Development and Validation of a Stability-Indicating UPLC Method for the Determination of Hexoprenaline in Injectable Dosage Form Using AQbD Principles

A novel and efficient stability-indicating, reverse phase ultra-performance liquid chromatographic (UPLC<sup>®</sup>) analytical method was developed and validated for the determination of hexoprenaline in an injectable dosage form. The development of the method was performed using analy...

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Autores principales:	Jesús Alberto Afonso Urich, Viktoria Marko, Katharina Boehm, Raymar Andreína Lara García, Dalibor Jeremic, Amrit Paudel
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	hexoprenaline analytical quality by design (AQbD) design of experiment stability-indicating method ultra-performance liquid chromatography Organic chemistry QD241-441
Acceso en línea:	https://doaj.org/article/c5c7ac1c3ef7426292f13b5334493a9a
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spelling	oai:doaj.org-article:c5c7ac1c3ef7426292f13b5334493a9a2021-11-11T18:34:20ZDevelopment and Validation of a Stability-Indicating UPLC Method for the Determination of Hexoprenaline in Injectable Dosage Form Using AQbD Principles10.3390/molecules262165971420-3049https://doaj.org/article/c5c7ac1c3ef7426292f13b5334493a9a2021-10-01T00:00:00Zhttps://www.mdpi.com/1420-3049/26/21/6597https://doaj.org/toc/1420-3049A novel and efficient stability-indicating, reverse phase ultra-performance liquid chromatographic (UPLC<sup>®</sup>) analytical method was developed and validated for the determination of hexoprenaline in an injectable dosage form. The development of the method was performed using analytical quality by design (AQbD) principles, which are aligned with the future requirements from the regulatory agencies using AQbD principles. The method was developed by assessing the impact of ion pairing, the chromatographic column, pH and gradient elution. The development was achieved with a Waters Acquity HSS T3 (50 × 2.1 mm i.d., 1.8 µm) column at ambient temperature, using sodium dihydrogen phosphate 5 mM + octane-1-sulphonic acid sodium salt 10 mM buffer pH 3.0 (Solution A) and acetonitrile (Solution B) as mobile phases in gradient elution (t = 0 min, 5% B; t = 1 min, 5% B; t = 5 min, 50% B; t = 7 min, 5% B; t = 10 min, 5% B) at a flow rate of 0.5 mL/min and UV detection of 280 nm. The linearity was proven for hexoprenaline over a concentration range of 3.50–6.50 µg/mL (R<sup>2</sup> = 0.9998). Forced degradation studies were performed by subjecting the samples to hydrolytic (acid and base), oxidative, and thermal stress conditions. Standard solution stability was also performed. The proposed validated method was successfully used for the quantitative analysis of bulk, stability and injectable dosage form samples of the desired drug product. Using the AQbD principles, it is possible to generate methodologies with enhanced knowledge, which can eventually lead to a reduced regulatory risk, high quality data and lower operational costs.Jesús Alberto Afonso UrichViktoria MarkoKatharina BoehmRaymar Andreína Lara GarcíaDalibor JeremicAmrit PaudelMDPI AGarticlehexoprenalineanalytical quality by design (AQbD)design of experimentstability-indicating methodultra-performance liquid chromatographyOrganic chemistryQD241-441ENMolecules, Vol 26, Iss 6597, p 6597 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	hexoprenaline analytical quality by design (AQbD) design of experiment stability-indicating method ultra-performance liquid chromatography Organic chemistry QD241-441
spellingShingle	hexoprenaline analytical quality by design (AQbD) design of experiment stability-indicating method ultra-performance liquid chromatography Organic chemistry QD241-441 Jesús Alberto Afonso Urich Viktoria Marko Katharina Boehm Raymar Andreína Lara García Dalibor Jeremic Amrit Paudel Development and Validation of a Stability-Indicating UPLC Method for the Determination of Hexoprenaline in Injectable Dosage Form Using AQbD Principles
description	A novel and efficient stability-indicating, reverse phase ultra-performance liquid chromatographic (UPLC<sup>®</sup>) analytical method was developed and validated for the determination of hexoprenaline in an injectable dosage form. The development of the method was performed using analytical quality by design (AQbD) principles, which are aligned with the future requirements from the regulatory agencies using AQbD principles. The method was developed by assessing the impact of ion pairing, the chromatographic column, pH and gradient elution. The development was achieved with a Waters Acquity HSS T3 (50 × 2.1 mm i.d., 1.8 µm) column at ambient temperature, using sodium dihydrogen phosphate 5 mM + octane-1-sulphonic acid sodium salt 10 mM buffer pH 3.0 (Solution A) and acetonitrile (Solution B) as mobile phases in gradient elution (t = 0 min, 5% B; t = 1 min, 5% B; t = 5 min, 50% B; t = 7 min, 5% B; t = 10 min, 5% B) at a flow rate of 0.5 mL/min and UV detection of 280 nm. The linearity was proven for hexoprenaline over a concentration range of 3.50–6.50 µg/mL (R<sup>2</sup> = 0.9998). Forced degradation studies were performed by subjecting the samples to hydrolytic (acid and base), oxidative, and thermal stress conditions. Standard solution stability was also performed. The proposed validated method was successfully used for the quantitative analysis of bulk, stability and injectable dosage form samples of the desired drug product. Using the AQbD principles, it is possible to generate methodologies with enhanced knowledge, which can eventually lead to a reduced regulatory risk, high quality data and lower operational costs.
format	article
author	Jesús Alberto Afonso Urich Viktoria Marko Katharina Boehm Raymar Andreína Lara García Dalibor Jeremic Amrit Paudel
author_facet	Jesús Alberto Afonso Urich Viktoria Marko Katharina Boehm Raymar Andreína Lara García Dalibor Jeremic Amrit Paudel
author_sort	Jesús Alberto Afonso Urich
title	Development and Validation of a Stability-Indicating UPLC Method for the Determination of Hexoprenaline in Injectable Dosage Form Using AQbD Principles
title_short	Development and Validation of a Stability-Indicating UPLC Method for the Determination of Hexoprenaline in Injectable Dosage Form Using AQbD Principles
title_full	Development and Validation of a Stability-Indicating UPLC Method for the Determination of Hexoprenaline in Injectable Dosage Form Using AQbD Principles
title_fullStr	Development and Validation of a Stability-Indicating UPLC Method for the Determination of Hexoprenaline in Injectable Dosage Form Using AQbD Principles
title_full_unstemmed	Development and Validation of a Stability-Indicating UPLC Method for the Determination of Hexoprenaline in Injectable Dosage Form Using AQbD Principles
title_sort	development and validation of a stability-indicating uplc method for the determination of hexoprenaline in injectable dosage form using aqbd principles
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/c5c7ac1c3ef7426292f13b5334493a9a
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Development and Validation of a Stability-Indicating UPLC Method for the Determination of Hexoprenaline in Injectable Dosage Form Using AQbD Principles

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