A Simple Stability-Indicating UPLC Method for the Concurrent Assessment of Paracetamol and Caffeine in Pharmaceutical Formulations

A fixed-dose combination of paracetamol (PCM) and caffeine (CAF) tablets/capsules is the most frequently used over-the-counter medicine for fever headache. In this paper, a simple, reliable, sensitive, rapid, stability-indicating ultra-performance liquid chromatography (UPLC) analytical method was proposed simultaneously assessing PCM CAF in pharmaceutical formulations. The UPLC developed on an Acquity UPLC® CSHTM C18 column, column oven temperature maintained at 35 ± 5 °C with isocratic elution by using solution methanol water (30:70, v/v). maximum absorbance observed 272.5 nm. flow rate 0.2 mL/min, injection volume 1 µL, total run time 2 min separation CAF. validated according to ICH guidelines, it demonstrated excellent linearity, correlation coefficients 0.9995 0.9999 over concentration ranges 40–400 7–70 ng/mL CAF, respectively. mean retention times 0.82 0.0 1.16 0.02 were limits detection quantification 16.62 3.86 PCM, respectively, 50.37 11.70 subjected acidic, alkali, oxidative, phytochemical, dry-heat, wet-heat degradation. found well separate analytes’ peaks from degradation peaks, no alterations times. linear, precise, accurate, specific, robust, can indicate stability be quantitative assessment formulations comprising within short period time.