HPLC METHOD FOR THE ESTIMATION OF ZONISAMIDE IN ITS FORMULATION

Abstract

Zonisamide (ZON) is an anti epileptic used for adjunctive therapy of partial seizures in adults, and children (6 years and above). Many methods for the estimation of Zonisamide have been reported which include spectrophotometry and HPLC methods. A validated HPLC method has been developed for estimation of Zonisamide in its formulation. In HPLC method, a C18 column and methanol: acetonitrile : water in the ratio 60:30:10, pH adjusted to 3.0 using orthophosphoric acid were used at a flow rate of 0.8 mL/min and detected at 285 nm. The retention time for Zonisamide was found to be 3.6 min. The developed method was validated for linearity, precision, accuracy, specificity, LOD and LOQ as per ICH guidelines. Linearity was observed in the range of 5-25 μg/mL for Zonisamide and correlation coefficient was found to be 0.9954. LOD and LOQ for Zonisamide were found to be 0.11 μg/mL and 0.33 μg/mL respectively. The % recovery was found to be 99.8%. The method was applied for estimation of Zonisamide in its pharmaceutical dosage form. The assay result was found to be 99.5% of percentage label claim of Zonisamide.