Development and Validation of Novel GC-FID Method for Simultaneous Quantification of Paracetamol and Caffeine in Formulations

Abstract

The advancements in analytical techniques have enabled the development of highly sensitive and accurate methods for the identification of materials up to trace levels using microliter of sample. A highly sensitive and novel GC-FID method has been developed and reported herein for the simultaneous quantification of paracetamol (PCM) and caffeine (CAF) in samples up to trace levels. The method was validated as per ICH guidelines for its sensitivity, linearity, robustness, inter and intra-day variations, limit of quantification (LOQ), limit of detection (LOD), matrix effect, carryover, precision, and accuracy. The LOD of PCM and CAF were determined to be 100 ppm and 10 ppm whereas, LOQ of PCM and CAF were found to be 300 and 30 ppm respectively. The method was applied to quantify PCM and CAF in marketed tablets and dissolution samples of the tablets, which showed highly precise and accurate quantification of PCM and CAF. Moreover, the GC-FID method was compared with reported HPLC method which suggested the superiority of GC-FID method in performance and sensitivity. In short, the newly developed GC-FID method showed sensitivity and selectivity for PCM and CAF estimation and can be adopted as an efficient method for various applications.