Determination of β-galactosidase in tablets by infrared spectroscopy
- 73 Downloads
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.
Keywordsβ-Galactosidase Quality control Multivariate calibration PLS
The authors gratefully acknowledge the financial support for this study provided by CAPES and FAPEMIG.
- CRN, ETA (2013) Best practices guide: enzyme dietary supplement products. Washington, D.C., USA: Council for Responsible Nutrition and Enzyme Technical Association. http://www.crnusa.org/pdfs/CRN-ETA-BPG-Enzymes2013.pdf. Accessed 5 Mar 2016
- Diekmann L, Pfeiffer K, Naim HY (2015) Congenital lactose intolerance is triggered by severe mutations on both alleles of the lactase gene. BMC Gastroenterol 15. doi: 10.1186/s12876-015-0261-y (article no. 36)
- EMA (1995) Validation of analytical procedures. European Medicines Agency, London. http://www.ema.europa.eu/. Accessed 5 Mar 2016
- Hubert P, Nguyen-Huu JJ, Boulanger B, Chapuzet E, Chiap P, Cohen N, Compagnon PA, Dewé W, Feinberg M, Lallier M, Laurentie M, Mercier N, Muzard G, Nivet C, Valat L, Rozet E (2007) Harmonization of strategies for the validation of quantitative analytical procedures: a SFSTP proposal—part II. J Pharm Biomed Anal 45:70–81. doi: 10.1016/j.jpba.2007.06.013 CrossRefGoogle Scholar
- Mantanus J, Ziémons E, Lebrun P, Rozet E, Klinkenberg R, Streel B, Evrard B, Hubert P (2010) Active content determination of non-coated pharmaceutical pellets by near infrared spectroscopy: method development, validation and reliability evaluation. Talanta 80:1750–1757. doi: 10.1016/j.talanta.2009.10.019 CrossRefGoogle Scholar
- Mattar R, Monteiro MS, Villares CA, Santos AF, Silva JMK, Carrilho FJ (2009) Frequency of LCT-13910C>T single nucleotide polymorphism associated with adult-type hypolactasia/lactase persistence among Brazilians of different ethnic groups. Nutr J 8. doi: 10.1186/1475-2891-8-46 (article no. 46)
- Silva FEB, Ferrão MF, Parisotto G, Müller EI, Flores EMM (2009) Simultaneous determination of sulphamethoxazole and trimethoprim in powder mixtures by attenuated total reflection-Fourier transform infrared and multivariate calibration. J Pharm Biomed Anal 49:800–805. doi: 10.1016/j.jpba.2008.12.011 CrossRefGoogle Scholar
- U.S. Pharmacopeial Convention (2005) The United States pharmacopeia and the national formulary (USP–NF). U.S. Pharmacopeial Convention, RockvilleGoogle Scholar