A validated RP-HPLC assay method for the estimation of Vilazodone hydrochloride in bulk and commercial tablet dosage form
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2017, Vol 5, Issue 4
Abstract
A simple, rapid, accurate, precise and sensitive reverse phase HPLC method was developed and validated for the estimation of Vilazodone Hydrochloride (VLH) in bulk and Pharmaceutical dosage form. The chromatographic separation was achieved by isocratic mode of elution using Hyperclone TMC18 (250x4.6 mm, particle size 5µm) column and mobile phase consisting of Methanol (HPLC Grade) and 0.1% Ortho Phosphoric Acid (OPA) in the ratio of 70: 30 % v/v was used with a flow rate of 1.0 ml/min and UV detection at 240 nm. The retention time was found to be 3.030 min for Vilazodone Hydrochloride (VLH). The developed method was validated as per ICH Q1A guidelines. The calibration curve of Vilazodone Hydrochloride (VLH) was found to be linear over the concentration range of 2.0 - 16 µg/ml with correlation coefficient value of 0.9998. The limit of detection (LOD) and limit of quantification (LOQ) values were found to be 0.49µg/ml and 1.49 µg/ml respectively. The mean % recoveries of Vilazodone Hydrochloride (VLH) in tablet dosage form were found to be 99.36% to 100.09%. The proposed method can be utilized in routine quality control analysis for quantitative determination of Vilazodone Hydrochloride (VLH) in bulk and tablet dosage form.
Authors and Affiliations
G. Rudrama Devi, MV Sai Krishna, P Dinseh Kumar, G. Saravanan, Mohammad Yunoos
Keywords
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- EP ID EP33465
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