119986

Validated HPLC and HPTLC Methods for the Determination of Agomelatine in Bulk and Tablets

Article

Last updated: 01 Jan 2025

Subjects

-

Tags

Analytical chemistry

Abstract

The present study represents validated simple, rapid and reliable chromatographic methods for analysis of the antidepressant drug agomelatine (AGO) in bulk powder and in tablet dosage form. Method I involved application of RP-HPLC with diode array detection where Agilent Zorbax Eclipse-C18 column (4.6 × 150 mm, 5 μm) was used as stationary phase at ambient temperature (25±5). The mobile phase was composed of phosphate buffer (0.05 M, pH 3) and acetonitrile in the ratio 60:40 (v/v) and was pumped isocratically at 1 mL/min. In method II, HPTLC plates (20 × 10 cm, aluminum plates with 250-μm thickness precoated with silica gel 60 F254) was used as stationary phase with mobile phase composed of chloroform: methanol (9.3: 0.7, v/v). Detection was carried out at 230 nm in both methods. The structurally related melatonin was used as internal standard (IS) in both methods. The developed methods were validated according to International Conference of Harmonization (ICH) guidelines with respect to linearity, ranges, accuracy, precision, robustness and limits of detection and quantitation. Linearity ranges were 0.5-3 μg/mL and 25-200 ng/spot in method I and method II respectively. Limits of detection and quantitation were 0.081 and 0.25 μg/mL for method I and 4.65 and 14.11 ng/spot for method II, respectively. Intra and inter-day precision were verified by the RSD% values which were less than 2%. The methods were implemented for assay of AGO tablet dosage form with no observable interferences.

DOI

10.21608/ejchem.2020.42028.2845

Keywords

HPLC, HPTLC, Agomelatine, bulk, Tablets, validation

Authors

First Name

Hala

Last Name

Labib

MiddleName

-

Affiliation

Department of Pharmaceutical Chemistry, College of Pharmacy, Arab Academy for Science, Technology and Maritime Transport, Alexandria, Egypt

Email

hflabib@gmail.com

City

-

Orcid

-

First Name

Hytham

Last Name

Ahmed

MiddleName

-

Affiliation

Menoufia University

Email

hmaahmed@yahoo.co.uk

City

-

Orcid

-

First Name

Yousef

Last Name

Elshamy

MiddleName

-

Affiliation

Pharmaceutical Chemistry Department, Faculty of Pharmacy and Drug Manufacturing, Pharos University in Alexandria, Alexandria, Egypt

Email

dr.joealshamy@yahoo.com

City

-

Orcid

-

First Name

Wael

Last Name

Talaat

MiddleName

-

Affiliation

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Damanhour University, Damanhour 25511, Egypt

Email

wtalaat2017@gmail.com

City

-

Orcid

-

First Name

Tarek

Last Name

Belal

MiddleName

-

Affiliation

Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, University of Alexandria, Alexandria, Egypt

Email

tbelaleg@yahoo.com

City

-

Orcid

0000-0002-1138-595X

Volume

64

Article Issue

2

Related Issue

21013

Issue Date

2021-02-01

Receive Date

2020-09-06

Publish Date

2021-02-01

Page Start

957

Page End

969

Print ISSN

0449-2285

Online ISSN

2357-0245

Link

https://ejchem.journals.ekb.eg/article_119986.html

Detail API

https://ejchem.journals.ekb.eg/service?article_code=119986

Order

37

Type

Original Article

Type Code

297

Publication Type

Journal

Publication Title

Egyptian Journal of Chemistry

Publication Link

https://ejchem.journals.ekb.eg/

MainTitle

Validated HPLC and HPTLC Methods for the Determination of Agomelatine in Bulk and Tablets

Details

Type

Article

Created At

22 Jan 2023