Pharmaceutica Analytica Acta

Investigating the Feasibility of Mid-range Infrared Spectroscopic Analyzer (MIRA) for Quantification of Polysorbate 20

24^th Global Summit on Analytical and Bioanalytical Techniques

July 19-20, 2023 | Webinar

Ana F. S. Seica

Boehringer Ingelheim Pharma GmbH, Development Operations Germany, Analytical Development, Birkendorfer Str. 65 â?¢ 88400 Biberach

Scientific Tracks Abstracts: Pharm Anal Acta

Abstract:

The accurate quantification of polysorbate 20 in drug formulations is of critical importance in the pharmaceutical industry. In this study, the behaviour of PS20 with different buffers and a drug substance using mid-infrared spectroscopy was investigated. Multiple methods have been developed in recent years to analyse polysorbate components in drug products. Infrared spectroscopy (IR) has the potential to become one of the most important analytical technique available in industry nowadays. IR is a non-invasive and non-destructive technique that requires minimal sample preparation and provides a realtime response, provides qualitative and quantitative information in a fast, cost-effective way. In this study, the suitability of mid-infrared spectroscopy for quantifying PS20 in formulated drug substance and placebo formulations was evaluated. The analysis was performed using two characteristic bands of PS20, the stretching C=O region between 1720 - 1770 cm-1 and the C-O group from the ethyl moiety between 1050 - 1200 cm-1. The results of this study provide important insights into the use of IR as a method for quantifying PS20 in drug substance and the ability of this technique to detect changes accurately and sensitively in different sample matrices. IR was applied to determine the correlation between the absorption values of the C=O and the C-O-C band of PS20 and the nominal PS20 content. The study showed that the method is capable of quantifying PS20 as low as 0.04 g/L in the placebo buffer and 0.12g/L in drug substance with high accuracy, demonstrating the high resolution and reproducibility of the MIRA method. The percentage accuracy in quantifying PS20 using this method was found to be ≥ 90%, which demonstrate the potential of this method as a useful tool for the pharmaceutical industry, given its ability to accurately quantify PS20 in drug substances.

Biography :

Filipa Seica is a PostDoc at Boehringer Ingelheim, where she is responsible for implementing new technologies and processes in analytical development. Her role also involves safeguarding and expanding the company’s innovative state-of-the-art analytical capabilities. Filipa is an expert in vibrational spectroscopies, with a particular focus on infrared spectroscopy applied to biomolecules and proteins. She has extensive experience in the field, having completed her PhD in Chemistry at the University of Strasbourg, where she studied the structural and functional properties of proteins using infrared spectroscopy. Since joining Boehringer Ingelheim, Filipa has been instrumental in developing a new analytical method and techniques that can have the potential to improve the company’s ab ility to analyze and characterize complex biomolecules