高效液相色谱法测定硫酸阿托品注射液的含量

Determination of Atropine Sulfatefor Injection by HPLC

目的建立测定硫酸阿托品注射液含量的高效液相色谱(HPLC)法。方法采用CapcellPAKC18色谱柱(250mm×4.6mm,5μm),柱温35℃,以0.05mol/L磷酸二氢钠溶液(用磷酸调节pH至3.0)-乙腈(82∶18)为流动相,流速1.0mL/min,检测波长202nm。结果硫酸阿托品质量浓度在20.62～185.54μg/mL范围内与峰面积线性关系良好(r=1.0000),检测限为0.41μg,定量限为1.2μg,低、中、高3个质量浓度水平的回收率(n=3)分别为99.58%(RSD=0.96%),99.60%(RSD=0.53%),99.51%(RSD=0.41%)。结论HPLC法专属、简便、准确可靠,可作为该制剂的质量控制方法。

Objective To determine the content of Atropine Sulfate for Injection by HPLC. Methods HPLC was conducted on the Capcell PAK C18（250 mm×4.6 mm, 5 μm）column at the temperature of 35 ℃, with 0.05 mol/L sodium dihydrogen phosphate solution（adjusting pH to 3.0 with phosphoric acid）-acetonitrile （82：18） as the mobile phase and detected with UV 202nm and the flow rate of 1.0mL/min. Results The linear range was 20. 62 - 185.54 μg/mL（ r = 1. 000 0）. The limit of detection（LOD） was 0. 41 μg. The limit of quantitation （LOQ） was 1.2 μg. The average recovery rates （ n = 3） was 99.58% （ RSD = 0.96% ）, 99.60% （ RSD = 0. 53% ）, 99.51% （ RSD = 0. 41% ） respectively. Conclusion This method is specific, rapid and reliable.