Pharmaceutical gel analysis by NIR spectroscopy. Determination of the active principle and low concentration of preservatives.

M Blanco, M Alcalá, M Bautista
Author Information
  1. M Blanco: Departament de Química, Unitat de Química Analítica, Universitat Autònoma de Barcelona, E-08193 Bellaterra, Barcelona, Spain. marcel.blanco@uab.es

Abstract

Near infrared spectroscopy has proved highly suitable for the analysis of pharmaceutical formulations. However, its limited sensitivity can severely restrict its scope of application. In this work, we determine the active principle and two preservatives in a pharmaceutical preparation available as a hydrogel. The matrix of the pharmaceutical preparation exhibits strong absorption in the NIR spectral region; also, the two preservatives (parabens) are very similar in chemical and spectral terms, and present at low concentrations in the pharmaceutical. These complications make it rather difficult to accurately quantify the active principle and the preservatives, which can only be accomplished by using an effective design in order to prepare the samples to be included in the calibration set and select the optimum spectral range for measuring each analyte. The evaporation of solvents during the measurement process produces increasing errors related with sample's air exposition; the introductions of new samples with a wider range of the volatile components correct this effect. An ANOVA of the predictions obtained with the new models shows that correct the error due to evaporation. The proposed method was validated for the analytical control of the studied preparation.

MeSH Term

Calibration
Chemistry, Pharmaceutical
Hydrogels
Ketoprofen
Parabens
Pharmaceutical Preparations
Preservatives, Pharmaceutical
Sensitivity and Specificity
Spectroscopy, Near-Infrared

Chemicals

Hydrogels
Parabens
Pharmaceutical Preparations
Preservatives, Pharmaceutical
Ketoprofen
methylparaben
propylparaben

Word Cloud

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