摘要
目的:建立适用于测定含L-酒石酸、苯磺酸、马来酸、琥珀酸、富马酸、枸橼酸、草酸、L-苹果酸化学对照品中有机酸含量的高效液相色谱法。方法:采用Kromasil Eternity XT-5-C_(8)(250 mm×4.6 mm,5μm)色谱柱或Waters Xbridge C_(18)(250 mm×4.6 mm,5μm)色谱柱,以0.02 moL·L^(-1)磷酸二氢钾溶液(A)-甲醇(B)为流动相,梯度洗脱,流速0.5 mL·min^(-1),检测波长210 nm,柱温20℃。结果:8个有机酸在各自范围内线性关系良好(r≥0.9998);精密度(RSD≤2%)、稳定性(RSD≤2%)、重复性(RSD≤2%)良好;平均加样回收率(n=9)为98%~102%。通过该方法对多种含有机酸化学对照品进行有机酸含量测定,理论值与测定值接近。结论:该方法适用性良好,可用于含L-酒石酸、苯磺酸、马来酸、琥珀酸、富马酸、枸橼酸、草酸、L-苹果酸化学对照品中有机酸的含量测定。
Objective:To establish a high-performance liquid chromatography for the determination of L-tartaric acid,benzenesulfonic acid,maleic acid,succinic acid,fumaric acid,citric acid,oxalic acid and L-malic acid in chemical reference standards.Methods:The Kromasil Eternity XT-5-C_(8)(250 mm×4.6 mm,5μm)column or Waters Xbridge C_(18)(250 mm×4.6 mm,5μm)column was used.The mobile phase consisted of 0.02 moL·L^(-1) KH_(2)PO_(4)(A)-methanol(B),with gradient elution at 0.5 mL·min^(-1).Detection wavelength was 210 nm,the column temperature was 20℃.Results:All eight organic acids showed good linearity within their respective ranges(r≥0.9998).The method demonstrated good precision(RSD≤2%),stability(RSD≤2%)and repeatability(RSD≤2%).The average recovery rate(n=9)was 98%-102%.The method was applied to the determination of organic acid content in various chemical reference standards containing organic acids,and the measured values closely matched the theoretical values.Conclusion:The method is suitable for the determination of L-tartaric acid,benzenesulfonic acid,maleic acid,succinic acid,fumaric acid,citric acid,oxalic acid and L-malic acid in chemical reference products.
作者
马玲云
孟雨馨
翟晨斐
冯玉飞
刘倩
牛剑钊
孙会敏
MA Ling-yun;MENG Yu-xin;ZHAI Chen-fei;FENG Yu-fei;LIU Qian;NIU Jian-zhao;SUN Hui-min(National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《药物分析杂志》
北大核心
2025年第4期590-597,共8页
Chinese Journal of Pharmaceutical Analysis
关键词
有机酸
含量测定
化学对照品
高效液相色谱法
富马酸
马来酸
枸橼酸
organic acids
content determination
chemical reference standards
high-performance liquid chromatography
fumaric acid
maleic acid
citric acid
