Preparation and Quality Control of Compound Ornidazole Gel / 中国药房

ABSTRACT

OBJECTIVE: To prepare compound ornidazole gel and conduct its quality control. METHODS: The gel was prepared with 0.6% carbopol - 940 as base and with ornidazole and cimetidine as main ingredients. Contents of 2 constituents were determined directely by UV - spectrophotometry. The stability of the finished product was investigated as well. RE-SULTSThe gel obtained was good in appearance, shaping and spreading. The linear ranges for ornidazole and cimetidine were all 0.5-32uuuuuuuuuug/ ml. The average recovery rates of ornidazole and cimetidine were 100.58% (RSD= 1.17%) and 100.59% (RSD=1.61%), respectively. The stability investigation results were in line with the requirement of Chinese Pharmacopeia 2000 version. CONCLUSION:The formula of compound gel is reasonable; its preparation technics is simple and the quality is reliable; and which meets the requirements of clinical medication.