Preparation and Stability of Loperamide Hydrochloride Oral Solution / 中国药房

ABSTRACT

OBJECTIVE:To prepare loperamide hydrochloride oral solution,to establish its quality control method,and to study its stability.METHODS:Loperamide hydrochloride oral solution was prepared by using macrogol-400as the anxiliary solvent,water as the solvent,a reversed phase HPLC method was established to determination the content of principal agent loperamide hydrochloride and the method described in Chinese Pharmacopeia was applied to study its stability.RESULTS:A good linear relationship was obtained in the loperamide hydrochloride at concentration of0.05～0.5mg/ml(r=0.9995);The average recoveries of loperamide hydrochloride at the high,medium and low concentrations were100.6%、101.5%and99.1%respectively,with RSD being1.03%、0.49%and0.56%respectively;The stability showed no evident change as compared with before.CONCLUSION:The loperamide hydrochloride oral solution shows the advantages of simple preparation procedure,satisfactory stability and controllable quality.