STABILITY INDICATING HPLC METHOD FOR DETERMINATION OF VILAZODONE HYDROCHLORIDE


Birva A. Athavia, Zarna R. Dedania, Ronak R. Dedania, S. M. Vijayendra Swamy, Chetana B. Prajapati

Abstract


Objective: The aim and objective of this study was to develop and validate Stability Indicating HPLC method for determination of Vilazodone Hydrochloride.

Methods: The method was carried out on a Phenomenex, C18 (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.

Results: 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 (R2=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.

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.

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 C9H18N2.

Conclusion: 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.

 


Keywords


Vilazodone Hydrochloride, HPLC, Stability Indicating Method, Acid Degradation Impurity

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About this article

Title

STABILITY INDICATING HPLC METHOD FOR DETERMINATION OF VILAZODONE HYDROCHLORIDE

Keywords

Vilazodone Hydrochloride, HPLC, Stability Indicating Method, Acid Degradation Impurity

DOI

10.22159/ijcpr.2017v9i4.20975

Date

14-07-2017

Additional Links

Manuscript Submission

Journal

International Journal of Current Pharmaceutical Research
Vol 9, Issue 4, 2017 Page: 123-129

Online ISSN

0975-7066

Statistics

31 Views | 2 Downloads

Authors & Affiliations

Birva A. Athavia
Bhagwan Mahavir College of Pharmacy (215), BMEF Campus, Bharthana, Vesu, Surat 395017

Zarna R. Dedania
Bhagwan Mahavir College of Pharmacy (215), BMEF Campus, Bharthana, Vesu, Surat 395017

Ronak R. Dedania
Bhagwan Mahavir College of Pharmacy (215), BMEF Campus, Bharthana, Vesu, Surat 395017

S. M. Vijayendra Swamy
Bhagwan Mahavir College of Pharmacy (215), BMEF Campus, Bharthana, Vesu, Surat 395017

Chetana B. Prajapati
Bhagwan Mahavir College of Pharmacy (215), BMEF Campus, Bharthana, Vesu, Surat 395017


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