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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 for the determination of phenobarbital, nitrazepam, vitamin B6 and chlorpheniramine maleate in compound Benifenanamin tablets, and to evaluate the uncertainty of measurement results. Methods The gradient elution was carried out with [MeOH-0.02 mol·L-1 ammonium acetate] (A) -methanol (B) as the mobile phase by HPLC. The detection wavelength was 254 nm. The procedure and procedure were analyzed and the specific uncertainties were quantified Degree component. The results showed that the content of chlorpheniramine maleate (1.67 ± 0.03) mg, vitamin B6 (4.12 ± 0.07) mg, phenobarbital (12.03 ± 0.20) mg, Nitrazepam (1.07 ± 0.02) mg. Conclusion The evaluation of measurement uncertainty in this paper provides a mathematical judgment method for improving the reliability of the determination of active ingredients in Compound Benixanamin Tablets and is of guiding significance for the quality control of Compound Benzene Nenamin Tablets.