TY - JOUR AU - Athavia, Birva A. AU - Dedania, Zarna R. AU - Dedania, Ronak R. AU - Swamy, S. M. Vijayendra AU - Prajapati, Chetana B. PY - 2017/07/14 Y2 - 2024/03/28 TI - STABILITY INDICATING HPLC METHOD FOR DETERMINATION OF VILAZODONE HYDROCHLORIDE JF - International Journal of Current Pharmaceutical Research JA - Int J Curr Pharm Sci VL - 9 IS - 4 SE - Original Article(s) DO - 10.22159/ijcpr.2017v9i4.20975 UR - https://journals.innovareacademics.in/index.php/ijcpr/article/view/20975 SP - 123-129 AB - <p><strong>Objective: </strong>The aim and objective of this study was to develop and validate Stability Indicating HPLC method for determination of Vilazodone Hydrochloride.</p><p><strong>Methods: </strong>The method was carried out on a Phenomenex, C<sub>18</sub> (250x4.6 mm, 5 µm) Column using a mixture of Acetonitrile: Water (50:50v/v), pH adjusted to 3.3 with Glacial Acetic Acid for separation. The flow rate was adjusted at 1 ml/min and Detection was carried out at 240 nm.</p><p><strong>Results: </strong>The retention time of vilazodone hydrochloride was found to be 2.3 min. The calibration curve was found to be linear in the range 25-75µg/ml with a correlation coefficient (R<sup>2</sup>=0.996). The limit of detection and limit of quantitation were found to be 4.78µg/ml and 14.48µg/ml respectively. The % recovery of vilazodone hydrochloride was found to be in the range of 98.21±0.08 % to 99.07±0.64%. The proposed method was successfully applied for the estimation of vilazodone hydrochloride in marketed tablet formulation.</p><p>Vilazodone Hydrochloride was subjected to forced degradation under Acidic, Alkaline, Oxidation, Dry Heat and Photolytic degradation conditions. Vilazodone hydrochloride showed 3.12% degradation under acidic condition, 4.78% under alkaline condition, 7.8% under oxidation condition, 3.53% under dry heat condition and 4.9% under photolytic condition.</p><p>Acid degradation impurity was identified and characterised by LC-MS/MS was found to be 1-(4-Penten-1-yl) piperazine having molecular weight 154.253 (m/z 155.08) and Molecular Formula C<sub>9</sub>H<sub>18</sub>N<sub>2.</sub></p><strong>Conclusion: </strong>A simple, precise, rapid and accurate Stability Indicating HPLC method has been developed and validated for the determination of Vilazodone Hydrochloride in presence of its degradation products as per the ICH Guidelines.<p> </p> ER -