反相高效液相色谱法测定复方磺胺嘧啶滴鼻液中磺胺嘧啶和盐酸麻黄碱含量

RP-HPLC determination of sulfadiazine and ephedrine in compound sulfadiazine nasal drops

目的建立了一种反相高效液相色谱-紫外检测法用于复方磺胺嘧啶滴鼻液中磺胺嘧啶和盐酸麻黄碱的含量测定。方法色谱柱为Zorbax Bonus RP C18（150mm×4．6mm，5μm），流动相为0．050mol·L^-1磷酸二氢钾溶液（含0．5％三乙胺，用磷酸调节pH值至2．3）-甲醇（80：20），盐酸麻黄碱的检测波长为216nm，磺胺嘧啶为265nm。结果磺胺嘧啶和盐酸麻黄碱分别在3．3～33．6μg·mL^-1，6．0～60．75μg·mL^-1峰面积和浓度呈线性关系，相关系数均为0．9996，磺胺嘧啶和盐酸麻黄碱的平均回收率分别为101．1%和100．0％。以文献方法作为参考方法，通过F-检验核对了定量方法的精密性，磺胺嘧啶和盐酸麻黄碱的两方法平均偏差的比值均接近于1．0。结论该分析方法准确、稳定，可用于复方磺胺嘧啶滴鼻液的质量控制。

OBJECTIVE To establish an isocratie liquid chromatography method for the quantitative determination of sulfadiazine and ephedrine in compound sulfadiazine nasal drops. METHODS Zorbax Bonus RP C18 （150 mm × 4.6 mm, 5μm） was used. The mobile phase consisted of methanol： 0. 010 mol · L^-1 potassium dihydrogen phosphate （20： 80） containing 0.5% triethylamine, adjusted with phosphoric acid to pH=2.3. Ephedrine was detec ted at 216 nm, and sulfadiazine at 265 nm. RESULTS The linear range of sulfadiazine was 3. 3～33. 6 μg·mL^-1, and that of ephedrine was 6.0～60.75 μg·mL^-1. Both the correlation coefficients for linear regession were 0. 9996. The average recoveries were 101.1% for sulfadiazine and 100.0% for ephedrine, respectively. The precision was checked in terms Of F-test variance ratio using the literal method as referenee. The ratio of variances of the two methods for sulfadiazine and ephedrine was close to unity, conforming to the good precision. CONCLUSIONS An isocratic liquid chromatography method has been developed for the quantitative determination of sulfadiazine and ephedrine in compound sulfadiazine nasal drops. The method is stable and useful in the quality control of compound sulfadiazine nasal drops.