HPLC法测定维生素B_(6)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

目的:建立测定维生素B_(6)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,5μm),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。

Objective:To establish a method for determining two potential toxic impurities A and B in vitamin B_(6) 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 of10.15~404.33 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.