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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 C_(18)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=0.999 9,平均回收率为99.7%,RSD 0.6%(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。
Objective: To establish a HPLC method for simultaneous determination of nicotinamide tablets and related substances. METHODS: Kromasil C 18 chromatography (250 mm × 4.6 mm, 5 μm) was used with the mobile phase consisted of 0.01 mol·L -1 potassium dihydrogen phosphate solution-water-methanol-acetonitrile (0.5:79.5:15:5) , The flow rate of 0.8ml · min ~ (-1), detection wavelength of 262nm. Results: Nicotinamide was well separated from other related substances. The concentration of nicotinamide showed a good linear relationship with the peak area in the range of 0.4 ~ 209.7μg · ml ~ (-1), r = 0.999 9, the average recovery was 99.7%, RSD 0.6 % (n = 6). Conclusion: The method is sensitive, accurate and specific and can be used for the determination of nicotinamide tablets and the quality control of related substances.