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340524

Development and Validation of RP-HPLC Method for Analysis of Counterfeit Clopidogrel

Article

Last updated: 24 Dec 2024

Subjects

-

Tags

Other aspects of medical and pharmaceutical sciences.

Abstract

Isocratic RP-HPLC method was developed and validated for the analysis of clopidogrel bisulfate counterfeited with acetyl salicylic acid and applied for the determination of clopidogrel bisulfate in pharmaceutical dosage forms. Clopidogrel bisulfate is commonly counterfeited with acetyl salicylic acid and it is not labeled to contain acetyl salicylic acid due to their similar pharmacological effect in inhibiting platelet aggregation. The mobile phase was composed of potassium dihydrogen phosphate buffer 0.02M (pH 2.8) and methanol 30:70 (v/v). The flow rate was 1.5mL/min. Diode array detector was set at 220 nm. The linearity ranges were 10-70 µg/mL and 6-50 µg/mL for clopidogrel bisulfate and acetyl salicylic acid, respectively. The retention time was 2.5 min and 10.23 min for clopidogrel bisulfate and acetyl salicylic acid, respectively. The method was validated according to ICH guidelines. The developed method was successfully applied for the determination of clopidogrel bisulfate counterfeited with acetyl salicylic acid as well as estimation of clopidogrel bisulfate in its different dosage forms.

DOI

10.21608/jampr.2024.255346.1061

Keywords

Isocratic HPLC, clopidogrel bisulfate, dosage forms, Acetyl salicylic acid

Authors

First Name

Badiea

Last Name

Soliman

MiddleName

-

Affiliation

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Tanta University, Tanta, Egypt.

Email

badieasoliman@gmail.com

City

-

Orcid

0009-0008-2305-5377

First Name

Mokhtar

Last Name

Mohamed Mabrouk

MiddleName

-

Affiliation

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Tanta University

Email

mokhtar.mabrouk@pharm.tanta.edu.eg

City

-

Orcid

0000-0003-4181-7749

First Name

Sherin

Last Name

Hammad

MiddleName

-

Affiliation

Department of pharmaceutical analytical Chemistry, Faculty of Pharmacy, Tanta University, Tanta, Egypt

Email

sherinhammad@yahoo.com

City

-

Orcid

0000-0003-2102-1081

First Name

Amira

Last Name

Kamal

MiddleName

H.

Affiliation

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Tanta University, Tanta, Egypt.

Email

mrmrkamal33@yahoo.com

City

-

Orcid

0000-0003-4716-5139

Volume

5

Article Issue

1

Related Issue

46784

Issue Date

2024-03-01

Receive Date

2023-12-13

Publish Date

2024-03-01

Page Start

34

Page End

41

Online ISSN

2636-4158

Link

https://jampr.journals.ekb.eg/article_340524.html

Detail API

https://jampr.journals.ekb.eg/service?article_code=340524

Order

340,524

Type

Original Article

Type Code

855

Publication Type

Journal

Publication Title

Journal of Advanced Medical and Pharmaceutical Research

Publication Link

https://jampr.journals.ekb.eg/

MainTitle

Development and Validation of RP-HPLC Method for Analysis of Counterfeit Clopidogrel

Details

Type

Article

Created At

24 Dec 2024