Development and validation of hplc-dad method for diclofenac sodium assay from new orodispersible tablets with co-processed excipients

Abstract

The aim of this study is to develop and validate a reliable, fast, and precise High-performance liquid chromatography (HPLC) method for the assay of diclofenac sodium (DIC) from previously optimized new orodispersible tablets (ODTs) developed with co-processed excipients.The method was conducted on an HPLC Agilent 1200, Zorbax C18 column, mobile phase of orthophosphoric acid solutions 0.1%, acetonitrile and methanol in the ratio (40:50:10 v/v/v) with a flow rate of 1.5 mL/min with isocratic elution and a total run time of 5 min. Detection of diclofenac sodium was carried out at 276 nm. The method was validated for linearity, precision, accuracy, robustness as per international guidelines. The developed method was found to be accurate, precise, fast, without interference from the co-processed excipients and can be useful for routine quality control analysis of diclofenac sodium in ODTs.