ABSTRACT

This scholarly inquiry delineates the conceptualization and substantiation of an economically judicious ultra-high performance liquid chromatography (UPLC) methodology, meticulously fashioned in concordance with the stringent criteria delineated by the International Conference on Harmonization (ICH), meticulously tailored for the precise quantification of acetate moieties within the compound Flecainide Acetate. The procedural instantiation leverages an intricately configured UPLC system, harnessing the unique attributes of an innovative chromatographic column and a meticulously optimized mobile phase composition. The developmental trajectory of the methodology involved a methodical optimization of chromatographic parameters, meticulously calibrated to yield an elevated echelon of separation, resolution, and acuity in the quantification of acetate entities. The method, under scrutiny, manifested a linear response within the delimited span of 50% to 200%, fortified by an exceptionally elevated correlation coefficient of unity (1.000). The method evinced commendable accuracy and precision, ascertained through a percentage recovery spectrum spanning from 100.5% to 101.7%, and a percentage relative standard deviation (%RSD) consistently residing beneath the 2% threshold, thereby adhering meticulously to the exacting standards elucidated by the ICH. Rigorous evaluations of robustness and ruggedness proffered favorable outcomes, thereby corroborating the method's inherent reliability. A salient observation of paramount import was the absence of any discernible interference from excipients, underscoring the method's discerning accuracy and precision. This novel UPLC instantiation, meticulously attuned to the tenets of the ICH, proffers a pragmatic and fiscally frugal modality for the determination of acetate content within Flecainide Acetate, positing itspertinence for routine analyses in both bulk and pharmaceutical formulations of the aforementioned compound. Keywords: Flecainide Acetate, Acetate, International Conference on Harmonization (ICH), Ultra Performance Liquid Chromatography (UPLC), Validation
Publication date: 01/01/2026

https://ijbpas.com/pdf/2026/January/MS_IJBPAS_2026_9755.pdf

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https://doi.org/10.31032/IJBPAS/2026/15.1.9755