0.04%硫酸阿托品滴眼液的制备与质量控制

Preparation and Quality Control of Dilute Atropine Sulfate Eye-drops

目的:建立0.04%硫酸阿托品滴眼液的制备工艺及其质量控制方法。方法:取硫酸阿托品与辅料制成浓度为0.04%的微量硫酸阿托品滴眼液,以乙腈-水(55∶45)为流动相,采用高效液相色谱法测定硫酸阿托品的含量。结果:所得制剂为无色澄明液体;硫酸阿托品检测浓度线性范围为10～60μg/ml(r=0.9999),平均回收率为100.2%(RSD=0.95%,n=9)。结论:该制剂制备工艺简单,含量测定方法简便、准确,质量可控。

OBJECTIVE： To establish the preparation process and method of quality control of dilute atropine sulfate eye drops. METHODS： Mixing atropine sulfate with additives in water to prepare 0.04% atropine sulfate eye drops. And determined the content of atropine sulfate by HPLC, the system consisted of C18 column and mobile phase of acetonitrilewater （55 ： 45）. RESULTS： The product is colorless and clearing liquid.The linear range of atropine sulfate was 10-60μg/ml（r = 0. 9 999） .The average recovery rate was100.2% （RSD = 0.95%, n= 9） . CONCLUSION： The preparation process of dilute atropine sulfate eye-drops is simple and the method of quality control by HPLC is reliable.