左乙拉西坦注射液中有关物质HPLC测定方法的建立  

Establishment of HPLC Method for the Determination of Related Substances in Levetiracetam Injection

作　　者：丁极武 李恩澳 陆荣政 刘荣华[1] DING Jiwu;LI Enao;LU Rongzheng;LIU Ronghua(College of Pharmacy,Jiangxi University of Chinese Medicine,Nanchang 330004,China;Nanjing Zhengke Pharmaceutical Co.,Ltd.,Nanjing 210000,China)

机构地区：[1]江西中医药大学药学院,江西南昌330004 [2]南京正科医药股份有限公司,江苏南京210000

出　　处：《山东化工》2025年第2期153-156,159,共5页Shandong Chemical Industry

摘　　要：目的:建立左乙拉西坦注射液中有关物质的HPLC测定方法,并进行方法学验证。方法:Dikma Platisil ODS色谱柱(柱长250 mm,内径4.6 mm,粒径5μm),以质量分数0.1%磷酸水溶液为流动相A,乙腈为流动相B,梯度洗脱,紫外检测器检测,流速1.0 mL/min,检测波长205 nm,柱温30℃,进样量20μL。结果:左乙拉西坦与杂质分离度好;方法学验证结果均符合要求。结论:本方法专属性强,灵敏度高,耐用性好,可用于左乙拉西坦注射液有关物质的测定。Purpose:An HPLC method for the determination of related substances in levetiracetam injection was established and the method was verified.Methods:Dikma Platisil ODS column(length 250 mm,diameter 4.6 mm,particle size 5μm),with 0.1%phosphoric acid aqueous solution as mobile phase A and acetonitrile as mobile phase B,gradient elution,Ultraviolet detector detection,the flow rate was 1.0 mL/min,the detection wavelength was 205 nm,the column temperature was 30℃,and the sample size was 20μL.Result:Levetiracetam is well separated from impurities.The results of methodology verification meet the requirements.Conclusion:The HPLC method has strong specificity,high sensitivity and good durability,and can be used for the determination of related substances in levetiracetam injection.

关 键 词：HPLC法 左乙拉西坦注射液 有关物质 方法学验证 

分 类 号：TQ460[化学工程—制药化工]