烟酸片中有关物质的测定及结果分析  

Determination and Result Analysis of Related Substances in Nicotinic Acid Tablets

作　　者：周琳 ZHOU Lin(Fujian Institute for Food and Drug Quality Control,Fuzhou 350001,China)

机构地区：[1]福建省食品药品质量检验研究院,福建福州350001

出　　处：《海峡药学》2022年第5期71-74,共4页Strait Pharmaceutical Journal

摘　　要：目的建立HPLC法测定烟酸片中有关物质,对国内市售的2家企业共118批烟酸片中有关物质测定结果进行比较分析。方法色谱柱:Sepax GP-C_(18)色谱柱(4.6 mm×250 mm,5μm);流动相A:醋酸溶液(取冰醋酸2 mL加入950 mL水中,用氨试液调节pH值至5.6,加水稀释至1000 mL);流动相B:乙腈-甲醇(50∶50),梯度洗脱;检测波长:250 nm;流速:1.0 mL·min^(-1);进样量:10μL。结果主成分色谱峰与各杂质峰完全分离,辅料对有关物质测定无干扰,测定的118批烟酸片最大单杂均小于0.03%,杂质总量均小于0.06%,2家企业有关物质结果差异较大。结论该方法专属性强,重复性好,可以准确、快速地测定烟酸片中有关物质。OBJECTIVE To establish an HPLC method for the determination of related substances in nicotinic acid tablets,and the results of related substances in niacin tablets from two domestic companies 118 batches were compared and analyzed.METHODS The separation was performed on Sepax GP-C_(18) column(4.6 mm×250 mm,5μm)with mobile phase A consisted of acetic acid solution potassium(pH 5.6),the mobile phase B consisted of acetonitrile-methanol(50∶50)with gradient elution.The flow rate was 1.0 mL·min^(-1).The detection wavelength was set at 250 nm,and the injection volume was 10μL.RESULTS The chromatographic peak of active pharmaceutical ingredient was completely separated from each impurity,and the supplementary materials did not interfere with the determination of related substances.The maximum unspecified impurities of 118 batches nicotinic acid tablets were less than 0.03%,and the total amount of impurities were less than 0.06%.CONCLUSION This method is specific and reliable,which can be used to determine the related substances in nicotinic acid tablets accurately and efficiently.

关 键 词：烟酸片 高效液相色谱法 有关物质 

分 类 号：R927[医药卫生—药学]