Qualitative and quantitative analysis of metronidazole injection solutions by confocal microprobe Raman spectroscopy
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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(pH 1~12)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pH 12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(1 mg/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)。Abstract: Objective To explore the application of Raman spectroscopy in metronidazole injection solution analysis. Methods 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 differences 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 prediction, and the concentrations found from Raman and UV spectrometry showed no significant differences according to t-test (α=0.05).
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