反相高效液相色谱法测定硫酸阿托品注射液的含量

摘要

Objective To establish a HPLC method for determining the content of Atropine Sulfate Injection. Methods The RP - HPLC method was adopted. The column was Kromasil C18 column (250 mm × 4.6 mm, 5 μm), the mobile phase was 0.05 mol/L potassium dihydrogen phosphate solution (containing 0.002 5 mol/L heptane sodium sulfonate) - acetonitrile(82 : 18) (adjusting pH 5.0 with sodium hydroxide solution), the flow rate was 0. 8 mL/min and the detection wavelength was 225 nm. Results The linear range was 1. 002 4 -10. 024 μg( r = 0.999 75). The average recovery rate was 99. 81%, RSD =0. 79% (n = 6). Conclusion The method is simple,rapid,accurate and suitable for the quality control of Atropine Sulfate Injection.%目的 建立测定硫酸阿托品注射液含量的反相高效液相色谱法.方法 色谱柱为Kromasil C18柱(250 mm×4.6mm,5μm),流动相为0.05 mol/L磷酸二氢钾溶液(含0.002 5 mol/L庚烷磺酸钠,用氢氧化钠试液调节pH至5.0)-乙腈(82:18),流速为0.8 mL/min,检测波长为225 nm.结果 硫酸阿托品进样量在1.002 4~10.024μg范围内与峰面积线性关系良好(r=0.999 75),平均回收率为99.81%,RSD为0.79%(n=6).结论 该方法简便、快速,结果准确,适用于硫酸阿托品注射液的质量控制.