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Chemical Papers

, Volume 71, Issue 1, pp 171–176 | Cite as

Determination of β-galactosidase in tablets by infrared spectroscopy

  • Aline Gravinez Perissinato
  • Jerusa Simone Garcia
  • Marcello Garcia TrevisanEmail author
Original Paper

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.

Keywords

β-Galactosidase Quality control Multivariate calibration PLS 

Notes

Acknowledgements

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

Supplementary material

11696_2016_107_MOESM1_ESM.docx (84 kb)
Supplementary material 1 (DOCX 84 kb)

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Copyright information

© Institute of Chemistry, Slovak Academy of Sciences 2016

Authors and Affiliations

  • Aline Gravinez Perissinato
    • 1
  • Jerusa Simone Garcia
    • 1
  • Marcello Garcia Trevisan
    • 1
    Email author
  1. 1.LACFAR—Laboratório de Análise e Caracterização de Fármacos, Institute of ChemistryFederal University of AlfenasMinas GeraisBrazil

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