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机构地区:[1]广西南宁食品药品检验所,南宁530001 [2]湖南省湘潭市食品药品检验所
出 处:《中国药师》2014年第10期1626-1628,1648,共4页China Pharmacist
基 金:"重大新药创制"科技重大专项(编号:2011ZX09303-001)
摘 要:目的:建立用拉曼光谱技术快速鉴别和测定加替沙星注射液的方法。方法:以加替沙星注射液为研究对象,运用拉曼光谱技术对加替沙星注射液进行快速鉴别和含量测定,测定条件:显微拉曼光谱仪,激发光波长:785 nm,物镜:50X,激光功率:3 mW,信号采集时间:60 s。结果:研究表明,拉曼光谱法可以鉴别加替沙星注射液,并能测定此类注射液中加替沙星含量分别为99.49%、97.56%、100.2%(规格:10 ml∶0.2 g)和97.75%、94.58%、96.25%(规格:2 ml:0.1 g),测定结果与HPLC法测定的结果差异无统计学意义(P>0.05)。结论:本方法操作简便、快速无损,可作为加替沙星注射液快速检测的分析方法。Objective:To develop a method for the rapid identification and determination of gatifloxacin injections by Raman spec-troscopy. Methods:Raman spectroscopy was used as the method of identifying and determining gatifloxacin injections. The determina-tion conditions were as follows:a micro Raman spectroscopy, excitation wavelength:785nm, objective lens:50X, laser power:3mW, signal acquisition time:60s. Results:The result showed that the Raman spectroscopy could identify and determine gatifloxacin injec-tions, the content of gatifloxacin in the injections was respectively 99. 49%,97. 56% and 100. 2%(Specification:10ml∶0. 2g), and 97. 75%, 94. 58% and 96. 25%(Specification:2ml∶0. 1g), and there was no significant difference between the above determination results and the results from the HPLC method by t-test. Conclusion:For the fast and nondestructive properties, the presented method can be developed as an analysis method for gatifloxacin injections.
关 键 词:加替沙星注射液 拉曼光谱 快速检测 鉴别 含量测定
分 类 号:R917[医药卫生—药物分析学]
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