HPLC法测定盐酸丁咯地尔注射液中的杂质及含量  

Analysis of Buflomedil Hydrochloride Injection by HPLC

作　　者：冯继承 于芳 Feng Jicheng(Center For Food and Drug Inspection of Heilongjiang Province)

机构地区：[1]黑龙江省食品药品审核查验中心,哈尔滨150076 [2]黑龙江迪龙制药有限公司,哈尔滨150070

出　　处：《黑龙江医药》2018年第1期4-7,共4页Heilongjiang Medicine journal

摘　　要：目的:建立HPLC法测定盐酸丁咯地尔注射液的含量及杂质。方法:用C_(18)烷基硅烷键合硅胶为填充剂;CH_3OH-H_2O-CH_3COOH-(C_2H_5)_3N(250:300:0.8:1.0)为流动相;检测波长为282nm。按盐酸丁咯地尔峰计算理论塔板数,理论塔板数应不低于2000。结果:盐酸丁咯地尔注射液溶液稳定性RSD为0.4%(n=6);重复性试验RSD为0.6%(n=6);回收率为99.3%,0.74%(n=3)最低检测限为0.005μg/ml。结论:该方法对于盐酸丁咯地尔注射液的含量及杂质具有专属性好,简捷、快速,灵敏度高,重现性好的优点。Objective:To establish a HPLC method for determination of Buflomedil Hydrochloride Injection and its impurities.Methods:HPLC was established with MeOH-H2〇-HOAc-TEA(250:300:0.8:1.0).The detection wavelength is 282ran,The theoretical plate number should be no less than 2000 under the Buflomedil Hydrochloride peak.Results:The reproducibility test RSD was 0.6%(n=6),the recovery rate was 99.3%,0.74%(n=3),and the minimum detection limit was 0.005[ig/ml.Conclusion:The method has the advantages of good specificity,simplicity,high speed,high sensitivity and good reproducibility for the content and impurity of Buflomedil Hydrochloride Injection.

关 键 词：盐酸丁咯地尔注射液 HPLC法 含量及杂质检测 

分 类 号：R927.2[医药卫生—药学]