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285671

A Reverse phase HPLC method Development and Validation of 2,4,6 Trifluro Benzoic acid and its impurities: A Key Raw Material Used In Preparation of Anti Migraine Drug Lasmiditan

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Last updated: 01 Jan 2025

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Abstract

A novel gradient reverse phase liquid chromatographic (RP-HPLC) method is developed and validated for the determination of purity of 2,4,6 Trifluro benzoic acid (TBA) in presence of its related impurities. TBA is very important key raw material used in the process development of Active Pharmaceutical Ingredient (API), Lasmiditan Hemisuccinate. The impurities formed during the synthesis of TBA will diminishes the pharmacological quality of the Lasmiditan Hemisuccinate. Hence, the stringent control of TBA and its related impurities were significantly important to achieve the niche quality of Lasmiditan Hemisuccinate. This HPLC method developed by using Zorbax SB-Aq, 5 µm, 4.6 x 250 mm column with mobile phase containing a gradient mixture of solvent A and B. The buffer is 0.1% triethyl amine solution is solvent A and acetonitrile, methanol, water in the ratio of 700:200:100 v/v/v solvent mixture is solvent B. The eluted compounds monitored at 205 nm. This method validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, limit of detection, limit of quantitation, precision, linearity, accuracy and system suitability

DOI

10.21608/ejchem.2023.155748.6738

Keywords

Keywords: 2, 4, 6 trifluro benzoic acid (TBA), Lasmiditan Hemisuccinate, HPLC-Development, validation

Authors

First Name

M. Maheswar

Last Name

Reddy

MiddleName

-

Affiliation

R&D Center (API), Uquifa India Private Limited, CSIR-IICT, D-112, Discovery Building, Tarnaka, Hyderabad, Telangana, India -50007

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Orcid

-

First Name

A.

Last Name

Raghavendra

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-

Affiliation

R&D Center (API), Uquifa India Private Limited, CSIR-IICT, D-112, Discovery Building, Tarnaka, Hyderabad, Telangana, India -50007

Email

-

City

-

Orcid

-

First Name

 B.

Last Name

Kishore

MiddleName

-

Affiliation

R&D Center (API), Uquifa India Private Limited, CSIR-IICT, D-112, Discovery Building, Tarnaka, Hyderabad, Telangana, India -50007

Email

-

City

-

Orcid

-

First Name

E.

Last Name

Venkat Reddy

MiddleName

-

Affiliation

R&D Center (API), Uquifa India Private Limited, CSIR-IICT, D-112, Discovery Building, Tarnaka, Hyderabad, Telangana, India -50007

Email

-

City

-

Orcid

-

First Name

D.

Last Name

Yakaiah

MiddleName

-

Affiliation

R&D Center (API), Uquifa India Private Limited, CSIR-IICT, D-112, Discovery Building, Tarnaka, Hyderabad, Telangana, India -50007

Email

-

City

-

Orcid

-

First Name

V.B.

Last Name

Surya Varma

MiddleName

-

Affiliation

R&D Center (API), Uquifa India Private Limited, CSIR-IICT, D-112, Discovery Building, Tarnaka, Hyderabad, Telangana, India -50007

Email

-

City

-

Orcid

-

First Name

T.

Last Name

Karthikeyan

MiddleName

-

Affiliation

R&D Center (API), Uquifa India Private Limited, CSIR-IICT, D-112, Discovery Building, Tarnaka, Hyderabad, Telangana, India -50007

Email

-

City

-

Orcid

-

First Name

A.N.

Last Name

Kishore Kumar Reddy

MiddleName

-

Affiliation

R&D Center (API), Uquifa India Private Limited, CSIR-IICT, D-112, Discovery Building, Tarnaka, Hyderabad, Telangana, India -50007

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-

City

-

Orcid

-

First Name

P. Vijay

Last Name

Bhaskar

MiddleName

-

Affiliation

R&D Center (API), Uquifa India Private Limited, CSIR-IICT, D-112, Discovery Building, Tarnaka, Hyderabad, Telangana, India -50007

Email

podarillu1@yahoo.co.in

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Orcid

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Volume

66

Article Issue

10

Related Issue

43169

Issue Date

2023-10-01

Receive Date

2022-08-11

Publish Date

2023-10-01

Page Start

49

Page End

53

Print ISSN

0449-2285

Online ISSN

2357-0245

Article File

EJCHEM_Volume 66_Issue 10_Pages 49-53.pdf

PDF . 440.3kB

Link

https://ejchem.journals.ekb.eg/article_285671.html

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https://ejchem.journals.ekb.eg/service?article_code=285671

Order

285,671

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Original Article

Type Code

297

Publication Type

Journal

Publication Title

Egyptian Journal of Chemistry

Publication Link

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

MainTitle

A Reverse phase HPLC method Development and Validation of 2,4,6 Trifluro Benzoic acid and its impurities: A Key Raw Material Used In Preparation of Anti Migraine Drug Lasmiditan

Details

Type

Article

Created At

30 Dec 2024