Quality Standard of Xiaochuan Oral Solution / 中国药房

ABSTRACT

OBJECTIVE: To establish xiaochuan oral oral solution quality control method.METHODS: Three kinds of main components' contents in xiaochuan oral solution were determined by HPLC.RESULTS: The prepared oral solution was brown liquid,with identification and tests all up to the standards specified in Chinese Pharmacopeia(2005 edition).The linear ranges of guaifenesin,ephedrine hydrochloride,and aminophylline(theophylline) were 7～13 ?g?mL-1(r=0.999 9),4.55～8.45 ?g?mL-1(r=0.999 8),and 10.64～19.76 ?g?mL-1(r=0.999 9),respectively,with the average recoveries at 99.35%(RSD=0.97%),100.40%(RSD=1.02%),and 100.57%(RSD=1.08%),respectively.CONCLUSION: The established quality control method could be used for quality control of it.