硫酸阿托品注射液两种含量测定方法的比较

摘要

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pH值至5.0)为流动相,检测波长为225nm,流速为1.0mL· 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·mL-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 determina-tion 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-1 Potassium dihydrogen phosphate solution-acetonitrile(80:20), the detec-tion wavelength was 225nm,the flow rate was 1.0 mL·min-1 and the column temperature was 30℃,and the injection volume was 20μL. Results:The linear range of atropine sulfate was 0.004861~0.38890mg·mL-1(r=0.9999).The average recovery was 98.90%, RSD=0.86%(n=9). Conclusion:The method is simple, rapid, accurate, and reliable. The method can determine at-ropine sulfate satisfactorily. Experimental results verify the superiority of HPLC than UV.