HPLC法测定硫酸阿托品滴眼液中硫酸阿托品的含量

Determination of Atropine Sulfate in Atropine Sulfate Ophthalmic Solution by HPLC

目的 建立高效液相色谱法测定硫酸阿托品滴眼液中硫酸阿托品的含量.方法 采用美国Agilent高效液相色谱仪,流动相为甲醇-0.04mol·L-1磷酸二氢钾溶液（40：60）,柱温为30℃,流速为1.0mL·min-1,检测波长为217nm.结果 硫酸阿托品的线性范围为0.2086～2.086μg（r=0.9998）;平均加样回收率（n=6）为97.80%（RSD=1.18%）.结论 该方法简便、准确,结果稳定,适用于硫酸阿托品滴眼液中硫酸阿托品含量的质量控制.

OBJECTIVE To establish a HPLC method for the determination of Atropine Sulfate in Atropine Sul- fate Ophthalmic Solution. METHODS US Agilent HPLC was used and the mobile phase consists of methanol- 0. 04mol .L- 1 potassium dihydrogen phosphate （40 ： 60） at the column temperature of 30℃. The flow rate was 1.0mL. min-1 and the detection wavelength was 217nm. RESULTS The linear ranges of Atropine Sulfate was 0. 2086- 2. 086μg（ r = 0. 9998）. The average recovery （ n = 6） was 97.80% （ RSD = 1.18% ）. CONCLUSION The method is sensitive, accurate and reliable for the quality control and evaluation of Atropine Sulfate Ophthalmic Solution.