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300772

STUDY OF RELATED IMPURITIES PROFILE BY HPLC: CASE OF FIVE SAMPLES OF FLUCONAZOLE ACTIVE PHARMACEUTICAL INGREDIENT

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Last updated: 04 Jan 2025

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Abstract

The main objective of this work was to analysis nine drug related impurities (A-I) by High Performance Liquid Chromatography (HPLC) in five samples (F1-F5) of Fluconazole active pharmaceutical ingredient (API), collected from five pharmaceutical industries installed in Algeria. For the organic related-impurities analysis, a liquid chromatography apparatus HPLC-UV device equipped with an automatic injector and UV/Vis detector and a column (C18), deactivated for the bases, post-grafted (5 μm) and dimensions (w: 0.15 m, Ø: 4.6 mm) were used. Each sample of Fluconazole API was processed according to the related substances procedures of the European Pharmacopoeia (EP), 8th edition. The HPLC related-impurities analysis showed that the F1, F3, F4 and F5 samples had an individual content of specified impurities (A, B and C) and unspecified impurities meeting the required standards with a total of all impurities present meeting with the standard. F2 sample had a high content of unspecified impurity 0.126 % compared to the acceptance limit and a total of impurities 0.387 % meeting the standard. This can be explained either by the sample degradation which may be due to poor storage conditions or the batch from which this sample comes wasn't well purified during the synthesis route

DOI

10.21608/bfsa.2023.300772

Keywords

drug related impurities, related substances, unspecified impurities, specified impurities HPLC-UV, Fluconazole

Authors

First Name

Derouicha

Last Name

Matmour

MiddleName

-

Affiliation

Therapeutic and Pharmaceutical Chemistry Laboratory, Pharmacy Department, Faculty of Medecine, University of Sidi Bel-Abbes, 22000, Algeria / Central Laboratory, University Hospital Center of Sidi Bel-Abbes, 22000, Algeria

Email

drmatmour24@hotmail.fr

City

-

Orcid

-

First Name

Nadjib

Last Name

Hamoum

MiddleName

-

Affiliation

Quality Control Laboratory, WanyLab, 16002 Algiers, Algeria

Email

nadjib.hamoum@gmail.com

City

-

Orcid

-

First Name

Khalil

Last Name

Hassam

MiddleName

Fateh Eddine

Affiliation

Quality Control Laboratory, WanyLab, 16002 Algiers, Algeria

Email

-

City

-

Orcid

-

First Name

Amel

Last Name

CHENAFA

MiddleName

-

Affiliation

Central Laboratory, University Hospital Center of Sidi Bel-Abbes, 22000, Algeria

Email

amel.ph2007@yahoo.fr

City

-

Orcid

-

First Name

Khadidja

Last Name

Yanallah

MiddleName

-

Affiliation

Galenic Pharmacy laboratory, University of Oran, 31000, Algeria

Email

yan-khad@hotmail.com

City

-

Orcid

-

First Name

Yassine

Last Name

Merad

MiddleName

-

Affiliation

Central Laboratory, University Hospital Center of Sidi Bel-Abbes, 22000, Algeria

Email

merad9@yahoo.fr

City

-

Orcid

-

First Name

Nassima

Last Name

Ziani

MiddleName

Hamdi

Affiliation

Quality Control Laboratory, WanyLab, 16002 Algiers, Algeria

Email

-

City

-

Orcid

-

Volume

46

Article Issue

1

Related Issue

41495

Issue Date

2023-06-01

Receive Date

2022-09-14

Publish Date

2023-06-01

Page Start

129

Page End

140

Print ISSN

1110-0052

Online ISSN

3009-7703

Article File

BFSA_Volume 46_Issue 1_Pages 129-140.pdf

PDF . 1.0MB

Link

https://bpsa.journals.ekb.eg/article_300772.html

Detail API

https://bpsa.journals.ekb.eg/service?article_code=300772

Order

300,772

Type

Original Article

Type Code

1,096

Publication Type

Journal

Publication Title

Bulletin of Pharmaceutical Sciences Assiut University

Publication Link

https://bpsa.journals.ekb.eg/

MainTitle

STUDY OF RELATED IMPURITIES PROFILE BY HPLC: CASE OF FIVE SAMPLES OF FLUCONAZOLE ACTIVE PHARMACEUTICAL INGREDIENT

Details

Type

Article

Created At

25 Dec 2024