Development and validation of UV-spectrophotometric methods for the determination of sumatriptan succinate in bulk and pharmaceutical dosage form and its degradation behavior under varied stress conditions

摘要

The aim of the present work is to develop sensitive, simple, accurate, precise and cost effective UV-spectrophotometric methods for the determination of sumatriptan succinate (STS), an anti-migraine drug, in bulk and pharmaceutical dosage form; and also to monitor the degradation behavior of the drug under different ICH prescribed stress conditions. Two methods were developed using different solvents, 0.1 M HCl (method A) and acetonitrile (method B). The calibration graphs are linear over the range of 0.2–6.0 lg ml�1 in both the methods with a correlation coefficient (r) of 0.9999. The apparent molar absorptivity values are 7.59 · 104 and 7.81 · 104 l mol�1 cm�1, for method A and method B, respectively. The other optical characteristics such as Sandell’s sensitivity, limit of detection (LOD) and limit of quantification (LOQ) values are also reported. The accuracy and precision of the methods were evaluated based on intra-day and inter-day variations. The accuracy of the methods was further confirmed by standard addition procedure. The degradation behavior of the drug was studied by subjecting STS to an acid and alkaline hydrolysis, oxidative, thermal and UV degradation. This study indicated that STS was degraded in alkaline medium and in oxidative condition. The proposed methods were successfully applied to the determination of STS in tablets and the results obtained are comparable with the official method