Beta
7263

STABILITY INDICATING HPLC METHOD FOR THE DETERMINATION OF AGOMELATINE INPLASMA AND TABLET FORMULATION

Article

Last updated: 03 Jan 2025

Subjects

-

Tags

-

Abstract

A stability indicating HPLC method was developed and validated for quantitative determination of agomelatine in plasma and tablet formulation in the presence of degradation products generated from forced degradation studies. An HPLC method was developed to separate the drug from the degradation products using Waters spherisorb Cyano C18 column (250 x4.6mm, 5μm) and a mobile phase constituted of trifluoroacetic acid buffer and methanol (50:50 % v/v). The wave length of the detection is 230 nm at a flow rate 1mL/min. The validation data showed that the assay is accurate, precise, sensitive, specific and reproducible for the determination of agomelatine in plasma as well as in tablet formulation in the presence of its degradants. The method is linear from 12.5-37.5 μgmL-1 and accuracy of the method was found to be 100.5 -100.9 % for tablets and 97.84 – 101.24% for plasma. The proposed method was found to be suitable for quantitative determination and the stability study of the drug in plasma and tablet formulation.

DOI

10.21608/ajps.2012.7263

Keywords

Agomelatine, stability indicating HPLC method, plasma and tablet formulation

Authors

First Name

Hamed

Last Name

Abuseada

MiddleName

-

Affiliation

Analytical Chemistry Department, Faculty of Pharmacy, Al-Azhar University, Cairo, Egypt

Email

-

City

-

Orcid

-

Volume

45

Article Issue

1

Related Issue

1362

Issue Date

2012-03-01

Receive Date

2018-05-15

Publish Date

2012-03-01

Page Start

535

Page End

548

Print ISSN

1110-1644

Online ISSN

2535-1958

Link

https://ajps.journals.ekb.eg/article_7263.html

Detail API

https://ajps.journals.ekb.eg/service?article_code=7263

Order

34

Type

Original Article

Type Code

518

Publication Type

Journal

Publication Title

Al-Azhar Journal of Pharmaceutical Sciences

Publication Link

https://ajps.journals.ekb.eg/

MainTitle

STABILITY INDICATING HPLC METHOD FOR THE DETERMINATION OF AGOMELATINE INPLASMA AND TABLET FORMULATION

Details

Type

Article

Created At

22 Jan 2023