Research Of Quality Analyses Of Clindamycin Palmitate Hydrochloride And Its Preparations And Roxithromycin Soft Capsules

In order to provide scientific basis for Chinese Pharmacopoeia Commission to revise quality control projects, this papaer carried out researches to improve standards of clindamycin palmitate hydrochloride drug substance and its preparations and roxithromycin soft capsules. The researches are national drug standards improving projects that come from Chinese Pharmacopoeia Commission.The first part of this paper studied the suited liquid chromatographic conditions for LC-MS analysis, then ten impurities in clindamycin palmitate hydrochloride drug substance were separated and identified by HPLC-ESI-MSn method, in which three impurities were new impurities. And the fragmentation rules of these impurities were discussed.The second part of this paper studied a new HPLC gradient elution method to determinate the related substances of clindamycin palmitate hydrochloride drug substance, dispersible tablets, granules and suspension. This chapter studied the chromatographic behavior and spectral characteristics of clindamycin palmitate and its impurities, and studied the experimental conditions such as chromatographic columns, mobile phases, a series of buffer salts and buffer salt concentrations, and detection wavelengths. And the new method was validated.The third part of this paper studied a capillary gas chromatography to determinate nine residual solvents in clindamycin palmitate hydrochloride. Systematic studies of different sample inject modes, chromatographic columns, column temperatures and solvent medium was developed, and the method was validated.The forth part of this paper studied dissolution mediums(different kinds of buffer solution, different pH, different concentrations of surfactant), rotational speeds and dissolution curves, then a new HPLC dissolution determination method for clindamycin palmitate hydrochloride dispersible tablets and suspension was developed and validated.The fifth part of this paper is to improve the quality standard of roxithromycin soft capsules. New dissolution medias was tested, and dissolving-out amount of roxithromycin soft capsules was determined with a specifically HPLC method. The TLC method of determining the related substances of roxithromycin soft capsules was changed to a HPLC method.