HPLC-加校正因子自身对照法测定谷胱甘肽有关物质  

Determination of Related Impurities in Glutathione by HPLC Self-control with Correct Factor

作　　者：王福坚 黄孟秋 黄子健 陈新阳 蒋能 WANG Fu-jian;HUANG Meng-qiu;HUANG Zi-jian;CHEN Xin-yang;JIANG Neng(Guangzhou Baiyunshan Mingxing Pharmaceutical Co.,Ltd.,Guangdong Guangzhou 510250;Guangzhou Baiyunshan Pharmaceutical Holdings Co.,Ltd.,Guangdong Guangzhou 510130;Department of Pharmacy,Affiliated Tumor Hospital of Guangxi Medical University,Guangxi Nanning 530021,China)

机构地区：[1]广州白云山明兴制药有限公司,广东广州510250 [2]广州白云山医药集团股份有限公司,广东广州510130 [3]广西医科大学附属肿瘤医院药学部,广西南宁530021

出　　处：《广州化工》2021年第22期66-68,共3页GuangZhou Chemical Industry

基　　金：广西科技基地和人才专项(项目编号:桂科AD18281032)。

摘　　要：建立高效液相色谱(HPLC)加校正因子自身对照法测定谷胱甘肽有关物质。色谱柱:华谱Unitary反相色谱柱(C_(18) 4.6×150 mm 5μm);以磷酸盐-离子对缓冲液-甲醇体系为流动相;流速为1.0 mL/min;柱温为30℃;检测波长为210 nm。杂质A、B、C、D的校正因子分别为1.2、2.5、0.8、1.4。杂质A、B、C、D在线性范围内线性相关系数r≥0.9995,检出限分别为0.0021、0.0030、0.0045、0.0023μg,定量限分别为0.0071、0.0099、0.0150、0.0076μg;加标回收率分别为99.74%、101.22%、101.17%、101.62%。结果表明该方法灵敏度高、重现性好、稳定可控,适用于谷胱甘肽中有关物质的检测。The method for HPLC withself-controlwith correct factorfor the determination ofrelative impurities in glutathione was established.Huapu Unitary(C_(18)4.6 mm×150 mm,5μm)was used,the mobilephase was phosphate buffer solution-method program.The detection wavelength was 210 nm,the flowrate was 1.0 mL/min,the column temperature was 30℃.The correction factors of impurity A,B,C and Dwere1.2,2.5,0.8 and 1.4.The calibration curvesof glutathione,impurity A,impurity B,impurity C and impurity D showed good linearities with the correction coefficients morethan 0.9995.The limits of detection(LOD)were 0.0021μg for impurity A,0.0030μgfor impurity B,0.0045μg for impurity C and 0.0023μg for impurity D and the limits of qualification were 0.0071μg for impurity A,0.0099μg for impurity B,0.0150μg for impurity C and 0.0076μg for impurity D.The accuracies were good with the average recoveries of 99.74%for impurity A,101.22%for impurity B,101.17%for impurity C and 101.62%for impurity D.The method was accurate,sensitiveand suitable to measure the impurities in reducedglutathione.

关 键 词：谷胱甘肽 有关物质 高效液相 自身对照法 校正因子 

分 类 号：R917[医药卫生—药物分析学]