QUANTITATIVE NUCLEAR MAGNETIC RESONANCE SPECTROSCOPIC METHOD DEVELOPMENT AND VALIDATION OF SUMATRIPTAN SUCCINATE IN PHARMACEUTICAL TABLET DOSAGE FORM

Abstract

A new, simple and accurate quantitative proton nuclear magnetic resonance(qNMR) spectroscopic  method was developed to determine the sumatriptan succinate in pharmaceutical tablet formulation. In this developed quantitative nuclear magnetic resonance spectroscopy method,Maleic acid was used as internal standard(IS) due to there was no overlapping of the peak  to analyte peaks and deuterium oxide(D2O) was used as diluent. For the quantification of the sumatriptan succinate 4.43 ppm and 6.20 ppm  peaks were used as quantitative monitoring purpose to correspong to analyte sumatriptane succinate and Maleic acid internal standard(IS) respectively. The final optimized  method was validated as per International Conference on Hormonisation (ICH) guidelines in terms  of Specificity, Limit of detection (LOD), Limit of Quantitation (LOQ), Pecision, Linearity, Accuracy ,Solution stability and Robustness. This method could be used to determination of sumatriptane succinate  in bulk and  pharmaceutical  tablet dosage forms.