Study and Control of Two Potential Toxic Impurities in Vitamin B6 Tablets by HPLC Method
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.
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