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O-cresol Concentration Online Measurement Based On Near Infrared Spectroscopy Via Partial Least Square Regression

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Published on: November 8, 2019

API determination by NIR spectroscopy across pharmaceutical production process.

M Blanco¹, M Bautista, M Alcalà

¹Departament de Química, Unitat de Química Analítica, Universitat Autònoma de Barcelona, Bellaterra, 08193 Barcelona, Spain. marcel.blanco@uab.es

AAPS Pharmscitech

|November 15, 2008

Summary

This summary is machine-generated.

Near-infrared (NIR) spectroscopy accurately quantifies active pharmaceutical ingredients in solid formulations. This method offers a faster alternative for monitoring drug production processes like granulation and tablet coating.

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UV-Vis Spectroscopic Characterization of Nanomaterials in Aqueous Media

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Area of Science:

Pharmaceutical Sciences
Analytical Chemistry
Spectroscopy

Background:

Quantitative analysis of active pharmaceutical ingredients (APIs) is crucial for drug production.
Traditional analytical methods can be time-consuming and labor-intensive.
Near-infrared (NIR) spectroscopy offers a potential rapid and non-destructive analytical technique.

Purpose of the Study:

To evaluate the efficacy of reflectance near-infrared (NIR) spectroscopy for quantitative analysis of an API.
To demonstrate NIR spectroscopy's applicability in different stages of solid pharmaceutical formulation production.
To compare NIR spectroscopy with conventional analytical methods for process monitoring.

Main Methods:

Development of calibration samples by mixing pure drug, excipients, and batch samples.
Preparation of samples with active ingredient concentrations ranging from 75-120 mg/g.
Utilizing partial least squares (PLS) regression in second-derivative mode for spectral analysis.
Employing a wavelength range of 1,134-1,798 nm for NIR data acquisition.

Main Results:

Accurate quantification of the active ingredient was achieved after granulation and tablet coating.
Prediction errors for granulated samples were 1.01%, and for tablets were 1.63%.
The developed NIR method demonstrated high precision and reliability.

Conclusions:

Reflectance NIR spectroscopy is a viable and accurate method for quantitative analysis of APIs in solid formulations.
NIR spectroscopy provides a rapid and efficient alternative to traditional methods for pharmaceutical process monitoring.
The study validates NIR spectroscopy for in-process control in drug manufacturing.