213715

Development and Validation of Stability-Indicating GC-MS Method for Simultaneous Determination of Lumefantrine and Artemether

Article

Last updated: 01 Jan 2025

Subjects

-

Tags

Analytical chemistry

Abstract

A sensitive, accurate and precise stability-indicating gas chromatography mass spectrometry (GC-MS) method was developed for simultaneous determination of lumefantrine and artemether in pure form and pharmaceutical formulation.In this study, comprehensive stress testing of lumefantrine and artemether have been carried out according to ICH guidelines Q1A (R2). Lumefantrine and artemether were subjected to forced degradation studies under hydrolytic (acid and base), oxidative, photolysis, and thermal stress conditions. The chromatographic separation was performed usinga ZB5 column with (30 m ×0.53 mm, 1.50 µm), and helium as a carrier gas. The proposed method showed well separation between the drugs and their degradation products and had a good accuracy. The method was linear with 12-120 ng mL-1 and 4-40 ng mL-1 for lumefantrine and artemether respectively. The method showed to be linear (r2 > 0.999), precise (RSD

DOI

10.21608/ejchem.2022.105371.4856

Keywords

Lumefantrine, artemether, Stability indicating method, pharmaceutical formulation

Authors

First Name

Mohamed

Last Name

Nassar

MiddleName

-

Affiliation

Al-azhar university - EGYPT

Email

mw-nassar@yahoo.com

City

-

Orcid

-

First Name

Ahmed

Last Name

El-Olemy

MiddleName

-

Affiliation

Al-azhar university - Egypt

Email

ahmed-olemy2000@azhar.edu.eg

City

-

Orcid

-

First Name

Mohamed

Last Name

Emara

MiddleName

-

Affiliation

Al-azhar university - Egypt

Email

mohamed.emara83@yahoo.com

City

-

Orcid

-

First Name

Ahmed

Last Name

Mohamed

MiddleName

-

Affiliation

Ministry of Healtth

Email

ahmedabdrabou31@yahoo.com

City

-

Orcid

12345678912345

Volume

65

Article Issue

10

Related Issue

34864

Issue Date

2022-10-01

Receive Date

2021-11-10

Publish Date

2022-10-01

Page Start

101

Page End

106

Print ISSN

0449-2285

Online ISSN

2357-0245

Link

https://ejchem.journals.ekb.eg/article_213715.html

Detail API

https://ejchem.journals.ekb.eg/service?article_code=213715

Order

9

Type

Original Article

Type Code

297

Publication Type

Journal

Publication Title

Egyptian Journal of Chemistry

Publication Link

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

MainTitle

Development and Validation of Stability-Indicating GC-MS Method for Simultaneous Determination of Lumefantrine and Artemether

Details

Type

Article

Created At

22 Jan 2023