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近红外光谱分析法以其快速、无损、样品几乎无需处理、信息丰富等优点在制药领域得到了广泛应用。在方法开发的生命周期中,分析方法需要经过规范的验证才能投入使用,而目前对于近红外光谱分析法的具体实验性验证尚无明确的标准与判别指标,各类文献报道中采用了不同的方式对近红外光谱分析法进行了评估与验证。该文对药学领域近红外光谱定量分析法的验证进行综述,对现有的相关标准文件内容与主要的验证思路进行分析、讨论,为近红外光谱分析技术在药学领域的规范应用提供参考。
Near infrared spectroscopy has been widely used in the pharmaceutical field due to its advantages such as rapid, non-destructive, almost no processing of samples, abundant information and so on. In the life cycle of the method development, the analytical method needs to go through the standard verification before it can be put into use. At present, there is no clear standard and discriminant index for the specific experimental verification of near infrared spectroscopy. Different types of literature reports use different Methods of near infrared spectroscopy were evaluated and verified. In this paper, the verification of quantitative analysis of near infrared spectroscopy in pharmacy is reviewed. The contents of relevant standard documents and the main verification ideas are analyzed and discussed, which provide references for the application of near infrared spectroscopy in the field of pharmacy.