硫酸阿托品注射液两种含量测定方法的比较

Determination of Atropine Sulfate injection by HPLC and compare with UV

目的 ：建立高效液相色谱法（HPLC法）测定硫酸阿托品注射液的含量,并与现行标准紫外分光光度法（UV法）测定结果进行比较,为今后科学制定硫酸阿托品注射液的含量测定方法提供参考依据。方法：采用高效液相色谱法测定硫酸阿托品注射液中硫酸阿托品的含量,以Agilent C18（150mm×4.6mm,5μm）为色谱柱,0.03mol·L-1磷酸二氢钾溶液-乙腈（80∶20）（用磷酸或氢氧化钠试液调节p H值至5.0）为流动相,检测波长为225nm,流速为1.0m L·min-1,柱温为30℃,进样量为20μL。结果：硫酸阿托品的线性范围为0.004861∽0.38890mg·m L-1（r=0.9999）,平均回收率为98.92%,RSD=0.86%（n=9）。结论：新建立的HPLC法简便、快速、准确、可靠,较紫外可见分光光度法有明显的优越性,建议修改原有方法。

Objective： To determine the content of atropine sulfate and compare with UV. Methods： The determination of atropine sulfate injection was performed by HPLC. The HPLC system consisted of a Agilent C18 column（150mm×4.6mm, 5μm）and the mobile phase of 0.05mol·L-1Potassium dihydrogen phosphate solution-acetonitrile（80∶20）, the detection wavelength was 225 nm,the flow rate was 1.0 m L·min-1and the column temperature was 30℃,and the injection volume was 20μL. Results：The linear range of atropine sulfate was 0.004861∽0.38890mg·m L-1（r=0.9999）.The average recovery was98.90%, RSD=0.86%（n=9）. Conclusion：The method is simple, rapid, accurate, and reliable. The method can determine atropine sulfate satisfactorily. Experimental results verify the superiority of HPLC than UV.