盐酸非那吡啶有关物质及含量检测方法的改进

目的：优化和改进盐酸非那吡啶有关物质及含量的检测方法。方法：采用Phenomenex Luna C18（2）柱（4.6 mm×250 mm，5μm），以磷酸盐缓冲液（取磷酸氢二铵2.64 g，加水900 mL溶解后，用磷酸调节pH值至3.0，加水使成1000 mL）-甲醇（50∶50）为流动相，流量1.0 mL· min^-1，检测波长240 nm，柱温35℃。结果：盐酸非那吡啶与已知杂质2，6-二氨基吡啶、苯胺能有效分离。盐酸非那吡啶在0.504～25.220μg· mL^-1浓度范围内呈良好线性关系（r＝1.0000），检出限为1.0 ng；2，6-二氨基吡啶在0.213～5.315μg · mL^-1浓度范围内呈良好线性关系（ r＝1.0000），检出限为0.2 ng；苯胺在0.103～2.572μg · mL^-1浓度范围内呈良好线性关系（ r＝0.9999），检出限为1.9 ng。结论：改进后的方法更能有效控制盐酸非那吡啶的质量。

Improving the Determination for the Related Substances and Contents of Phenazopyridine Hydrochloride

Objective：To improve the determination method for the contents and related substances of phenazopyridine hydrochloride .Methods：HPLC was conducted on a Phenomenex Luna C 18 （2） 46 mm ×250 mm,5μm） column with phosphate buffer （ dissolve 2.64 g of dibasic ammonium phosphate in about 900 mL of water, adjust with phosphoric acid to pH 3.0, dilute with water to 1000 mL）-methanol （50∶50） as mobile phase,the flow rate was 1.0 mL· min^-1 , detected with UV 240 nm and the column temperature of 35℃.Results：An excellent separation was achieved for phenazopyridine hydrochloride , 2,6-diaminopyridine and aniline.The linear range was 0.504-25.220 μg· m L^-1 （ r=1.0000 ） and the detection limit was 1.0 ng for phenazopyridine hydrochloride .The linear range was 0.213-5.315 μg· mL^-1（r=1.0000） and the detection limit was 0.2 ng for 2,6-diaminopyridine.The linear range was 0.103-2.572 μg· mL^-1 （ r=0.9999 ） and the detection limit was 1.9 ng for aniline.Conclusion：The improved method can be used effectively to control the quality of phenazopyridine hydrochloride.