卡贝缩宫素注射液有关物质检测方法的建立与验证  

Establishment and validation of the determination method for the related substances in carbetocin injection

作　　者：陈一淼 张翔 吴锦慧[1] 黄玉晔 CHEN Yimiao;ZHANG Xiang;WU Jinhui;Huang Yuye(Medical School,Nanjing University,Nanjing 210093;Changzhou Siyao Pharmaceutical Co.,Ltd.,Changzhou 213004,China)

机构地区：[1]南京大学医学院,南京210093 [2]常州四药制药有限公司,常州213004

出　　处：《中国药科大学学报》2025年第1期65-72,共8页Journal of China Pharmaceutical University

摘　　要：建立一种HPLC分析方法用于卡贝缩宫素注射液中有关物质的测定。采用Waters Xbridge C18色谱柱(150 mm×3 mm,3.5μm),0.30 mg/mL乙酸铵-19%乙腈水溶液为流动相A,流动相A-乙腈(1∶1)为流动相B,检测波长为220 nm,在60℃的柱温下,以0.8 mL/min的流速进行梯度洗脱。对该方法的系统适用性、专属性、线性及范围、准确度等进行了验证,结果表明卡贝缩宫素注射液的9个杂质在各自浓度范围内与峰面积呈现良好的线性关系(R2>0.999),该方法的精密度良好(RSD<5%)。本法适用于同时检测卡贝缩宫素注射液中药物及其9个杂质,可为该制剂的质量控制提供理论依据。An HPLC analytical method was developed to determine the related substances in carbetocin injection.The method was performed on a Waters Xbridge C18 column(150 mm×3 mm,3.5μm)with 0.30 mg/mL ammonium acetate-19% acetonitrile aqueous solution as mobile phase A and mobile phase A-acetonitrile(1∶1)as mobile phase B.The detection wavelength was 220 nm.Gradient elution was performed at the flow rate of 0.8 mL/min and the column temperature of 60℃.The method was validated for system applicability,specificity,linearity and range,accuracy,with the results that the 9 impurities of carbetocin injection showed good linearity(R^(2)>0.999)with peak area in their respective concentration range,and that the method had good precision(RSD<5%).This method is suitable for the simultaneous determination of carbetocin and its 9 impurities in carbetocin injection and can provide a theoretical basis for the quality control of the carbetocin injection.

关 键 词：卡贝缩宫素注射液 有关物质 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]