Analytical Method Development and Validation of Vortioxetine Hydrobromide by RP-HPLC on Bulk and Tablet Dosage Form

Rishikesh S. Bachhav; Avinash Gajanan Tapkire

Title:
Analytical Method Development and Validation of Vortioxetine Hydrobromide by RP-HPLC on Bulk and Tablet Dosage Form

Authors:
Avinash Gajanan Tapkire | Rishikesh S. Bachhav

Cite This Article :

Avinash Gajanan Tapkire | Rishikesh S. Bachhav "Analytical Method Development and Validation of Vortioxetine Hydrobromide by RP-HPLC on Bulk and Tablet Dosage Form" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-2, February 2022, pp.1171-1176, URL: https://www.ijtsrd.com/papers/ijtsrd49368.pdf

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Abstract :
Purpose: A simple, rapid, highly sensitive, selective, specific, robust RP-HPLC method has been developed and validated for the estimation of Vortioxetine HBr in bulk and Tablet Dosage form. Methods: The Chromatographic separation was obtained using a mobile phase ACN: Methanol: Water (40:50:10V/V) on column Cosmosil C18 (250mm x 4.6ID, Particle size: 5 micron) at 30? with UV detection 370 nm at flow rate 0.8 ml/min. The linearity was found to be 10-50µg/ml. The retention time was found to be 4.498 min. Results: The method was validated according to ICH. The correlation coefficient (r2) of HPLC method was found to be 0.9991. The LOD and LOQ were found to be 0.23927µg/ml and 0.72507 µg/ml respectively. The intra-day and inter-day precision and accuracy values for method were found to be = 2% RSD. Conclusion: The Proposed RP-HPLC method has been successfully applied to the commercial tablets without any interference of excipients. The method can be used for the routine analysis in industry for Vortioxetine HBr in bulk and tablet dosage forms.

Keywords :
Vortioxetine HBr, RP-HPLC, Tablet Dosage form, Mobile Phase, ICH, Validation, Depression

Publication Details:

Unique Identification Number : IJTSRD49368

Published In : Volume-6 | Issue-2, February 2022

Page Number(s) : 1171-1176

Publisher Name : IJTSRD | www.ijtsrd.com | E-ISSN 2456-6470

Copyright © 2019 by author(s) and International Journal of Trend in Scientific Research and Development Journal. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0) (http://creativecommons.org/licenses/by/4.0)

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