HPLC法同时测定恒古骨伤愈合剂中东莨菪碱和硫酸阿托品限量的研究

Study on Simultaneous Determination of Scopolamine and Atropine Sulfate Limits of OsteoKing by HPLC

目的:同时测定恒古骨伤愈合剂中东莨菪碱和硫酸阿托品的含量,建立其限量检查方法,旨在为有效控制恒古骨伤愈合剂的质量及安全性提供可靠依据。方法:采用高效液相色谱(HPLC)法进行测定,色谱条件为固定相采用色谱柱Diamonsil C_(18)(250 mm×4.6 mm,5μm),流动相为乙腈∶0.07 mol·L^(-1)磷酸钠溶液(用磷酸调节pH值至4.5)(11∶89),柱温:30℃,检测波长:205 nm,流速:1 mL·min^(-1)。结果:东莨菪碱和硫酸阿托品分别在0.0037~0.1180 mg·mL^(-1)、0.0024~0.0774 mg·mL^(-1)浓度范围内与峰面积呈良好的线性关系;平均回收率分别为97.25%、97.61%,RSD值分别为2.32%、2.44%(n=9)。结论:该方法合理可行、准确可靠,可用于恒古骨伤愈合剂中东莨菪碱和硫酸阿托品的限量检查。

Objective:To simultaneously determine the contents of scopolamine and atropine sulfate in OsteoKing,and to establish the method for limit test,so as to provide a reliable basis for effectively controlling the quality and safety of OsteoKing.Methods:High performance liquid chromatography(HPLC)method was used.The chromatographic conditions were that the stationary phase was Diamonsil C_(18)(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile was 0.07 mol·L^(-1)sodium phosphate solution(pH was adjusted to 4.5 with phosphoric acid)(11∶89).The column temperature was 30℃.Detection wavelength:205 nm.Flow rate:1 mL·min^(-1).Results:Scopolamine and atropine sulfate in the concentration range of 0.0037-0.1180 mg·mL^(-1),0.0024-0.0774 mg·mL^(-1)respectively have a good linear relationship with the peak area.The average recovery rates were 97.25%,97.61%respectively,and the RSD values were 2.32%,2.44%(n=9)respectively.Conclusion:The method is reasonable,feasible,accurate and reliable,and it can be used for the limit test of scopolamine and atropine sulfate.