Agomelatine is a new melatonergic antidepressant with a unique pharmacological action. A UV spectroscopy and stability-indicating RP-HPLC method was developed and validated for the determination of agomelatine in active pharmaceutical ingredient and tablet dosage form. In UV spectroscopic method methanol was used as solvent and λmax was found at 230 nm. Beer’s law was observed in the concentration range of 0.5-3 μg/ml (R2 = 0.997). LOD and LOQ were 0.04798 and 0.145395 μg/ml respectively. The method was validated for several parameters like accuracy, precision. The values of % RSD and % recovery were found to be satisfactory. RP-HPLC method was developed using thermo BDS hypersil C18 column (250 × 4.6 mm, 5μm) in isocratic mode. The mobile phase consisted of acetonitrile: 15 mM phosphate buffer pH 5 (40:60 v/v) with a flow rate of 1.0 ml/min (UV detection- 230nm). The retention time was found to be 6.9 min. Linearity was observed over the concentration range of 5-30 μg/ml (R2 = 0.996). The method is accurate and recovery was found to be in the range of 99.89-100.19%. The limit of detection of agomelatine was found to be 0.1218 μg/ml and limit of quantitation was found to be 0.3691 μg/ml. Agomelatine was subjected to stress conditions including acidic, alkaline, neutral, oxidation and thermal degradation. Agomelatine is more sensitive to acidic, basic and oxidative degradation. These methods were validated according to ICH guidelines.
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