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300769

RESIDUAL SOLVENTS ANALYSIS IN METRONIDAZOLE RAW MATERIAL USING HEAD SPACE GAS CHROMATOGRAPHY

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Last updated: 25 Dec 2024

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Abstract

In pharmaceutical raw material (PRM), the residual solvents (RS) are residual impurities                   which must be controlled due to their toxicity. In this study, we report the quality control results of residual solvents impurties analysis using head space gas chromatography with flame ionization detector (HS-GC-FID) of six raw materials samples of Metronidazole marketed in Algeria. The GC is equipped with a flame-ionization detector and silica column coated with 1.8 µm layer of phase G43. The carrier gas is nitrogen with a linear velocity of 35 cm/s and a split ratio of 1:5. The column temperature is 40 °C then it rise to 240 °C. The injection temperature is 140 °C and that of detector is 250 °C. 29 organic solvents belongs to classes 1 and 2 were researched whose control is mandatory because of their carcinogenic and intrinsic toxicity, only five solvents were identified in the different samples and the methanol was quantified in M2 sample. All samples collected satisfy the test except M2 sample which contains a slight excess of methanol estimated of 14 ppm. This slight excess show that M2 sample wasn't well purified and this may be due to the difficulty of solvents complete removal

DOI

10.21608/bfsa.2023.300769

Keywords

Residual Solvents, HS-GC-FID, Metronidazole, Active Pharmaceutical Ingredient, Solvents-impurties

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

Khalil

Last Name

Hassam

MiddleName

Fateh Eddine

Affiliation

Quality control laboratory, WanyLab, 16002 Algiers, Algeria / Hikma Pharmaceuticals, 16002 Algiers, Algeria

Email

-

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 / Hikma Pharmaceuticals, 16002 Algiers, Algeria

Email

-

City

-

Orcid

-

Volume

46

Article Issue

1

Related Issue

41495

Issue Date

2023-06-01

Receive Date

2022-08-11

Publish Date

2023-06-01

Page Start

105

Page End

115

Print ISSN

1110-0052

Online ISSN

3009-7703

Article File

BFSA_Volume 46_Issue 1_Pages 105-115.pdf

PDF . 1.7MB

Link

https://bpsa.journals.ekb.eg/article_300769.html

Detail API

https://bpsa.journals.ekb.eg/service?article_code=300769

Order

300,769

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

RESIDUAL SOLVENTS ANALYSIS IN METRONIDAZOLE RAW MATERIAL USING HEAD SPACE GAS CHROMATOGRAPHY

Details

Type

Article

Created At

25 Dec 2024