nm,flow velocity was 1. 0ml / min. Results In the linear rangeof 100 ~ 360 μg / ml,good linear relationship was showed in the concentration of sulfamethoxazole solution with the peak area,r = 0. 9999. In the linear range of10 ~ 36μg / ml,good linear relationship was showed in the concentration of trimethoprim solution with the peak area,r =0. 9999. The average recovery of sulfamethoxazole was 100. 2%（ n = 7）,and trimethoprim was 99. 8%. The within-day precision of sulfamethoxazole was 0. 78%,0. 59% and 0. 78% respectively; and within-day precision of trimethoprim were 0. 96%,0. 76% and 0. 29% respectively. Conclusion The method was simple,rapid,accurate,sensitive,and could be used for quality control of sulfanilamide cough oral suspension.