Abstract

SIMULTANEOUS DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR DETERMINATION OF ZONISAMIDE AND CILOSTAZOL IN SYNTHETIC MIXTURE

Sapna Nishad R.* and Dr. Zarna R. Dedania

Abstract

A simple, precise, specific and accurate HPTLC method as per ICH guidelines has been developed and validated for estimation of Zonisamide and Cilostazol in synthetic mixture.The separation was carried out on HPTLC Aluminium plates pre-coated with silica-gel 60 F254 (10 ×10 cm) using Ethyl acetate: chloroform (6:4 v/v) as mobile phase. HPTLC separation of the two drugs followed by chromatographic measurement was carried out in the absorbance mode at 254nm. The drugs were resolved satisfactorily with Rf values of 0.76 ± 0.2 and 0.46 ± 0.2 for Zonisamide and Cilostazol respectively. The linear regression analysis data for the calibration plots showed good linear relationship with R2=0.999 and 0.999 for Zonisamide and Cilostazol respectively in the concentration range of 100-600 ng/spot for Zonisamide and 100-600 ng/spot for Cilostazol. The method was validated for accuracy, precision, specificity and robustness. The percentage recoveries of Zonisamide and Cilostazol were found to be 98.5-100.12% and 99.2-100.11% respectively. The developed methods were validated statistically. The suitability of methods for quantitative determination of these compounds is proved by validation in accordance with the requirements of ICH Guidelines.

Keywords: Zonisamide, Cilostazol, HPTLC method, Validation.