离子交换色谱法检测尿液草酸根、磷酸根和枸橼酸根的性能评价  

Detection of oxalate,phosphate and citrate in urine by ion exchange chromatography and its performance evaluation

作　　者：尹晶平[1] 郑东 张政 丰斌[1] 祁松楠 唐琴晴 黄惠芳[1] 邱骏[1] YIN Jingping;ZHENG Dong;ZHANG Zheng;FENG Bin;QI Songnan;TANG Qinqing;HUANG Huifang;QIU Jun(Department of Clinical Laboratory,the First Affiliated Hospital of Soochow University,Suzhou 215006,Jiangsu,China)

机构地区：[1]苏州大学附属第一医院临床检测中心,江苏苏州215006

出　　处：《临床检验杂志》2020年第5期325-329,共5页Chinese Journal of Clinical Laboratory Science

摘　　要：目的建立离子交换色谱法定量检测尿液草酸根、磷酸根和枸橼酸根的方法,并对其进行性能分析评价。方法采用离子交换色谱法定量检测尿液样本中草酸根、磷酸根和枸橼酸根含量。根据《中国药典》(2015年版)通则中9012"生物样品定量分析方法验证指导原则"对所建方法的线性范围、检出限、精密度、样本稳定性、回收率和携带污染率等基本性能进行确认。结果离子交换色谱法检测尿液草酸根、磷酸根和枸橼酸根的线性范围分别为0.5~50 mg/L、1~100 mg/L、1~100 mg/L,检出限分别为0.01 mg/L、0.02 mg/L、0.02 mg/L,定量下限分别为0.5 mg/L、1.0 mg/L、1.0 mg/L,批内变异系数(CV)和批间CV均小于5%,回收率分别为92.00%~101.56%、100.10%~101.80%、97.16%~100.80%。结论建立的离子交换色谱法基本性能符合评价标准,能够灵敏且准确地检测尿液草酸根、磷酸根和枸橼酸根含量。Objective To establish a method of ion exchange chromatography for quantitative detection of oxalate,phosphate and citrate in urine and verify its analytical performance.Methods The contents of oxalate,phosphate and citrate in urine samples were quantitatively determined by ion exchange chromatography according to the general rules of Chinese Pharmacopoeia(2015 edition)9012“guidelines for verification of methods for quantitative analysis of biological samples”,the basic performances of the established method,including linearity,detection limit,precision,sample stability,recovery and carrying contamination rate were confirmed.Results The linear ranges of oxalate,phosphate and citrate detected in urine by ion exchange chromatography were 0.5 to 50 mg/L,1 to 100 mg/L and,1 to 100 mg/L,the detectable limits were 0.01 mg/L,0.02 mg/L and 0.02 mg/L respectively,and the lower limits of the quantification were 0.5 mg/L,1.0 mg/L and 1.0 mg/L respectively.The within-batch variation coefficient(CV)and between-batch variation coefficient(CV)of the ion exchange chromatography for the determination of oxalate,phosphate and citrate were less than 5%,and the recovery rates of oxalate,phosphate and citric acid were 92.00%to 101.56%,100.10%to 101.80%and 97.16%to 100.80%.Conclusion The basic performance of the developed ion exchange chromatography accorded with the evaluation criteria,and the assay could detect the contents of oxalate,phosphate and citrate with high accuracy and sensitivity.

关 键 词：离子交换色谱法 性能评价 草酸根 磷酸根 枸橼酸根 

分 类 号：R446.9[医药卫生—诊断学]