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A rapid and green RP-HPLC method for the simultaneous quantification of ketoprofen and famotidine: Development and validation

  • Universiti Sains Malaysia
  • Ajman University

Research output: Contribution to journalArticlepeer-review

Abstract

A simple, rapid, and environmentally friendly reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous determination of ketoprofen and famotidine in combined dosage forms. Chromatographic separation was achieved on a Roc C18 column (250 × 4.6 mm, 5 μm) using an isocratic mobile phase of methanol:water:acetonitrile (35:35:30, v/v/v) adjusted to pH 3.1 with formic acid, at a flow rate of 2 mL/min and detection at 264 nm. Retention times were 2.86 min for ketoprofen and 8.56 min for famotidine. The method was validated following ICH Q2(R2) guidelines, demonstrating excellent linearity (R2 = 0.9996 for ketoprofen, R2 = 0.9993 for famotidine), accuracy (98.35–101.26%), precision (%RSD < 1%), and sensitivity (LOD: 18.3 and 25 ng/mL; LOQ: 61.8 and 84 ng/mL, respectively). Robustness testing confirmed reliability under varied conditions. Importantly, the method minimizes solvent usage and employs short run times, aligning with green analytical chemistry principles. The proposed RP-HPLC method is precise, accurate, and suitable for routine quality control of ketoprofen–famotidine formulations, offering a sustainable alternative for pharmaceutical analysis.

Original languageEnglish
JournalActa Chromatographica
DOIs
StateAccepted/In press - 2026

Keywords

  • Eco-friendly Analysis
  • Famotidine
  • Green Analytical Chemistry
  • HPLC Method Validation
  • ICH Validation
  • ICH Validation
  • Ketoprofen
  • Method Development
  • Pharmaceutical Quality Control
  • RP-HPLC
  • Simultaneous Analysis

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