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目的 :系统考察和评价褶合光谱法在药物及其制剂质量分析中的功能特性。方法 :将褶合光谱法应用于药物稳定性试验、杂质限量 (纯度 )检查、背景干扰下的单组分定量、双组分定量 ,并与常规的分析方法比较。结果与结论 :测定结果与常规分析方法一致 ,褶合光谱法克服了传统分光光度法在药物稳定性测定、杂质限量 (纯度 )检查中的局限性 ,并能不经分离对组分已知但存在背景干扰或光谱严重重叠的混合物进行准确定量 ,自动化程度较高
OBJECTIVE: To systematically investigate and evaluate the functional properties of convolution spectrometry in the quality analysis of drugs and their preparations. Methods: Convolution spectrometry was applied to drug stability test, impurity limit (purity) check, single component quantitative and two component quantitative analysis under background interference, and compared with conventional analytical methods. RESULTS AND CONCLUSION: The results of the assay are in accordance with the conventional analytical methods. Convolution spectrometry overcomes the limitations of conventional spectrophotometry in the determination of drug stability and impurities (purity) The presence of background interference or spectral overlap of the mixture for accurate quantification, a high degree of automation