Abstract

DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF TOPIRAMATE BULK AND PHARMACEUTICAL DOSAGE FORM

Sivakameswari Somi Reddy*, Suresh Kannan.V, Nagaraju P.T., Dr.Venugopal. K, Murali Krishna. N.V, Ramadevi. R

Abstract

A simple, specific, accurate and precise Spectroscopy method was developed and validated for the estimation of Topiramate in pharmaceutical dosage forms. The Standard solution was prepared by weighing 100 mg of Topiramate in 100 ml volumetric flask with methanol. The final Standard solution was made to produce 1000 μg / ml with methanol. Further dilutions were prepared as per procedure and were scanned at 260 nm. The linearity was found in the concentration range of 1-6 μg / ml. The Correlation coefficient was 0.999. The regression equation was found to be Y = 0.482 X - 0.035. The method was validated for linearity, accuracy, precision, limit of detection, limit of quantitation and ruggedness robustness. The limit of detection and limit of quantitation for estimation of Topiramate was found to be 0.010 (μg / ml) and 0.032 (μg / ml), respectively. The percentage recovery of Topiramate was found to be in the range of 100.36 ± 0.081 - 100.81 ± 0.055. Proposed method can be successfully applied for the quantitative determination of Topiramate in pharmaceutical dosage forms.

Keywords: Topiramate; Method validation; UV-Spectroscopy; ICH guidelines..