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双波长分光光度法测定非等比例多组分制剂中的间苯二酚含量
引用本文:金锐,曾蔚欣,杨平,段松冷,刘俊丽,田佳懿,孙路路.双波长分光光度法测定非等比例多组分制剂中的间苯二酚含量[J].中国药房,2014(41):3902-3904.
作者姓名:金锐  曾蔚欣  杨平  段松冷  刘俊丽  田佳懿  孙路路
作者单位:首都医科大学附属北京世纪坛医院药剂科,北京100038
基金项目: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
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1540μg/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。

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

Content Determination of Dioxybenzene in Unequal-proportional Multi-component Preparation by Dual-wavelength Spectrophotometry
JIN Rui,ZENG Wei-xin,YANG Ping,DUAN Song-leng,LIU Jun-li,TIAN Jia-yi,SUN Lu-lu.Content Determination of Dioxybenzene in Unequal-proportional Multi-component Preparation by Dual-wavelength Spectrophotometry[J].China Pharmacy,2014(41):3902-3904.
Authors:JIN Rui  ZENG Wei-xin  YANG Ping  DUAN Song-leng  LIU Jun-li  TIAN Jia-yi  SUN Lu-lu
Institution:(Dept. of Pharmacy, Beijing Shijitan Hospital of Capital Medical University, Beijing 100038, China)
Abstract: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.
Keywords:Dual-wavelength spectrophotometry  Unequal-proportional multicomponent preparation  Dioxybenzene  Salicylic acid  Content determination
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