褶合光谱法在药物分析中的应用研究

Applied research of convolution spectrometry in pharmaceutical analysis

目的 系统考证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、光谱重叠的双组分定量 ,并与常规的分析方法比较。结果 测定结果与常规分析方法一致结果直观准确 ,自动化程度高。结论 本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 。

Objective To study systematically the function of convolution spectrometry in quality analysis of drugs and preparations.Methods Convolution spectrometry was applied in stability test,limit of impurity or purity test,quantitative analysis of individual and double components,and compared with routine method.Results The results of this method were consistent with these of routine method.Conclusions Convolution spectrome try overcomes the limitation of conventional spectrophotometry in stability and limit of impurity or purity test,and can assay preparations with interference without separation.The method is convenient,rapid,accurate and automated.