Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF TOPIRAMATE BULK AND PHARMACEUTICAL DOSAGE FORM BY USING HPLC METHOD

Sivakameswari Somireddy*, Sureshkannan.V, Nagaraju P.T., Dr.Venugopal. K, Muralikrishna. N.V, Ramadevi.R

ABSTRACT

A simple, specific, accurate, and precise High Performance Liquid Chromatographic (HPLC) method was developed and validated for the estimation of Topiramate in pharmaceutical dosage forms. C-18, 5 μm column having 250 x 4.6 mm internal diameter in isocratic mode, with mobile phase containing Buffer: Acetonitrile (40: 60 v / v) was used. The flow rate was 1 ml / min and effluents were monitored at 260 nm. Chromatogram showed the main peak at a retention time of 4.51 min. The method was validated for linearity, accuracy, precision, and limit of detection, limit of quantitation, robustness, ruggedness, specificity and assay. The limit of detection and limit of quantitation for estimation of Topiramate was found to be 0.06 (μg / ml) and 0.018 (μg / ml). Recovery of Topiramate was found to be in the range of 99.76-101.303 %. Proposed method can be successfully applied for the quantitative determination of Topiramate in pharmaceutical dosage forms.

Keywords: Topiramate; Method validation; HPLC; ICH guidelines.