Quantitation of the active compound and major excipients in a pharmaceutical formulation by near infrared diffuse reflectance spectroscopy with fibre optical probe

M. Blanco; J. Coello; H. Iturriaga; S. Maspoch; C. De La Pezuela

doi:10.1016/0003-2670(96)00250-4

Quantitation of the active compound and major excipients in a pharmaceutical formulation by near infrared diffuse reflectance spectroscopy with fibre optical probe

M. Blanco, J. Coello, H. Iturriaga, S. Maspoch, C. De La Pezuela

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Abstract

A new method for analyses of a commercial pharmaceutical formulation based on near infrared diffuse reflectance spectroscopy (NIRRS) with fibre optical probe and using partial least-squares regression (PLS) for multivariate calibration is proposed. Analyses include the determination of the active compound and major excipients. The influence of the spectral mode and wavelength range used are studied. Satisfactory predictive results for production samples require calibration with laboratory-made samples covering the concentration range involved in the manufacturing process, as well as samples from various production batches, which introduce the variation sources inherent in such a process. The number of production samples to be used for calibration in order to ensure correct prediction of new production samples is discussed.

Original language	English
Pages (from-to)	147-156
Journal	Analytica Chimica Acta
Volume	333
Issue number	1-2
DOIs	https://doi.org/10.1016/0003-2670(96)00250-4
Publication status	Published - 30 Oct 1996

Keywords

Fibre optical probe
Near infrared spectroscopy
Pharmaceutical

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10.1016/0003-2670(96)00250-4

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title = "Quantitation of the active compound and major excipients in a pharmaceutical formulation by near infrared diffuse reflectance spectroscopy with fibre optical probe",

abstract = "A new method for analyses of a commercial pharmaceutical formulation based on near infrared diffuse reflectance spectroscopy (NIRRS) with fibre optical probe and using partial least-squares regression (PLS) for multivariate calibration is proposed. Analyses include the determination of the active compound and major excipients. The influence of the spectral mode and wavelength range used are studied. Satisfactory predictive results for production samples require calibration with laboratory-made samples covering the concentration range involved in the manufacturing process, as well as samples from various production batches, which introduce the variation sources inherent in such a process. The number of production samples to be used for calibration in order to ensure correct prediction of new production samples is discussed.",

keywords = "Fibre optical probe, Near infrared spectroscopy, Pharmaceutical",

author = "M. Blanco and J. Coello and H. Iturriaga and S. Maspoch and {De La Pezuela}, C.",

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T1 - Quantitation of the active compound and major excipients in a pharmaceutical formulation by near infrared diffuse reflectance spectroscopy with fibre optical probe

AU - Blanco, M.

AU - Coello, J.

AU - Iturriaga, H.

AU - Maspoch, S.

AU - De La Pezuela, C.

PY - 1996/10/30

Y1 - 1996/10/30

N2 - A new method for analyses of a commercial pharmaceutical formulation based on near infrared diffuse reflectance spectroscopy (NIRRS) with fibre optical probe and using partial least-squares regression (PLS) for multivariate calibration is proposed. Analyses include the determination of the active compound and major excipients. The influence of the spectral mode and wavelength range used are studied. Satisfactory predictive results for production samples require calibration with laboratory-made samples covering the concentration range involved in the manufacturing process, as well as samples from various production batches, which introduce the variation sources inherent in such a process. The number of production samples to be used for calibration in order to ensure correct prediction of new production samples is discussed.

AB - A new method for analyses of a commercial pharmaceutical formulation based on near infrared diffuse reflectance spectroscopy (NIRRS) with fibre optical probe and using partial least-squares regression (PLS) for multivariate calibration is proposed. Analyses include the determination of the active compound and major excipients. The influence of the spectral mode and wavelength range used are studied. Satisfactory predictive results for production samples require calibration with laboratory-made samples covering the concentration range involved in the manufacturing process, as well as samples from various production batches, which introduce the variation sources inherent in such a process. The number of production samples to be used for calibration in order to ensure correct prediction of new production samples is discussed.

KW - Fibre optical probe

KW - Near infrared spectroscopy

KW - Pharmaceutical

U2 - 10.1016/0003-2670(96)00250-4

DO - 10.1016/0003-2670(96)00250-4

M3 - Article

SN - 0003-2670

VL - 333

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EP - 156

JO - Analytica Chimica Acta

JF - Analytica Chimica Acta

IS - 1-2

ER -

Quantitation of the active compound and major excipients in a pharmaceutical formulation by near infrared diffuse reflectance spectroscopy with fibre optical probe

Abstract

Keywords

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