高效液相色谱法测定烟酰胺片的含量及有关物质

目的：建立同时测定烟酰胺片的含量及有关物质的HPLC法。方法：Kromasil C18色谱（250mm×4．6mm，5μm），流动相为0．01mol·L^-1磷酸二氢钾溶液-水-甲醇．乙睛（0．5：79．5：15：5），流速0．8ml·min^-1，检测波长262nm。结果：烟酰胺与有关物质分离良好，烟酰胺浓度在0．4—209．7μg·ml^-1范围内与峰面积呈良好的线性关系，r=0．9999，平均回收率为99．7％，RSD0．6％（n=6）。结论：方法灵敏，准确和专属，可用于烟酰胺片的含量测定及有关物质的质量控制。

Detemination of Nicotinamide Tablets and Its Related Substances by HPLC

Objective： To establish an HPLC method for determination of nicotinamide tablets and its related substances. Method： The Kromasil C18 column （250mm × 4.6mm,5 μm） was used, the mobile phase was 0.01 mol· L^ - 1 potassium dihydrogen phosphate solution-water-methanol-acetonitrile （0.5： 79.5： 15： 5 ）, the flow rate was 0.8ml· min^ - 1, the detection wavelength was 262nm. Result： The nicotinamide and related substances could be baseline separated, the linear range of nicotinamide was 0.4 -209.7 μg· ml^- 1 r = 0. 999 9, the average recovery was 99.7% ,RSD 0.6% （n = 6）. Conclusion： The method is specific, sensitive and accurate, it can be used for quality control of nicotinamide tablets and its related substances.