Development of a validated spectrofluorimetric method for assay of sotalol hydrochloride in tablets and human plasma: Application for stability-indicating studies

Abstract

The native fluorescence of sotalol hydrochloride (SOT) was used as a basis for establishing a new method of analysis for SOT in tablets and spiked human plasma. The fluorescence of SOT in water was measured at 310 nm when excited at 235 nm. The detection limit (LOD) was 0.37 ng/mL and the quantification limit (LOQ) was 1.08 ng/mL. The proposed method offers high sensitivity which permits determination of SOT, even if present in a very small amount, in human plasma. The obtained results were successfully compared to that of a reference pharmacopeial method and statistical analysis proved a good agreement between the results of both methods. Further investigation of the SOT stability upon exposure to various stress conditions, such as acidic, alkaline, oxidative and photolytic degradation conditions was also performed. The kinetics of acidic, alkaline and oxidative degradation of the drug showed a pseudo first order degradation reaction. A proposal of the degradation pathway was suggested and confirmed by developing a thin layer chromatographic method used for separation of SOT and its acidic and alkaline degradation products.