盐酸克林霉素胶囊的溶出度研究

目的建立盐酸克林霉素胶囊的溶出度测定方法。方法以磷酸二氢铵溶液(取磷酸二氢铵2.88g,加水溶解并稀释成1000mL,用80%磷酸溶液调节pH值至3.0)为溶出介质,检测波长为214nm,以磷酸二氢铵溶液(取磷酸二氢铵2.88g,加水溶解并稀释成1000mL,用80%磷酸溶液调节pH值至3.0)-甲醇(210∶300)为流动相,流速0.7mL/min。结果盐酸克林霉素0.332~6.640μg的范围内,线性关系良好,Y=-3844+3.542e+004X,r=0.9962(n=6)。结论方法快速准确,可作为盐酸克林霉素胶囊的质量控制方法。

Study on Determining the Dissolution of Clindamycin Hydrochloride Capsule

Objective To determine the dissolution of clindamycin hydrochloride capsule.Methods Solutoin Ammonium dihydrogen phosphate（ammonium dihydrogen phosphate 2.88g,dissolve and dilute with water to 1000mL,and adjust pH in with 80% phosphoric acid solution to 3.0） was used as dissolution medium,wavelength 214nm was used for detection,ammonium dihydrogen phosphate（ammonium dihydrogen phosphate 2.88g,dissolve and dilute with water to 1000mL,and adjust pH in with 80% phosphoric acid solution to 3.0）-methanol（210∶300） was used as mobile phase,？ ow rate 0.7mL/min.Results In the range from 0.332μg to 6.640μg of clindamycin hydrochloride,the linear relation was good,Y =-3844＋3.542e＋004X,r=0.9962（n=6）.Conclusion This method is fast and accurate,can be a quality control method for clindamycin hydrochloride capsule.