Study on the Quality Standard of Compound Paracetamol and Amantadine Hydrochloride Tablets
Objective To perfect the quality standard of compound paracetamol and amantadine hydrochloride tablets and improve the quality control level of the quality standard.Methods The HPLC method was established for p-aminophenol impurities,the simultaneous determination of paracetamol,caffeine and chlorpheniramine.The HPLC method was established for the simultaneous determination of paracetamol,caffeine and chlorpheniramine,and the HPLC method was established for the simultaneous determination of the content uniformity of caffeine and chlorpheniramine.Results The established HPLC method for the determination of impurities,content and content uniformity has good linear relationship,accuracy,reliability and repeatability.According to the proposed standards,in 19 batches of samples,the content of caffeine in one batch exceeded the standard range,and the content uniformity of caffeine in one batch exceeded the standard range.Conclusion This study improved and perfected the quality control method,and provided the method and reference for more comprehensive quality control of compound paracetamol and amantadine hydrochloride tablets.
Quality controlCompound paracetamol and amantadine hydrochloride tabletsImpuritiesContent determinationContent uniformity
万方数据
维普
