[Research progress on method validation of near infrared spectroscopy in quantitative analysis]

Due to the advantages of fast and noninvasive, requiring almost no sample preparation, supplying chemical and physical information, near infrared (NIR) spectroscopy is widely used in the pharmaceutical industry. In the life cycle of an established analytical method, rigorous validation should be performed before routine use. However,there is no detailed experimental standards or decision rules for the NIR methods validation currently, and various approaches were applied to validate the established NIR quantification models in literatures.In this paper, progress on the validation of NIR methods developed for the pharmaceutical application was reviewed, concentrating on the standard documents and main ideas of validation.It will provide references for the standardized application of NIR spectroscopy in the pharmaceutical industries.