Pages: 369-372
Year: 2017 Issue:  5
Journal: Chinese Journal of Antibiotics
Abstract: Objective To investigate the dissolution behavior of cefaclor for suspension from different manufactures in four different dissolution media and to provide theoretical basis for evaluating the quality of the product.Methods The dissolution process of cefaclor for suspension was determined by the paddle method.The pH1.2 hydrochloric acid solution,the pH4.0 acetate buffer solution,the pH6.8 phosphate buffer solution and water were used as dissolution media.The rotation rate of paddle was 50r/min.The concentrations of samples in different medias were determined by HPLC with UV detector (254nm) and comparatively analyzed by the single point method.Results The sample from Lilly Suzhou Pharmaceutical Co,Ltd was taken as the reference preparation.All four dissolution profiles of cefaclor for suspension from six pharmaceutical manufactures were similar to the reference preparation.Only three dissolution profiles of cefaclor for suspension from the other four pharmaceutical manufactures were similar to the reference preparation.Conclusion There are differences in the quality among the products of four pharmaceutical manufactures and the reference preparation.The production process and excipients have important effects on the dissolution profiles ofcefaclor for suspension.