Develop and Validate a Stability-Indicating HPLC Assay Method for Paracetamol, and parabens in Pharmaceutical Dosages

Abstract

The drug's stability, which is a prerequisite for good drug quality, cannot be simply established unless a reliable and trustworthy method for demonstrating stability is applied.   Creating such a method is a challenging task. In this work, we developed and validated a reversed-phase stability indicating liquid chromatographic technique with photo diode-array detection to analyze paracetamol (PCM), methylparaben (MP), propylparaben (PP), and their degradants in commercial oral suspension.  The compounds and their degradants were separated using a Phenomenex C8 column (250 mm x 4.6 mm, 5 µm) and a mobile phase of pH 4 consisting acetonitrile, potassium di-hydrogen ortho-phosphate, tri-ethylamine, and glacial acetic acid in a 40:58:1.5:0.5 ratio, at 1.2 mL/min. All chemicals separated in within 12 min.  The developed method followed the guidelines of the International Conference on Harmonization (ICH) and fulfilled all its requirements in terms of linearity, recovery, reproducibility, detection, and quantitation limits. The dependability of the developed method was shown by recoveries of 98.88% to 101.80% in 102 samples from 34 batches, indicating that it can be used in quality control step for paracetamol, methylparaben, and propylparaben in oral suspension products.