RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ASSAY OF DICLOFENAC IN PHARMACEUTICAL FORMULATIONS

Abstract

Background: Diclofenac is a widely used non-steroidal anti-inflammatory drug (NSAID) formulated as tablets, injections, and topical dosage forms. Because diclofenac products are frequently manufactured by multiple producers and are prone to stability challenges under certain conditions (e.g., light/oxidation, pH effects), a reliable chromatographic method is essential for routine quality control.
Objective: To develop and validate a rapid, accurate, and precise RP-HPLC method for quantification of diclofenac in pharmaceutical formulations in accordance with ICH Q2(R1) principles.
Methods: Separation was achieved using a C18 column (250 × 4.6 mm, 5 µm) under isocratic elution with a buffered aqueous phase and acetonitrile. UV detection was performed at 276 nm. Method performance was evaluated through linearity, accuracy, precision, robustness, sensitivity, solution stability, and system suitability tests.
Results: The developed method produced a well-resolved diclofenac peak with consistent retention time and acceptable peak symmetry. The assay method demonstrated suitable linearity, accuracy, precision, and robustness for routine analysis across different formulation matrices.
Conclusion: The validated RP-HPLC method is suitable for routine quality control of diclofenac in common pharmaceutical dosage forms (e.g., tablets and topical gel), providing reproducible and reliable quantification with short run time.