磺胺嘧啶麻黄碱滴鼻液定性定量方法研究

Qualitative and quantitative method of sulfadiazine and ephedrine hydrochloride nasal drops

目的研究磺胺嘧啶麻黄碱滴鼻液的定性定量方法。方法采用化学反应法及HPLC法定性定量鉴别处方中的磺胺嘧啶及盐酸麻黄碱。采用HPLC法测定磺胺嘧啶及盐酸麻黄碱的含量,色谱柱为Hibar RP-18endcapped（150 mm×4.6 mm,5μm）,流动相为磷酸盐缓冲液（pH值为3.0±0.1）-乙腈（90∶10）,流速1.0mL·min-1,检测波长210 nm。结果化学反应和HPLC法均能定性鉴别磺胺嘧啶及盐酸麻黄碱。磺胺嘧啶和盐酸麻黄碱分离良好;进样浓度分别为99.96-299.88μg·m L^-1（r=0.999 8,n=5）和19.86-59.58μg·m L^-1（r=0.999 9,n=5）与峰面积呈良好的线性关系。磺胺嘧啶和盐酸麻黄碱的平均回收率在98.0%-100%,RSD均〈1.2%（n=3）。结论本方法简便、快速、准确,重复性好,可用于磺胺嘧啶麻黄碱滴鼻液的质量控制。

Objective To establish a qualitative and quantitative method of sulfadiazine and ephedrine hydrochloride nasal drops. Methods Chemical reaction and HPLC methods were used to identify sulfadiazine and ephedrine hydrochloride. HPLC method was established to determine sulfadiazine and ephedrine hydrochloride. The Hibar RP-18 endcapped（150 mm×4.6 mm, 5 μm） column was used. The flow rate was 1.0 mL·min^- 1 and the detective wavelength was 210 nm. Results Sulfadiazine and ephedrine hydrochloride were identified by chemical reaction and HPLC method. Sulfadiazine and ephedrine hydrochloride were well separated. The calibration curve of sulfadiazine and ephedrine hydrochloride were showed a good linearity at 99.96- 299.88 μg·mL^- 1（r =0.999 8, n=5） and 19.86-59.58 μg·mL^- 1（r = 0.999 9,n = 5）. The average recoveries were at 98.0%- 100.0% with RSD 1.2%（n = 3）. Conclusion This method is rapid, convenient and accurate, which can be used for the quality control of sulfadiazine and ephedrine hydrochloride nasal drops.