Research On Impurities In Clindamycin Phosphate And Revaluation Of Its Dosage Form

Clindamycin phosphate is a kind of lincomycin group antibiotics.It can be hydrol yzed to be clindamycin in vivo to show its effective antibiotic activity without any antib acterial activity in vitro.It obtains widespread application in the clinical treatments,whe reas there are a lot of clinical manifestations of the adverse drug reactions.There are thr ee main reasons:the first could be rapidly development of dosage form and strength,mi xuse of active pharmaceutical ingredient and weak basic research.The second is excess ively consuming in clinical treatments which increases its incidence of adverse reactions.The third is that the existent method to determine its impurities is not suitable enough and the specification should be improved.This issue studied the key quality factors in c lindamycin phosphate,while making a research on the relationship between its impurity profile and dosage forms.It can provide significant information for the pharmaceutical companies to develop formulation and improve processes,then upgrading quality.Opti mizing ulteriorly the specification will help people to get safe and effective medication.The mainly contributions of this study include the following aspects.To establish a method to determine residual triethylamine in clindamycin phosphat e.It was performed by headspace gas chromatography.This method appears to be low d etection limit,high sensitivity,good accuracy.It can be appropriate for determining the content of residual triethylamine in clindamycin phosphate.To improve a method to measure impurities in clindamycin phosphate.The conditi on of chromatography was optimized by comparing every existing method in official ph armacopoeias or specifications without any impurity reference substance.Finally,the dr aft European pharmacopoeia method is the best one because the most impurities can be detected and the resolution is the bestTo identify impurities in clindamycin phosphate by LCMS-IT-TOF and DGLC-MS combined column-switching and online demineralization technique.It proved that many impurities are the same as those recorded by the draft European pharmacopoeia.And th ere is an unknown impurity confirmed to be the transformation of spatial configuration of carbon NO.11 in clindamycin phosphate by MS and NMR.To study the impurity profile of clindamycin phosphate.Several batches active ph armaceutical ingredients and pharmaceutical preparations of clindamycin phosphate w ere detected by the draft European pharmacopoeia method.Revaluate the dosage forms of clindamycin phosphate by considering the relationship between the impurities and its dosage form and find that the general quality of the overall clindamycin phosphate and its dosage forms is good,but there are some shortcomings such as different preservative additives in the same dosage forms,large quantity range of impurities in dosage forms,different quality control standard and much difference of limitation of different dosage forms.