Application of chemometric modelling to UV-Vis spectroscopy: development of simultaneous API and critical excipient assay in a liquid solution continuous flow

Abstract

By applying Chemometric modelling to UV-Vis spectroscopy, a single Multi-Variate Data Analysis predictive model, for in-line monitoring of two component concentrations in solution formulation, was developed. The purpose of this article is to summarize the experimental development work performed for the UV-Vis analytical method and calibration modelling to determine the content of active pharmaceutical ingredient Carbetocin and the content of one critical excipient (l-methionine) in PABAL® solution for injection 100 µg/mL.

Keywords:

• Continuous liquid manufacturing
• chemometrics
• partial least square (PLS)
• UV spectroscopy
• Carbetocin
• L-Methionine
• content testing

Acknowledgements

The authors thank the Carl Zeiss Spectroscopy GmbH UV-Vis supplier for their support and the CAMO Analytics team for their guidance in modelling.

Disclosure statement

No potential conflict of interest was reported by the author(s).