HPLC法测定维生素B6片中2个潜在毒性杂质的研究及控制
Study and Control of Two Potential Toxic Impurities in Vitamin B6 Tablets by HPLC Method
赵慧琴 1毛会玲 1辛铭洁 1木其尔 1邵香敏1
作者信息
- 1. 郑州工业应用技术学院,河南 郑州 475000
- 折叠
摘要
目的:建立测定维生素B6 片中 2个潜在毒性杂质A、杂质B方法.方法:色谱条件为Kromasil C18(4.6 mm×250 mm,5 μm),0.04%戊烷磺酸钠溶液(用冰醋酸调节pH值至 3.0)-甲醇(85:15),检测波长为 219 nm.结果:杂质A在8.96 ng～357.15 ng的范围内峰面积呈良好的线性关系;杂质B在10.15～404.33 ng的范围内峰面积呈良好的线性关系;杂质A、杂质B的检测限分别约为 1.80、2.03 ng.结论:该方法专属性强、精密度高、线性良好、操作方便高效.
Abstract
Objective:To establish a method for determining two potential toxic impurities A and B in vitamin B6 tablets.Method:Chromatographic conditions:Kromasil C18(4.6 mm×250 mm,5 μm),0.04%sodium pentane sulfonate solution(adjusted to pH 3.0 with glacial acetic acid)-methanol(85:15),detection wavelength of 219 nm.Result:The peak area of impurity A showed a good linear relationship within the range of 8.96 ng～357.15 ng.The peak area of impurity B shows a good linear relationship within the range of 10.15～404.33 ng.The detection limits for impurity A and impurity B are approximately 1.80 ng and 2.03 ng,respectively.Conclusion:This method has strong specificity,high precision,good linearity,and convenient and efficient operation.
关键词
维生素B6/杂质A/杂质B/高效液相Key words
vitamin B6/impurity A/impurity B/high efficiency liquid phase引用本文复制引用
出版年
2024
NETL
NSTL
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