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高效液相色谱法测定叶酸片中有关物质的含量

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目的 建立叶酸片中有关物质的检测方法.方法 用Besil C18-B(4.6 mm×250 mm,3.5 μm)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.
Determination of related substances in folic acid tablets by HPLC
Objective To establish an HPLC method to determine the related substances in folic acid tablets.Methods The determination was performed on a Besil C18-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.

folic acidrelated substanceHPLC

李雪莲、肖学菊、崔德林、韩雅慧、易斌

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北京斯利安药业有限公司药物研发中心,北京 100176

叶酸 有关物质 高效液相色谱法

2024

中南药学
湖南省药学会

中南药学

CSTPCD
影响因子:0.736
ISSN:1672-2981
年,卷(期):2024.22(9)