摘要
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 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.
出处
《中国药师》
CAS
2009年第7期912-914,共3页
China Pharmacist
