HPLC法测定左乙拉西坦注射液中的右旋异构体  

Determination of the Dextro-rotatory Stereoisomer in Levetiracetam Injection by HPLC

作　　者：侯洪叶 王松松 苏磊 郑令娜 高永吉 HOU Hongye;WANG Songsong;SU Lei;ZHENG Lingna;GAO Yongji(Weifang Medical University,Weifang 261053;China Resources Double Crane Limin Pharmaceutical Co.,Ltd.,Jinan 250200)

机构地区：[1]潍坊医学院,山东潍坊261053 [2]华润双鹤利民药业(济南)有限公司,山东济南250200

出　　处：《中国医药工业杂志》2022年第12期1775-1779,共5页Chinese Journal of Pharmaceuticals

摘　　要：建立了HPLC法测定左乙拉西坦(1)注射液中的右乙拉西坦(2)。色谱柱采用CHIRALPAK IG柱(4.6 mm×250 mm,5μm),以直链淀粉-三(3-氯-5-甲基苯基氨基甲酸酯)为填充剂。流动相为10 mmol/L乙酸铵溶液∶乙腈(70∶30),等度洗脱;检测波长为190 nm,流速为0.7 ml/min,柱温为30℃,进样量为100μl。结果显示,在该色谱条件下2与1峰的分离度良好,2和1分别在0.4~8.0和0.8~8.0μg/ml内线性关系良好,检测限分为10、20 ng。2和1的平均回收率(n=9)分别为103.84%、99.10%,RSD分别为0.81%、1.16%。精密度试验、稳定性试验和重复性试验的RSD均小于2.0%,且耐用性良好。建立的方法简便、准确可靠、灵敏度高、重复性好,适用于1注射液中右旋体的质量控制。An HPLC method was established for the determination of R-isomer etiracetam(2)in levetiracetam(1)injection.A CHIRALPAK IG column(4.6 mm×250 mm,5μm)was used with amylose tri(3-chloro-5-methylphenyl carbamate)as filler.The analysis was carried out in the isocratic elution mode with 10 mmol/L ammonium acetate∶acetonitrile(70∶30)as the mobile phase.The detection wavelength was 190 nm,the flow rate was 0.7 ml/min,the column temperature was 30℃,and the injection volume was 100μl.The results showed that the separation between peaks of 2 and 1 was good under this chromatographic condition.It was linear for 2 and 1 in the ranges of 0.4-8.0 and 0.8-8.0μg/ml,respectively,and the detection limits of 2 and 1 were 10 and 20 ng,respectively.The average recoveries(n=9)of 2 and 1 were 103.84%and 99.10%,with the RSDs of 0.81%and 1.16%,respectively.The RSDs of precision test,stability test and repeatability test were all less than 2.0%,and the durability was good.The established method was simple,accurate,reliable,sensitive and reproducible,which was suitable for the quality control of dextro-rotatory stereoisomer in 1 injection.

关 键 词：高效液相色谱 左乙拉西坦注射液 质量控制 右旋异构体 右乙拉西坦 

分 类 号：R917[医药卫生—药物分析学]