高效液相色谱法测定猪纤维蛋白原中枸橼酸离子含量  

Determination of citrate ion content in porcine fibrinogen by high performance liquid chromatography

作　　者：潘玲利 丁天美 张军东 PAN Lingli;DING Tianmei;ZHANG Jundong(Shanghai Li Kang Rui Biological Technology Co.,Ltd.,Shanghai 201707,China)

机构地区：[1]上海利康瑞生物工程有限公司,上海201707

出　　处：《上海医药》2024年第9期127-130,135,共5页Shanghai Medical & Pharmaceutical Journal

摘　　要：目的:建立定量测定生物制品猪纤维蛋白原中枸橼酸离子含量的高效液相色谱法,并进行方法学验证。方法:采用示差折光检测器和Agilent Hi-plex H色谱柱(7.7 mm×300 mm,8μm),以4 mmol/L硫酸溶液为流动相,柱温50℃,流速0.8 mL/min,进样量5μL进行色谱分析。结果:标准曲线的线性范围为5.01~15.04 mmol/L,线性相关系数r为0.9995;低、中、高3个浓度水平的平均回收率分别为104.0%、102.8%、97.6%,总平均回收率为101.5%(n=9),RSD为3.16%(n=9);中间精密度RSD为0.75%(n=12);耐用性比值为99.71%~100.49%。结论:该方法专属性强,准确度、精密度、耐用性良好,适用于猪纤维蛋白原中枸橼酸离子含量的检测。Objective:To establish a method for the determination of citrate ion content in porcine fibrinogen of biological products by high performance liquid chromatography(HPLC),and the method was validated.Methods:A refractive index detector and Agilent Hi-plex H column(7.7 mm×300 mm,8 mm)were used and the HPLC was performed with 4 mmol/L sulfuric acid solution as mobile phase at column temperature 50℃,flow rate 0.8 mL/min,and sample volume 5 mL.Results:The standard curve was linear over the range of 5.01-15.04 mmol/L with linear correlation coefficient r 0.9995.The average recoveries at low,medium and high concentrations were 104.0%,102.8%and 97.6%,respectively and the overall average recovery was 101.5%(n=9),and the overall relative standard deviation(RSD)was 3.16%(n=9).The RSD obtained from the intermediate precision was only 0.75%(n=12)and the durability ratio was 99.71%-100.49%.Conclusion:This method has strong specificity,good accuracy,precision,and durability,and is suitable for the determination of citric acid ion content in porcine fibrinogen.

关 键 词：高效液相色谱法 猪纤维蛋白原 枸橼酸离子 生物制品 

分 类 号：R973.1[医药卫生—药品] R927.11[医药卫生—药学]