Development and Validation of a Stability Indicating Assay Method for the Determination of Sultiam in Tablet Dosage Form by RP-HPLC

A. Srikanth^*, S. Mohammed Yusuf^2
*Assistant Professor, Department of Pharmaceutical Analysis, Vasavi Institute of Pharmaceutical Sciences, Kadapa.
²Assistant Professor, Department of Pharmacy, College of Health Sciences, Debre Tabor University, Ethiopia.

A  B  S  T  R A C T
A new method was developed for Stability Indicating Assay Method for the Determination of Sultiam in Tablet Dosage by using RP-HPLC method. The optimized chromatographic conditions were Hypersil ODS250X4.6mm, 5µ column, flow rate was 1ml/min, and mobile phase ratio was water: methanol 70:30 v/v and the detection wavelength was 245 nm. The retention time was found to be 5.943. The % purity of sultiam was found to be 98.8 (100%). The system suitability parameter for sultiam such as theoretical plates and tailing factor were found to be 7211 and 1.33 respectively. The correlation coefficient (R²) for Sultiam peak was found to be 1.000. The analytical method was validated according to ICH, Q2(R1). Hence the suggested RP-HPLC method can be used for routine analysis of sultiam in API and tablet dosage form.
Keywords: sultiam, RP-HPLC.