ISSN print edition: 0366-6352 ISSN electronic edition: 1336-9075 Registr. No.: MK SR 9/7 Published monthly

Determination of β-galactosidase in tablets by infrared spectroscopy

Aline Gravinez Perissinato, Jerusa Simone Garcia, and Marcello Garcia Trevisan

LACFAR—Laboratório de Análise e Caracterização de Fármacos, Institute of Chemistry, Federal University of Alfenas, Minas Gerais, Brazil

E-mail: mgtrevisan@gmail.com

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

Full paper is available at www.springerlink.com.

DOI: 10.1007/s11696-016-0107-2

Chemical Papers 71 (1) 171–176 (2017)