高效液相色谱法测定注射用维生素B6有关物质

Determination of related substances of vitamin B6 for injection by HPLC

目的建立以高效液相色谱法测定注射用维生素B6有关物质的方法。方法采用Diamon-sil^TM C18，5μm250mm×4．6mm，以甲醇-0．06％庚烷磺酸钠（含1．2％冰醋酸）（30：70）为流动相，检测波长为291nm，流速为1．0ml／min，以自身对照法计算有关物质含量。结果线性范围在600～1400μg／ml浓度范围内，浓度与峰面积呈很好的线性关系（r=0．9998）。结论高效液相色谱法简便、快速，重复性好，结果准确，能准确检测产品中的杂质，有效控制注射用维生素B6的质量，可作为现行药典方法的补充。

Objective To establish a HPLC method to determine the related substances of vitamin B6 for injection. Methods HPLC method was adopted with Diamonsil^TM C18,5μm 250mm ×4.6mm;the mobile phrase was methanol-0.06% （contain 1.2% glacial acetic acid） （30 ： 70）. The flow rate was 1.0ml/ml. The detective wavelength was 291nm. Results The calibration curve was linear in the concentration range of 600- 1400μg/ml（ r = 0. 9998）. Conclusion The method is simple, rapid, accurate and reliable. As the supplement method of active pharmacopoeia, it can effectively control the quality of the product.