A validated sensitive liquid chromatographic method for the estimation of Sumatriptan succinate in bulk drug and tablet dosage form

Aim: The present study was undertaken to develop a validated, sensitive, rapid, simple and economic an isocratic HPLC method for estimating Sumatriptan succinate in tablet dosage form. Materials and Methods: Normal phase chromatographic analysis was performed on an Ascentis® Si HPLC Column (25cmΧ2.1mm, 5μm) with ammonium phosphate − acetonitrile (80:20, v/v, pH 3.5 adjusted with ortho-phosphoric acid) at a flow rate of 1 ml/min and detection wavelength of 230 nm. System suitability tests essential for the assurance of quality performance of the method were performed. The method was validated for accuracy, precision, reproducibility, specificity, and robustness, limit of detection (LOD), and limit of quantification (LOQ), as per International Conference on Harmonization (ICH) guidelines. Results: A single sharp peak was obtained for Sumatriptan succinate at retention time of 6.8±0.01 min. The polynomial regression data for the calibration plots exhibited good linear relationship (r=0.9999) over a concentration range of 50-1050 ng/ml and the linear regression equation was y=120.9x+33.56. Accuracy ranged from 99.96% to 101.49%. The LOD and LOQ values were 11 and 35 ng/ml, respectively. Conclusion: The proposed method gave good resolution of Sumatriptan succinate. System suitability tests and statistical analysis performed prove that the method is precise, accurate and reproducible, and hence can be employed for routine analysis of Sumatriptan succinate in bulk and commercial formulations