Identification of oral hypoglycemic APIs by NIR spectroscopy with scaling to the first range method

Dalian Ligong Daxue Xuebao/Journal of Dalian University of Technology(2012)

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摘要
The aim of this research is to develop a rapid,accurate and no sample preparation required method to identify 8 kinds of oral hypoglycemic active pharmaceutical ingredient(API)(solid and liquid) by using near infrared(NIR) spectroscopy.64 NIR spectra are utilized to establish the calibration model and rest 32 spectra are utilized to validate the performance of the model.On the original data,the first derivative combined with scaling to the first range method is conducted as the optimum pre-processing method at 12 072.3-4 000.0 cm-1,and 8 oral hypoglycemic APIs can be well identified by this model.With this approach,no ″error determinations″ are assigned to a wrong class,which indicates that the NIR method is appropriate for fast identification of oral hypoglycemic APIs in the inspection and acceptance before manufacture and warehousing of drug products in the pharmaceutical industry.
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关键词
Near infrared spectroscopy,Oral hypoglycemic APIs,Process analytical technology,Qualitative analysis,Scaling to the first range method
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