Optimization and Validation of a method for Simultaneous Determination of Amoxicillin and Clavulanic acid by HPLC in Different Pharmaceutical Forms

Abstract

A simple, fast, economical, accurate, precise and reproducible RP – HPLC method with ultraviolet detection at 220 nm has been validated for the simultaneous determination of Amoxicilline and Clavulanique acid. A good chromatographic separation between both compounds was achieved using a reversed phase C18 column and a mobile phase, consisting of Acetonitril / NaH₂PO₄.buffer pH = 4.4). The method was validated in terms of specificity, linearity, precision, accuracy, and robustness. This fully validated method, which allows the simultaneous measurement of amoxicillin and clavulanic acid in different formulations, is rapid (total run time <7 min). This assay is suitable for routine quality control of drugs