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DEVELOPMENT AND VALIDATION OF GREEN HPTLC METHOD FOR SIMULTANEOUS DETERMINATION OF DAPAGLIFLOZIN AND LINAGLIPTIN IN COMBINED DOSAGE FORM

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Last updated: 25 Dec 2024

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Abstract

A simple, accurate, rapid, sensitive and green high performance thin layer chromatography (HPTLC) technique was developed for the simultaneous determination of Dapagliflozin (DAPA) and Linagliptin (LINA) in pure and pharmaceutical dosage form. Chromatographic separation of both the drugs was performed on precoated silica gel aluminium plate 60 F 254, (10 X 10), 100 μm thickness; using the solvent system chloroform: methanol: ethyl Acetate: 1 % formic acid (3:4:3:0.5, v/v). Short-wave ultraviolet light at 224 nm was used to view the chromatographic bands. The proposed technique revealed compact bands with retention factor (Rf) values of 0.66 and 0.20, for DAPA and LINA, respectively. Calibration curves were polynomial in the concentration range of 3000-9000 ng/band for DAPA and 1500-4500 ng/band for LINA, with correlation coefficients of 0.995 and 0.996, respectively. The proposed method was validated with respect to ICH guideline. Green assessment of the developed HPTLC method was assessed using different green analytical chemistry metrics such as Analytical GREEness (AGREE), and Green Analytical Procedure Index (GAPI). The proposed method was applied for the analysis of drug in tablet formulation, and it can be used for routine quality control analysis.

DOI

10.21608/bfsa.2024.298376.2169

Keywords

Dapagliflozin, Linagliptin, HPTLC, Green assessment, validation

Authors

First Name

Dhyey

Last Name

Shah

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Affiliation

Department of Pharmaceutical Quality Assurance, Pioneer Pharmacy College, Vadodara, (Gujarat) India

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Orcid

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First Name

Dhananjay

Last Name

Meshram

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-

Affiliation

Department of Pharmaceutical Quality Assurance, Pioneer Pharmacy College, Vadodara, (Gujarat) India

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City

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Orcid

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First Name

Dhara

Last Name

Patel

MiddleName

-

Affiliation

Pioneer Pharmacy College

Email

patel.dhara.j@gmail.com

City

-

Orcid

0000-0001-8857-8795

First Name

Prasanna

Last Name

Pradhan

MiddleName

-

Affiliation

Department of Pharmaceutical Quality Assurance, Pioneer Pharmacy College, Vadodara, (Gujarat) India

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City

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Orcid

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First Name

Grishma

Last Name

Patel

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-

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Volume

47

Article Issue

2

Related Issue

51758

Issue Date

2024-12-01

Receive Date

2024-06-21

Publish Date

2024-12-01

Page Start

1,037

Page End

1,048

Print ISSN

1110-0052

Online ISSN

3009-7703

Link

https://bpsa.journals.ekb.eg/article_376351.html

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https://bpsa.journals.ekb.eg/service?article_code=376351

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376,351

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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

DEVELOPMENT AND VALIDATION OF GREEN HPTLC METHOD FOR SIMULTANEOUS DETERMINATION OF DAPAGLIFLOZIN AND LINAGLIPTIN IN COMBINED DOSAGE FORM

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Article

Created At

25 Dec 2024