Measurement uncertainty of lactase-containing tablets analyzed with FTIR

Abstract

Uncertainty is one of the most critical aspects in determination of measurement reliability. In order to ensure accurate measurements, results need to be traceable and uncertainty measurable. In this study, homogeneity of FTIR samples is determined with a combination of variographic and multivariate approach. An approach for estimation of uncertainty within individual sample, as well as, within repeated samples is introduced. FTIR samples containing two commercial pharmaceutical lactase products (LactaNON and Lactrase) are applied as an example of the procedure. The results showed that the approach is suitable for the purpose. The sample pellets were quite homogeneous, since the total uncertainty of each pellet varied between 1.5% and 2.5%. The heterogeneity within a tablet strip was found to be dominant, as 15-20 tablets has to be analyzed in order to achieve <5.0% expanded uncertainty level. Uncertainty arising from the FTIR instrument was <1.0%. The uncertainty estimates are computed directly from FTIR spectra without any concentration information of the analyte.

Keywords: FTIR; Principal component analysis; Spectral data; Total uncertainty; Variographic analysis.