A simple and rapid chromatographic method for determination of naproxen and nabumetone in tablets

Abstract

AbstractA simple, rapid, and cost‐effective chromatographic method for determination of naproxen and nabumetone using a guard column was developed. Factors affecting separation (i.e., types of stationary phase and types and compositions of mobile phase) were optimized. Naproxen and nabumetone were completely resolved (Rs > 2.0) on a C18 guard column (10 × 4.0 mm, 5 μm) in 5 min using a mobile phase consisting of 2% v/v acetic acid (in water) and acetonitrile (75:25 v/v). Method validation was performed in terms of specificity, range, linearity, precision, and accuracy. The method showed a linear relationship (r2 > 0.999) in a range of 2–30 μg/mL, good precision (%RSD < 0.97), accuracy (%recovery of 98.8–100.5%), and specificity (peak purity indices >99%) for the determination of naproxen and nabumetone. The method was applied for quantitation of naproxen and nabumetone in tablets. Results were complied with the United State Pharmacopeia 2021 limits (90.0–110.0 and 95.0–105.0% for naproxen and nabumetone, respectively). The use of the guard column proved to be efficient, fast, and economical due to less solvent consumption and waste production. In addition, this approach benefits the quality control of pharmaceuticals in less industrial countries with limited resources.