Preparation and Quality Control of Betamethasone Gel / 中国药房

ABSTRACT

OBJECTIVE:To prepare betamethasone gel and establish its quality control method. METHODS: Orthogonal experiment was carried out to optimize the formula of the base material and design the formula technology of betamethasone gel. The content of betamethasone in the gel was determined by UV-spectrophotometry with its stability investigated through centrifugalization,thermostabilization,cold-resistance and long-term tests. RESULTS: The preparation was off-white semitransparent gel,with its property identification in line with the standard specified in Chinese Pharmacopeia (2005 edition). The linear range of betamethasone was 6～36 ?g?ml-1 (r=0.999 9) and its average recovery rate was 98.88% (RSD=0.57%). The stability tests revealed no stratification of the gel. CONCLUSION: The preparation process is simple and the preparation is stable and controllable in quality.