CHEMICAL FORCE DEGRADATION ASSAY METHOD EVALUATION FOR SIMULTANEOUS ESTIMATION OF AMOXICILLIN AND POTASSIUM CLAVULANATE IN ORAL DOSAGE FORM

Sumaiya Fatima*, Dr. Osman Ahmed and Dr. Anas Rasheed

ABSTRACT

A specific, precise, accurate ultra pressure liquid chromatography (UPLC) method is developed for estimation of amoxicillin and potassium clavulanate in bulk dosage form. The method employed, with Xterra RP-8 (150mm x 4.6 mm i.d., particle size 5 μm) in a gradient mode, with mobile phase of KH2PO4: Methanol (80:20). The flow rate was 0.5 ml/min and effluent was monitored at 248 nm. During the stability analysis of the drug product, all known impurities were detected by the above stability-indicating method. No chromatographic interference from excipients and degradants were found. The proposed method was successfully used for estimation of amoxicillin and potassium clavulanate in bulk dosage form.

Keywords: amoxicillin, potassium clavulanate, oral dosage form, UPLC method.