DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF ZONISAMIDE FROM TABLET FORMULATION
Shivrani W. Nimbokar, Neha A. Badukale, Wrushali A. Panchale, Ravindra L. Bakal,
Bhushan R. Gudalwar, Jagdish V. Manwar*
ABSTRACT
A new RP-HPLC method was developed for the rapid estimation of zonisamide from tablet formulation. The separation was carried out on Inertsil C18 ODS (4.6mm I.D x 250 mm) using mobile phase methanol and water (50:50, v/v) with retention time 4.71 min at flow rate 1.0 ml/min. at 238 nm. The validation of proposed method was performed in terms of linearity and range, accuracy and precision, and robustness. The drug showed the linearity over the concentration range from 1-5 ?g/mL with r2 0.998. Limit of detection and limit of quantitation was found to be 0.413?g/mL and 0.005 ?g/mL, respectively. The average percentage recovery obtained for drug from tablet formulation was 99.17 to 101.04. In robustness, after slightly varying in chromatographic conditions, no significant change in response was recorded. Method was validated as per ICH guidelines.
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