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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 method for the determination of oral solution of sulfonamides and cough so as to improve the quality standard of preparation for medical institutions. Methods High performance liquid chromatography (HPLC) with Agilent Eclipse × HC-C18 column with water-acetonitrile-triethylamine (799: 200: 1) ) As mobile phase; detection wavelength of 240nm, flow rate of 1.0ml / min. Results In the linear range of 100 ~ 360μg / ml, the concentration of sulfamethoxazole showed a good linear relationship with the peak area, r = 0.9999. In the linear range of 10 ~ 36μg / ml, the concentration of trimethoprim solution showed a good linear relationship with the peak area, r = 0.9999. The average recovery was 100.2% for sulfamethoxazole (n = 7) and 99.8% for trimethoprim. The days RSD of sulfamethoxazole were 0.78%, 0.59% and 0.38%, respectively. The days RSD of trimethoprim were 0.96%, 0.76% and 0.29%, respectively. Conclusion This method is simple, rapid, accurate and sensitive and can be used for the quality control of sulfonamides oral solution.