Preparation And Quality Control Of Cyproheptadine Hydrochloride Syrup

Objective:To prepare cyproheptadine hydrochloride syrup and establish effective and stable analyses method for quality control.Method:Cyproheptadine hydrochloride is commonly used as antihistamines,tablets dosage and cream dosage are sold in currently in China marketing which is mainly for the adults.Oral tablets dosage is not very suitable for Children and old person who have the difficulty for swallowing.To develop cyproheptadine hydrochloride syrup can avoid this disadvantage and have good market benefit.In theformulation study,physical and chemical properties were studied,the absorption peakwavelength was studied by UV and crystal form was studied byX-RD.The content determination of cyproheptadine hydrochloride was established by high performance liquid chromatography(HPLC)and investigate precision of the method.Solubility and oil-water partition coefficient were determined.A destructive test was conducted to investigate its stability and the stability of raw materials was investigated by accelerated test.Syrup was prepared with cyproheptadine hydrochloride as main ingredient.Two kinds of methods were conducted for preparing syrup.Establish a method of quality control including identification,examination and content determination.Result:Cyproheptadine hydrochloride had a maximum absorption peak at 226nm and286nm wavelength and 286nm was selected as the detection wavelength in the determination of cyproheptadine hydrochloride.Results of X-RD and DSC showed that cyproheptadine hydrochloride was multiple crystal compound.The linear equation of calibration curve was:A=46007C+33709,R~2=0.9999,the intra-day precision and the inter-day precision were both less than 2%.Within 24 hours,the methanol solution of cyproheptadine hydrochloride was stable.The solubility results showed that it is slightly soluble in water medium.It need auxiliary solvent in the preparation of syrup.In destruction test,cyproheptadine hydrochloride was stable in acid and alkali solution when oxidative damage was with impurity peak in chromatogram.Raw material and mixing raw materials after accelerated tests were all in steady state.The results of identification,examination and content determination were in accordance with the quality requirements of syrup.Conclusion:The cyproheptadine hydrochloride was prepared successfully.The preparation method was simple.The established quality standard was in accordance with quality requirements of syrup in Chinese pharmacopoeia.