HPLC法测定复方苯硝那敏片中四种成分的含量及其不确定度分析  

Evaluation of Uncertainty and Determination of Four Components in Compound Denxiaonamin Tablets by HPLC

作　　者：郭娜 李栋 陈德俊[2] 牟英迪 

机构地区：[1]济南市食品药品检验检测中心,山东济南250001 [2]山东省食品药品检验所,山东济南250001

出　　处：《解放军药学学报》2014年第3期219-223,共5页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的建立测定复方苯硝那敏片中苯巴比妥、硝西泮、维生素B6、马来酸氯苯那敏含量的方法,并对测量结果进行不确定度评价。方法采用HPLC法,以〔甲醇-0.02 mol·L-1醋酸铵〕(A)-甲醇(B)为流动相进行梯度洗脱,检测波长254 nm;分析测定过程和步骤,量化具体的不确定度分量。结果按每片含量计算,复方苯硝那敏片样品中含有马来酸氯苯那敏(1.67±0.03)mg;维生素B6(4.12±0.07)mg;苯巴比妥(12.03±0.20)mg;硝西泮(1.07±0.02)mg。结论本文测量不确定度的评价为提高复方苯硝那敏片中有效成分含量测定的可信度提供一种数学判断方法,对复方苯硝那敏片的质量控制具有指导意义。Objective To establish a method to determinate chlorphenamine maleate, vitamin B6,phenobar- bital and nitrazepam in compound denxiaonamin tablets and to evaluate the uncertainty . Methods HPLC was used with methanol-ammonium acetate as the mobile phase at a detection wavelength of 254 nm. Influencing factors of uncertainty arising from the procedure of measurement were evaluated. Results The determined contents of chlor- phenamine maleate, vitamin B6, phenobarbital and nitrazepam in compound denxiaonamin tablets were （1.67 ± 0.03 ） rag, （4.12 ± 0.07 ） rag, （ 12.03 ± 0.20 ）mg and （ 1.07 ± 0.02） mg, respectively. Conclusion The evalu- ation of uncertainty provides a mathematical method for improving the credibility of component content in compound denxiaonamin tablets. This method is of practical significance for quality control of comoound denxiaonamin tablets.

关 键 词：复方苯硝那敏片 硝西泮 苯巴比妥 维生素B6 马来酸氯苯那敏 不确定度 

分 类 号：R927.2[医药卫生—药学]