Preparation and Quality Control of Dilute Atropine Sulfate Eye-drops / 中国药房

ABSTRACT

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 acetonitrile-water (55∶45).RESULTS: The product is colorless and clearing liquid.The linear range of atropine sulfate was 10～60?g/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.