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Abstract

STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF ZONISAMIDE IN PHARMACEUTICAL DOSAGE FORM

Hemant Shah*, Khushbu K. Patel, Pruthviraj Chaudhary and Dr. C. N. Patel

ABSTRACT

A simple, efficient and precise stability indicating RP-HPLC method developed and validated to measure Zonisamide at wavelength (238 nm) in order to assay. Zonisamide is used to treat angina pectoris (Parkinson’s disease, antiepileptic disease, tardive dyskinesia, obesity, migraine and mood stabilizer). Methanol was used as a solvent with λmax of drug was found to be 238 nm. The samples were eluted in a low pressure gradient method using a KROMASIL C18 (250mm×4.6mm, 5μm particle size) with a mobile phase consisting of ACN: methanol: water (30:45:25) using as diluents through ambient temperature delivered at a flow rate 1 ml/min. This sample was used for degradation studies. Linearity was observed in the range of 5-25 μg/mL with a regression coefficient of 0.9988. The stress degradation studies showed that Zonisamide undergoes degradation in acidic, alkali, neutral, oxidative, thermal and photolytic stress conditions. The method was validated as per ICH guideline.

Keywords: Zonisamide, Reversed phase, Forced degradation study, Validation


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