361809

Development and Validation of Green Stability-Indicating RP-HPLC Method for Estimation of Ertapenem: Degradation Kinetics and Structural Mass Elucidation Using MS

Article

Last updated: 15 Feb 2025

Subjects

-

Tags

Analytical chemistry

Abstract

Ertapenem is an antibiotic that is used in the treatment of several bacterial infections, and it was recently approved for the treatment of the COVID-19 virus. A simple validated stability-indicating reversed phase High Performance Liquid Chromatographic (RP-HPLC) method was developed for ertapenem estimation. The separation was done using Pronto SIL® C18 (300 × 4.6 mm, 5 μm) as the stationary phase, methanol, and acidified water as the mobile phase in gradient mode with a flow rate of 1 mL/min and a pH 4.0 adjusted by orthophosphoric acid. The method was validated according to ICH guidelines. The linearity ranges from 5.00-120.00 µg/mL with LOD 1.60 µg/mL and LOQ 4.85 µg/mL. Afterwards, the degradation behaviour of ertapenem was studied under various stress conditions, including acidic, basic, oxidative, thermal, and photolytic. The degradation study showed stability of ertapenem under thermal, photolytic degradation and severe degradation under acid, basic and oxidative conditions. The kinetics parameters were studied for acidic and basic degradation. The parameters showed that it follows a pseudo-first order reaction. Degradation products were structurally elucidated using mass spectrometry. The method has been evaluated as an excellent green analytical method based on eco-scale penalty points and the analytical greenness metric approach.

DOI

10.21608/ejchem.2024.270470.9378

Keywords

ertapenem, Forced degradation, HPLC, degradation kinetics, Mass Spectrometry, COVID-19

Authors

First Name

Sohair

Last Name

aboelghar

MiddleName

mohamed

Affiliation

Pharmaceutical Chemistry Department, Faculty of Pharmacy, The British University in Egypt, El-Sherouk City, P.O. Box 43, Cairo, 11837, Egypt.

Email

sohair.aboelghar@bue.edu.eg

City

-

Orcid

-

First Name

Maha

Last Name

Hegazy

MiddleName

abdelmonem

Affiliation

Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr-El-Aini Street, Cairo11562, Egypt.

Email

maha.hegazy@pharma.cu.edu.eg

City

Cairo

Orcid

0000-0002-7486-1423

First Name

Hebatallah

Last Name

Wagdy

MiddleName

A

Affiliation

Pharmaceutical Chemistry Department, Faculty of Pharmacy, The British university in Egypt (BUE)

Email

hebatallah.wagdy@bue.edu.eg

City

Cairo

Orcid

0000-0003-1975-7700

Volume

68

Article Issue

2

Related Issue

53637

Issue Date

2025-02-01

Receive Date

2024-02-22

Publish Date

2025-02-01

Page Start

385

Page End

399

Print ISSN

0449-2285

Online ISSN

2357-0245

Link

https://ejchem.journals.ekb.eg/article_361809.html

Detail API

http://journals.ekb.eg?_action=service&article_code=361809

Order

361,809

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 Green Stability-Indicating RP-HPLC Method for Estimation of Ertapenem: Degradation Kinetics and Structural Mass Elucidation Using MS

Details

Type

Article

Created At

15 Feb 2025