高效液相色谱法测定叶酸片中有关物质的含量  

Determination of related substances in folic acid tablets by HPLC

作　　者：李雪莲 肖学菊 崔德林 韩雅慧 易斌 LI Xue-lian;XIAO Xue-ju;CUI De-lin;HAN Ya-hui;YI Bin(Medicine Research&Development Center,Beijing Scrianen Pharmaceutical Co.,Ltd.,Beijing 100176)

机构地区：[1]北京斯利安药业有限公司药物研发中心,北京100176

出　　处：《中南药学》2024年第9期2429-2432,共4页Central South Pharmacy

摘　　要：目的建立叶酸片中有关物质的检测方法。方法用Besil C_(18)-B(4.6 mm×250 mm,3.5μm)色谱柱,以磷酸盐缓冲溶液-甲醇为流动相,梯度洗脱,流速0.8 mL·min^(-1),柱温35℃,检测波长280 nm。结果叶酸与6个已知杂质均能良好分离。3批样品测定结果显示,已知杂质、其他最大单个杂质和杂质总量均符合质量标准规定。结论本方法灵敏度高,专属性强,准确度高,可用于叶酸片中有关物质的测定。Objective To establish an HPLC method to determine the related substances in folic acid tablets.Methods The determination was performed on a Besil C_(18)-B column(4.6 mm×250 mm,3.5µm).The mobile phase consisted of phosphate buffered solution and methanol with gradient elution.-The flow rate was 0.8 mL·min 1,the column temperature maintained at 35℃,and the detection wavelength was 280 nm.Results The resolutions between the peaks of folic acid and 6 known impurities were good.The content of folic acid in three batches samples showed that the known impurities and the maximum single unknown impurity and the total impurity complied with the quality standards.Conclusion The method is simple,accurate,and can be used for the determination of related substances in folic acid tablets.

关 键 词：叶酸 有关物质 高效液相色谱法 

分 类 号：R927[医药卫生—药学]