摘要
目的:建立非等比例多组分制剂[间苯二酚-水杨酸(5∶1)]中间苯二酚的含量测定方法。方法:采用双波长分光光度法,以282 nm(间苯二酚最大吸收波长)为测定波长、320 nm为参比波长,测定并计算间苯二酚的含量。结果:间苯二酚质量浓度在15~40μg/ml范围内与吸光度差值的线性关系良好(r=0.999 2);间苯二酚的平均回收率为100.32%,RSD=1.67%(n=3)。结论:本方法快速简便,结果准确。非等比例多组分制剂中,宜优先选择高浓度成分进行含量测定,并使得测定波长下成分之间的吸光度值差异尽可能小。
OBJECTIVE:To establish the method for the content determination of dioxybenzene in unequal-proportional multicomponent preparation [dioxybenzene-salicylic acid(5 ∶ 1)]. METHODS:The content of dioxybenzene was determined and calculated by dual-wavelength spectrophotometry using 282 nm(maximum absorption wavelength of dioxybenzene)as detection wavelength and 320 nm as reference wavelength. RESULTS:The linear relationship of dioxybenzene in the range of 15-40 μg/ml to the absorbance difference was good(r=0.999 2). Average recovery of dioxybenzene was 100.32%(RSD=1.67%,n=3). CONCLUSIONS:The method is rapid,simple and accurate. The high concentration ingredient in the unequal-proportional multi-component preparation should be prior for the content determination. The detection wavelength should be selected to minimum the absorbance difference between ingredients as much as possible.
出处
《中国药房》
CAS
CSCD
2014年第41期3902-3904,共3页
China Pharmacy
基金
首都卫生发展科研专项重点攻关项目--医院制剂注册标准研究(No.首发2011200801)
北京市食品药品监督管理局项目:北京市医疗机构制剂应急品种质量标准及应急响应预案研究
北京市医疗机构制剂质量标准研究
关键词
双波长分光光度法
非等比例多组分制剂
间苯二酚
水杨酸
含量测定
Dual-wavelength spectrophotometry
Unequal-proportional multicomponent preparation
Dioxybenzene
Salicylic acid
Content determination