Preparation and Quality Control of Pazufloxacin Mesilate Ophthalmic Gel / 中国药房

ABSTRACT

OBJECTIVE:To prepare pazufloxacin mesilate ophthalmic gel and to establish its quality control method.METHODS:The gel was prepared with pazufloxacin mesilate ophthalmic as principal agent and with PVA-124 as base material.The content of pazufloxacin mesilate was determined by HPLC and the stability of the gel was investigated as well.RESULTS:The prepared gel was yellowish liquid and its property fitted the description of Chinese Pharmacopeia(2005 edition).The linear range of pazufloxacin mesilate was 20.0～80.0 ?g?mL-1(r=0.999 9),and the average recovery was 98.67%(RSD=0.79%,n=3).No stratification was noted for the sample within 2-month storage under room temperature.CONCLUSION:The preparation technique of the pazufloxacin mesilate ophthalmic gel is simple and feasible,its quality control method is rapid and the determination result is accurate and reliable.