Determination of the main solid-state form of albendazole in bulk drug, employing Raman spectroscopy coupled to multivariate analysis

Albendazole (ALB) is a broad-spectrum anthelmintic, which exhibits two solid-state forms (Forms I and II). The Form I is the metastable crystal at room temperature, while Form II is the stable one. Because the drug has poor aqueous solubility and Form II is less soluble than Form I, it is desirabl...

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Detalles Bibliográficos
Autores principales: Calvo, Natalia Lorena, Arias, Juan Marcelo, Ben Altabef, Aída, Maggio, Rubén Mariano, Kaufman, Teodoro Saúl
Formato: article artículo publishedVersion
Lenguaje:Inglés
Publicado: Elsevier 2020
Materias:
Albendazole
Chemometrics
PLS
Raman Spectroscopy
Solid State Forms
Acceso en línea:http://hdl.handle.net/2133/17590
http://hdl.handle.net/2133/17590
Aporte de:
Repositorio Hipermedial de la Universidad Nacional de Rosario (UNR) de Universidad Nacional de Rosario
id I15-R121-2133-17590
record_format dspace
institution Universidad Nacional de Rosario
institution_str I-15
repository_str R-121
collection Repositorio Hipermedial de la Universidad Nacional de Rosario (UNR)
language Inglés
orig_language_str_mv eng
topic Albendazole
Chemometrics
PLS
Raman Spectroscopy
Solid State Forms
spellingShingle Albendazole
Chemometrics
PLS
Raman Spectroscopy
Solid State Forms
Calvo, Natalia Lorena
Arias, Juan Marcelo
Ben Altabef, Aída
Maggio, Rubén Mariano
Kaufman, Teodoro Saúl
Determination of the main solid-state form of albendazole in bulk drug, employing Raman spectroscopy coupled to multivariate analysis
topic_facet Albendazole
Chemometrics
PLS
Raman Spectroscopy
Solid State Forms
description Albendazole (ALB) is a broad-spectrum anthelmintic, which exhibits two solid-state forms (Forms I and II). The Form I is the metastable crystal at room temperature, while Form II is the stable one. Because the drug has poor aqueous solubility and Form II is less soluble than Form I, it is desirable to have a method to assess the solid-state form of the drug employed for manufacturing purposes. Therefore, a Partial Least Squares (PLS) model was developed for the determination of Form I of ALB in its mixtures with Form II. For model development, both solid-state forms of ALB were prepared and characterized by microscopic (optical and with normal and polarized light), thermal (DSC) and spectroscopic (ATR-FTIR, Raman) techniques. Mixtures of solids in different ratios were prepared by weighing and mechanical mixing of the components. Their Raman spectra were acquired, and subjected to peak smoothing, normalization, standard normal variate correction and de-trending, before performing the PLS calculations. The optimal spectral region (1396–1280 cm−1) and number of latent variables (LV = 3) were obtained employing a moving window of variable size strategy. The method was internally validated by means of the leave one out procedure, providing satisfactory statistics (r2 = 0.9729 and RMSD = 5.6%) and figures of merit (LOD = 9.4% and MDDC = 1.4). Furthermore, the method’s performance was also evaluated by analysis of two validation sets. Validation set I was used for assessment of linearity and range and Validation set II, to demonstrate accuracy and precision (Recovery = 101.4% and RSD = 2.8%). Additionally, a third set of spiked commercial samples was evaluated, exhibiting excellent recoveries (94.2 ± 6.4%). The results suggest that the combination of Raman spectroscopy with multivariate analysis could be applied to the assessment of the main crystal form and its quantitation in samples of ALB bulk drug, in the routine quality control laboratory
format article
artículo
publishedVersion
author Calvo, Natalia Lorena
Arias, Juan Marcelo
Ben Altabef, Aída
Maggio, Rubén Mariano
Kaufman, Teodoro Saúl
author_facet Calvo, Natalia Lorena
Arias, Juan Marcelo
Ben Altabef, Aída
Maggio, Rubén Mariano
Kaufman, Teodoro Saúl
author_sort Calvo, Natalia Lorena
title Determination of the main solid-state form of albendazole in bulk drug, employing Raman spectroscopy coupled to multivariate analysis
title_short Determination of the main solid-state form of albendazole in bulk drug, employing Raman spectroscopy coupled to multivariate analysis
title_full Determination of the main solid-state form of albendazole in bulk drug, employing Raman spectroscopy coupled to multivariate analysis
title_fullStr Determination of the main solid-state form of albendazole in bulk drug, employing Raman spectroscopy coupled to multivariate analysis
title_full_unstemmed Determination of the main solid-state form of albendazole in bulk drug, employing Raman spectroscopy coupled to multivariate analysis
title_sort determination of the main solid-state form of albendazole in bulk drug, employing raman spectroscopy coupled to multivariate analysis
publisher Elsevier
publishDate 2020
url http://hdl.handle.net/2133/17590
http://hdl.handle.net/2133/17590
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