Using Near-Infrared Spectrophotometry for the Identification of Pharmaceuticals and Drugs

Abstract

The near infrared range (NIR) of the electromagnetic spectrum extends from 800 to 2500 nm, being confined between the middle IR and visible spectral regions. The method of NIR spectroscopy is based on a combination of spectrophotometry and statistical methods of multifactor analysis, which provides excellent possibilities for drug identification and quality control even without opening the package. We have studied a series of drugs including cefazolin sodium and generic drugs based on enalapril maleate. True and falsified variants of a given drug X were classified into groups according to “drug name,” “drug manufacturer,” and “falsified product” by means of NIR spectroscopic analyses performed using the NIR Fourier-transform instruments Multi Purpose Analyzer (Bruker, Germany) and Antaris (Thermo Electron Corporation, USA). The potential of this method for the identification of drugs without violation of their packing shows good prospects for introducing it into the drug quality control system. This method should be recommended for introduction into the future Russian State Pharmacopoeia as a general method of drug analysis.