便携式拉曼光谱法快速检测西咪替丁注射液  

Rapid Identification and Determination of Cimetidine Injection by Portable Raman Spectroscopy

作　　者：蔡霞 杨仪雪 庄玥 CAI Xia;YANG Yixue;ZHUANG Yue(Guangdong Institute For Drug Control,NMPA Key Laboratory for Rapid Testing Technology of Drug,Guangzhou,Guangdong 510163,China)

机构地区：[1]广东省药品检验所,国家药品监督管理局药品快速检测技术重点实验室,广东广州510163

出　　处：《今日药学》2023年第7期545-547,共3页Pharmacy Today

基　　金：广东省医学科学技术研究基金项目(B2020185);广东省药品监督管理局科技创新项目(2021YDZ07)。

摘　　要：目的建立一种用便携式拉曼光谱技术快速检测西咪替丁注射液的方法。方法以西咪替丁注射液为研究对象,运用便携式拉曼光谱技术对西咪替丁注射液进行快速鉴别和含量测定,并与HPLC法进行比较。测定条件:激发波长785 nm,分辨率为4.5 cm^(-1),测试时间为100 s,最大激光输出功率为400 mW,扫描范围3200~200 cm^(-1)。结果西咪替丁质量浓度在1~25 mg·mL^(-1)范围内与2170 cm^(-1)峰位的峰面积呈良好的线性关系(r=0.9995),低、中、高3个浓度的平均回收率分别为97.3%、109.8%、108.7%,RSD分别为0.9%、0.8%、2.0%,6个批次样品西咪替丁含量测定结果分别为标示量的100.5%、97.2%、97.9%、100.4%、100.2%、103.2%,测定结果与HPLC法测定的结果经t检验证明差异无统计学意义。结论本方法快捷、简便,可用于西咪替丁注射液的快速检测。OBJECTIVE To established a method for the rapid determination ofcimetidine by using portable Raman spectroscopy.METHODS Portable Raman spectroscopy was used as the method of identification and determination of the cimetidine injection and compared with that determined by HPLC method.Determination conditions were as follows:the laser was 785 nm,the resolution was 4.5 cm^(-1),the test time was 100 s,the laser maximum output power was 400 mW,the scanning range was 3200-200 cm^(-1).RESULTS The calibration curve was linear over the range of 1-25 mg·mL^(-1)with peak area at 2170 cm^(-1)(r=0.9995).The average recoveries at low,medium and high concentration were 97.3%,109.8%,108.7%,with RSD of 0.9%,0.8%and 2.0%,respectively.Contents of cimetidine in 6 batches of samples were 100.5%,97.2%,97.9%,100.4%,100.2%and 103.2%of the labeled value.There was no significant difference between the determination results and the results with HPLC method by t-test.CONCLUSION The method is convenient and rapid,which can be used for the rapid identification and determination of cimetidine injection.

关 键 词：拉曼光谱法 西咪替丁注射液 快速检测 

分 类 号：R917[医药卫生—药物分析学]