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UV Spectrophotometric Method Development and validation of vonoprazan fumarate in Bulk and pharmaceutical Dosage form; Green Profile Evaluation Via eco-scale And GAPI Tools

Article

Last updated: 01 Jan 2025

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Abstract

A novel, cost-effective, precise, and accurate UV spectrophotometric technique for determining vonoprazan fumarate, a first-in-class potassium-competitive acid blocker, in bulk and tablet medicinal dosage form was developed and validated. Quantitative measurements were taken at 230 nm using methanol and phosphate buffer (50:50 v/v) as a solvent. According to ICH criteria, the parameters of linearity, precision, accuracy, the limit of detection, and the limit of quantitation were investigated. The calibration graph was discovered to be linear over a concentration range of (2-30 g/mL) with a correlation coefficient (r = 0.9998). The proposed method's accuracy was validated using a percentage recovery of 99.48±0.347%, which demonstrated that it was highly accurate. The detection limit was 0.24 g/mL, and the quantification limit was 0.70 g/mL. The results showed that the technique is accurate, precise with relative standard deviation lower than 2%, while also being easy and inexpensive. The proposed method was successfully used to determine the drug in a pharmaceutical formulation without interference from excipients. The research proved that the proposed method can be used in conventional analysis

DOI

10.21608/ejchem.2022.161704.6948

Keywords

Vonoprazan Fumarate, Helicobacter pylori, Gastric cancer, proton pump inhibitors, Potassium competitive acid blockers, COVID-19

Authors

First Name

Ahmed

Last Name

Mohamed Saleh

MiddleName

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Affiliation

Department of pharmaceutical Chemisty, Faculty of pharmacy, Horus University, 34518, Egypt

Email

asaleh@horus.edu.eg

City

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Orcid

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First Name

Amira M.

Last Name

El-Kosasy

MiddleName

-

Affiliation

Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Ain Shams University, Abbassia, Cairo 11566, Egypt

Email

-

City

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Orcid

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First Name

Nermine V.

Last Name

Fares

MiddleName

-

Affiliation

Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Ain Shams University, Abbassia, Cairo 11566, Egypt

Email

-

City

-

Orcid

-

Volume

66

Article Issue

8

Related Issue

42250

Issue Date

2023-08-01

Receive Date

2022-09-09

Publish Date

2023-08-01

Page Start

141

Page End

148

Print ISSN

0449-2285

Online ISSN

2357-0245

Link

https://ejchem.journals.ekb.eg/article_270266.html

Detail API

https://ejchem.journals.ekb.eg/service?article_code=270266

Order

270,266

Type

Original Article

Type Code

297

Publication Type

Journal

Publication Title

Egyptian Journal of Chemistry

Publication Link

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

MainTitle

UV Spectrophotometric Method Development and validation of vonoprazan fumarate in Bulk and pharmaceutical Dosage form; Green Profile Evaluation Via eco-scale And GAPI Tools

Details

Type

Article

Created At

30 Dec 2024