Abstract

OPTIMIZATION OF GC-HEADSPACE-TECHNOLOGY FOR ENHANCED DETECTION OF THE GENOTOXIC IMPURITY PROPIONALDEHYDE IN MELOXICAM

Deepak Kumar Nambiar and Divya Gairola*

ABSTRACT

Genotoxic impurities (GITs) are a significant regulatory concern in pharmaceuticals, and their detection and quantification necessitate the deployment of sensitive analytical techniques. A genotoxic impurity referred to as Propionaldehyde may arise during the production of active pharmaceutical ingredient (API) meloxicam and ought to be monitored within control. In this study, an optimized Gas Chromatography-Headspace (GC-HS) method for enhanced Propionaldehyde detection in meloxicam API is proposed. A PerkinElmer GC instrument with a DB-1 capillary column and a flame ionisation detector (FID) was executed. The method’s high specificity, linearity, accuracy, and precision were validated in accordance with ICH requirements (Q2 R1). The limits of quantification (LOQ) and detection (LOD) were 30.5 ppm and 10.2 ppm respectively. It has been demonstrated by batches of meloxicam API (n=3 batches) that noproduction batches encompassed Propionaldehyde. These outcomes demonstrate that GC-Headspace is a very successful, ethically acceptable method for detecting genotoxic impurities in medications of Meloxicam, guaranteeing product safety adherence to FDA and ICH M7 regulations.

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