Development and validation of a stability indicating HPLC method for estimation of methimazole in bulk
Developed and validated the method for the determination of methimazole in bulk drug and marketed formulation. The method has been clearly defined, stability-indicating and reproducible. The optimized method constitutes of best separation by using the ODS-3V C18(250X 4.6 mm)5μm column. The mobile phase consists of water: acetonitrile (90:10 v/v) with 1% TFA for the good peak shape of the analyte, the range selected for the detector linearity from 30 ppm to 150 ppm. As per the ICH, guideline method has been performed on different parameters like specificity and accuracy. For stability study, the drug was wide open to stress conditions such as acid, base, heating, and peroxidase. The method was proved to be robust concerning changes in flow rate, temperature, and wavelength. The planned method is found to be rapid, precise, reproducible, sensitive and abundance column life.