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Determination of β-galactosidase in tablets by infrared spectroscopy

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Abstract

The infrared spectroscopy method using attenuated total reflectance and multivariate calibration to quantify β-galactosidase in tablets was developed and validated. The calibration step was developed using 66 calibration samples and 13 different samples in the validation process. The assay range was from 80 to 120%, and the excipients were microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, croscarmellose sodium, and crospovidone. The spectra were recorded in the range of 4000–400 cm−1 as the average of 128 scans. The optimised model was obtained using six PLS factors, and a root mean square error of prediction (RMSEP) of 1.2% and the correlation coefficient was 98%. The assay of validation samples was also compared with the official U.S. pharmaceutical test. The method was shown to be more rapid and reagent free and can be used as an alternative method to biopharmaceutical quality control.

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Acknowledgements

The authors gratefully acknowledge the financial support for this study provided by CAPES and FAPEMIG.

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Authors and Affiliations

  1. LACFAR—Laboratório de Análise e Caracterização de Fármacos, Institute of Chemistry, Federal University of Alfenas, Minas Gerais, 37130-000, Brazil

    Aline Gravinez Perissinato, Jerusa Simone Garcia & Marcello Garcia Trevisan

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  1. Aline Gravinez Perissinato
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  2. Jerusa Simone Garcia
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  3. Marcello Garcia Trevisan
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Correspondence to Marcello Garcia Trevisan.

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Perissinato, A.G., Garcia, J.S. & Trevisan, M.G. Determination of β-galactosidase in tablets by infrared spectroscopy. Chem. Pap. 71, 171–176 (2017). https://doi.org/10.1007/s11696-016-0107-2

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