Stability indicating RP-HPLC method development and validation for the estimation of sumatriptan in bulk and pharmaceutical dosage form

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Abstract

A simple, highly sensitive stability indicating reverse phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the determination of sumatriptan succinate in bulk and tablet dosage form. The analysis was performed on reverse phase C18 ODS Inertsil (250×4.6mm, 5μm) column, with a mobile phase containing buffer: aetonitrile: methanol (80:10:10 v/v/v), pH was adjusted to 2.5 with orthophosphoric acid (OPA) at 221nm, by an isocratic elution mode with 1ml/min flow rate using photo diode array (PDA) detector at ambient temperature. The injection volume and retention time was found 20 μl and 4.4 minutes respectively. The method produced linear responses in the concentration range of 5-150 μg/ml, with a correlation coefficient of 0.999. The limit of detection (LOD) and limit of quantification (LOQ) values for HPLC method were found to be 1.967 and 5.961 μg/ml respectively. The recovery of the method was 98% of the labelled value. This method was validated for accuracy, precision, linearity and robustness. Sumatriptan subjected to different ICH prescribed stress conditions of acid, alkali, peroxide, reduction, thermal, photolytic and humidity degradation. This method can easily and conveniently take up for routine quantitative analysis of sumatriptan in bulk and pharmaceutical dosage form by easily available materials with low cost.

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Srinidhi, M., Basha, M. M., Raj Kumar, V., & Rajendra Kumar, J. (2016). Stability indicating RP-HPLC method development and validation for the estimation of sumatriptan in bulk and pharmaceutical dosage form. Journal of Applied Pharmaceutical Science, 6(6), 20–25. https://doi.org/10.7324/JAPS.2016.60604

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