Preparation and Quality Control of Compound Zinc Sulfate Oral Solution / 中国药房

ABSTRACT

OBJECTIVE:To prepare compound zinc sulfate oral solution and establish its quality control method. METHODS: The oral solution was prepared with zinc sulfate and lysine hydrochloride as chief components. The content of lysine hydrochloride was determined by coordination titration and uv spectrophotometry, respectively, and the stability of the preparation was investigated. RESULTS: The oral solution was colorless or yellowish, with its identification and test results all in conformity with the related stipulation stated in Chinese Pharmacopeia(2005 edition). The average content of zinc sulfate labeled in the sample stood at 101%. The linear range of lysine hydrochloride was 3.2～9.6 ?g?mL-1(r=0.999 9) and its average recovery rate was 99.75%(RSD=0.27%, n=6). The preparation was stable within 6 months storing under room temperature. CONCLUSION: This preparative technology of compound zinc sulfate oral solution is simple and feasible, and the quality of which is stable and controllable.