甲硝唑注射液共聚焦显微拉曼光谱法定性与定量分析  

Qualitative and quantitative analysis of metronidazole injection solutions by confocal microprobe Raman spectroscopy

作　　者：杨明华 孙雪妹 陈桂良[2] 张予敏[3] 

机构地区：[1]上海市浦东食品药品检验所,上海201203 [2]上海市食品药品检验所,上海201203 [3]上海市食品药品监督管理局,上海200010

出　　处：《药学实践杂志》2013年第4期273-276,共4页Journal of Pharmaceutical Practice

摘　　要：目的研究拉曼光谱在甲硝唑注射液定性、定量分析中的应用。方法分析甲硝唑注射液在酸性至碱性条件下（pH1～12）拉曼光谱的变化，并检测甲硝唑注射液中的有关物质2-甲基-5-硝基咪唑的含量。采用偏最小二乘法（PLS）和主成分回归法（PCR）对甲硝唑注射液进行定量，并将检测结果与紫外分光光度法进行比较。结果酸性条件下甲硝唑注射液在拉曼光谱图上有明显差别，碱性条件下，差异不明显，但在pH12以上甲硝唑注射液变为暗红色。由于2-甲基-5-硝基咪唑在甲硝唑注射液中的浓度过低（1mg／L），因此拉曼光谱图中无法检测到它的存在。结论PLS和PCR两种方法在甲硝唑注射液的定量上都能得到满意的结果。拉曼光谱与紫外分光光度法得出的含量测定结果，根据t检验，没有显著差异（α=0．05）。Objective To explore the application of Raman spectroscopy in metronidazole injection solution analysis. Meth- ods The variation of metronidazole （MET） injections＇ Raman spectra was analyzed when the pH varied from 1 to 12, and the related substances （2-methyl-5-nitroimidazole） in MET injection were detected. Two quantitative analysis techniques, multivariate partial least squares （PLS） and principal component regression （PCR） were compared in MET sample quantification. The quantification results of commercial MET injection product were compared with pharmacopoeias suggested UV Spectrometry method. Results The pH differ- ences were reflected in Raman spectra. Because of the low concentration of the related substance in Commercial MET injection （ 1 mg/ L） , the related substance could not be detected by Raman spectrum. Conclusion Both PLS and PCR could reach satisfactory predic- tion, and the concentrations found from Raman and UV spectrometry showed no significant differences according to t-test （ α = 0.05）.

关 键 词：拉曼光谱 甲硝唑注射液 定性分析 定量分析 

分 类 号：R917[医药卫生—药物分析学]