Quantification of API content in pharmaceutical tablets within milliseconds by time-stretch near-infrared transmission spectroscopy

J Pharm Biomed Anal. 2024 Oct 15:249:116372. doi: 10.1016/j.jpba.2024.116372. Epub 2024 Jul 20.

Abstract

We explored the feasibility of high-speed and high-accuracy quantification of active pharmaceutical ingredient (API) content in tablet products by near-infrared (NIR) spectroscopy to improve the reliability of pharmaceuticals. For this purpose, we employed a high-power NIR time-stretch transmission spectrometer recently developed by us. By using this transmission spectrometer with a multivariate calibration model, we demonstrated the ability to quantify API content with a short measurement time of 3.9 ms per tablet for model pharmaceuticals. For the model tablet, the quantification ability of our spectrometer was comparable to that achieved by a commonly used Fourier-transform NIR (FT-NIR) spectrometer with a measurement time of several seconds. We also confirmed that the effect of irradiating tablets with the NIR pulses used in our spectrometer was negligible.

Keywords: API content; High-speed measurement; Near-infrared spectroscopy; Pharmaceutical tablets; Time-stretch spectroscopy; Transmission spectroscopy.

MeSH terms

  • Calibration
  • Pharmaceutical Preparations / analysis
  • Pharmaceutical Preparations / chemistry
  • Reproducibility of Results
  • Spectroscopy, Fourier Transform Infrared / methods
  • Spectroscopy, Near-Infrared* / methods
  • Tablets* / chemistry
  • Time Factors

Substances

  • Tablets
  • Pharmaceutical Preparations