便携式拉曼光谱法快速检测盐酸罗哌卡因注射液  

Rapid Determination of Ropivacaine Hydrochloride Injection by Portable Raman Spectroscopy

作　　者：徐代月 王静文[2] 刘万卉[1] 赵瑜[2] 陈华[2] Xu Daiyue;Wang Jingwen;Liu Wanhui;Zhao Yu;Chen Hua(School of Pharmacy,Collaborative Innovation Center of Ad-vanced Drug Delivery System and Biotech Drugs in Universities of Shandong,Key Laboratory of Molecular Pharmacology and Drug Evaluation(Yantai University),Ministry of Education,Yantai University,Shandong Yantai 264005,China;China Institutes for Food and Drug Control)

机构地区：[1]烟台大学新型制剂与生物技术药物研究山东省高校协同创新中心、分子药理和药物评价教育部重点实验室(烟台大学),山东烟台264005 [2]中国食品药品检定研究院

出　　处：《中国药师》2022年第5期937-941,共5页China Pharmacist

摘　　要：目的:利用便携式拉曼光谱仪,建立快速检测盐酸罗哌卡因注射液的方法。方法:将便携式拉曼光谱仪与化学计量学方法相结合,建立盐酸罗哌卡因注射液定性和定量模型。其中,定性模型用相关系数法进行建立;定量模型用PLS算法(包装为玻璃安瓿瓶)以及通过不同浓度的盐酸罗哌卡因拉曼光谱特征峰(680.9081 cm^(-1))结合标准曲线法(包装为玻璃以及聚丙烯安瓿瓶)进行建立。结果:9个厂家的24批样品定性结果均为“YES”;两种定量方法测定的盐酸罗哌卡因注射液含量均在95%~105%之间,与HPLC值相比较,相对偏差均在5%以内。结论:本方法测定简单,操作方便,可用于盐酸罗哌卡因注射液定性和定量检测。Objective:To establish a rapid detection method for ropivacaine hydrochloride injection by using a portable Raman spectrometer.Methods:The qualitative and quantitative models of ropivacaine hydrochloride injection were established by using a portable Raman spectrometer combined with chemometrics.The qualitative model was established by correlation coefficient;the quantitative model was established by the PLS algorithm(packaged in glass ampoules)and the Raman spectrum characteristic peaks of ropivacaine hydrochloride(680.9081 cm^(-1))at different concentrations in combination with the standard curve method(packaged in glass and polypropylene ampoules).Results:The qualitative results of 24 batches of samples from 9 manufacturers were all“YES”;the content of ropivacaine hydrochloride injection determined by the two quantitative methods was between 95%and 105%.The relative deviation values were within 5%compared with the HPLC values.Conclusion:This method is simple,and can be used easily for the qualitative and quantitative detection of ropivacaine hydrochloride injection.

关 键 词：拉曼光谱法 盐酸罗哌卡因注射液 定性模型 定量模型 

分 类 号：R917[医药卫生—药物分析学]