Abstract
In this study, a new, green analytical method is proposed for the determination of N-acetylcysteine (NAC) in pharmaceutical formulations. The analyte was separated from the samples matrix using a 100% aqueous mobile phase [0.05% v/v CH3COOH+1 mmol L−1 ethylenediaminetetraacetic acid (EDTA) in water] and a suitable analytical column (Prevail reversed phase column). Detection was carried out at 285nm after on-line post-column derivatization (PCD) with methyl-propiolate (MP) in alkaline medium. Method development included both chromatographic and reaction parameters, while validation was based on international recommendations. The developed analytical scheme excludes the use of organic modifiers from all steps of pretreatment/analysis and offers adequate figures of merit for the quality control (assay and content uniformity) of NAC-containing formulations.
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