Article Subject
Pharmacy
Abstract

A simple, selective, linear, precise and accurate RP-HPLC method was developed and validated for
rapid assay of FIDAXOMICIN in tablet dosage form. Isocratic elution at a flow rate of 1ml min-1 was
employed on a symmetry C18 column at ambient temperature. The mobile phase consisted of
0.1%OPA,,Acetonitrile,water:mathanol 20:25:25:30 (v/v/v/v). The UV detection wavelength was at
224nm.Linearity was observed in concentration range of 25-70ppm. The retention time for
FIDAXOMICIN was 4.3 min. The method was validated as per the ICH guidelines. The proposed
method can be successfully applied for the estimation of FIDAXOMICIN in pharmaceutical dosage
forms

Keywords
Fidaxomicin
HPLC
Development
224nm.