Development and Validation of Stability Indicating HPTLC Method for Estimation of Vilazodone Hydrochloride

Author(s)

Damle, M.C., Agrawal, A.A.

Author's Affiliation

Abstract

A simple and sensitive stability indicating HPTLC method has been developed and validated for estimation of Vilazodone hydrochloride. Separation of the drug was carried on aluminium plates precoated with silica gel 60 F₂₅₄ using Toluene: Methanol (7:3 v/v) as mobile phase. The retention factor (R_f) for Vilazodone hydrochloride was found to be 0.50 ± 0.04. The detection was carried at 240 nm. Stress testing of Vilazodone hydrochloride was carried out according to the International conference of harmonization (ICH) guideline Q1A (R2). The drug was subjected to acid, base, neutral hydrolysis, oxidation, thermal degradation and photolysis. The method was successfully validated according to ICH guidelines Q2 (R1). The data of linear regression analysis indicated a good linear relationship over the range of 100–500 ng/band concentrations with correlation coefficient 0.995. The accuracy of the method was established based on the recovery studies. The LOD and LOQ were 2.21 and 6.75 ng/band respectively. Vilazodone hydrochloride showed considerable degradation under alkaline, acidic, oxidative and neutral hydrolytic condition.

Keywords

Vilazodone Hydrochloride, High Performance Thin Layer Chromatography (HPTLC), Validation, Stability-Indicating Method

Cite This Article

Damle, M.C., Agrawal, A.A. (2015). Development and Validation of Stability Indicating HPTLC Method for Estimation of Vilazodone Hydrochloride, International Journal for Pharmaceutical Research Scholars (IJPRS), 4(1), 262-268.