HPLC同时测定止喘灵口服液中氢溴酸东莨菪碱、硫酸阿托品、盐酸麻黄碱和盐酸伪麻黄碱的含量

Simultaneous determination of scopolamine hydrobromide,atropine sulfate,ephedrine hydrochloride and pseudoephedrine hydrochloride in Zhichuanling oral liquid with HPLC

目的：建立同时测定止喘灵口服液中氢溴酸东莨菪碱、硫酸阿托品、盐酸麻黄碱和盐酸伪麻黄碱含量的高效液相色谱法。方法：采用AgelaDurashellRP-C18色谱柱（4．6mm×250mm，5μm），流动相为乙腈-磷酸钠缓冲液（含17．5mmol·L。十二烷基硫酸钠的0．07mol·L-1磷酸钠溶液，用磷酸调节pH6．0）（30：70），流速0．9mL·min-1，检测波长207nm，柱温25℃。结果：氢溴酸东莨菪碱、硫酸阿托品、盐酸麻黄碱和盐酸伪麻黄碱分别在0．02121—1．0605，0．01114-0．557，0．20056～10．028，0．07033～3．5165μg与峰面积呈良好的线性关系，r分别为0．9993，0．9996，0．9997，0．9996；平均回收率（n=6）分别为101．9％，99．80％，100．3％，100．2％。结论：该方法快速简便，重复性好，专属性强，可作为止喘灵口服液的质量控制方法之一。

Objective： To establish an HPLC method for determining the contents of scopolamine hydrobromidc, atropine sul- fate, ephedrine hydrochloride and pseudoephedrine hydrochloride in Zhichuanling oral liquid. Method： Agela Durashell RP-C18 （4. 6 mm 250 mm, 5μm） was adopted, with acetonitrile-sodium phosphate buffer solution （0.07 mol·L-1 sodium phosphate solution with 17. 5 mmol · L-1 sodium dodecylsulfate adjusted to pH 6. 0 with phosphoric acid solution） （30： 70） as the mobile phase. The flow rate was 0. 9 mL · min-1, the detection wavelength was 207 nm, and the column temperature was 25 ℃. Result： Scopolamine hydrobromide, atropine sulfate, ephedrine hydrochloride and pseudoephedrine hydrochloride showed good hnear relations with peak ar- eas within the concentration range of 0. 021 21-1. 060 5μg （r =0. 999 3）, 0. 011 14-0. 557 μg （r =0. 999 6）, 0. 200 56-10. 028 μg （r =0. 999 7） and 0. 070 33-3. 516 5 μg （r =0. 999 6）, respectively, with the average recoveries of 101.9%, 99. 80%, 100. 3%, 100. 2% （n =6）. Conclusion： The method was so quick, simple, highly reproducible and specific that it could be used as one of quality control methods of Zhichuanling oral liquid.