A rapid method for determination of rosuvastatin in blood plasma with supported liquid extraction

Introduction: Accurate measurement of rosuvastatin in plasma is critical for effective patient management and treatment monitoring following myocardial infarction (MI). Expensive solid-phase extraction (SPE) and time-consuming liquid–liquid extraction (LLE) have been established for quantifying rosu...

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Main Authors: Tjaša Dermota, Mojca Božič Mijovski, Jurij Trontelj
Format: Article
Language:English
Published: Elsevier 2025-04-01
Series:Journal of Mass Spectrometry and Advances in the Clinical Lab
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Online Access:http://www.sciencedirect.com/science/article/pii/S2667145X25000094
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author Tjaša Dermota
Mojca Božič Mijovski
Jurij Trontelj
author_facet Tjaša Dermota
Mojca Božič Mijovski
Jurij Trontelj
author_sort Tjaša Dermota
collection DOAJ
description Introduction: Accurate measurement of rosuvastatin in plasma is critical for effective patient management and treatment monitoring following myocardial infarction (MI). Expensive solid-phase extraction (SPE) and time-consuming liquid–liquid extraction (LLE) have been established for quantifying rosuvastatin. Supported liquid extraction (SLE) could offer a rapid, cost-effective alternative. Objectives: This study aimed to develop and validate a rapid, cost-effective, accurate, and precise method for quantifying rosuvastatin in high-dose plasma samples from patients following MI. Methods: Rosuvastatin was extracted from EDTA plasma using SLE and quantified with LC-MS/MS with positive electrospray ionization. The method was validated according to ICH M10 guidelines, focusing on selectivity, matrix effect, accuracy, precision, linearity, and carryover. Rosuvastatin-D6 was used as an internal standard. Additionally, thirty plasma samples from patients on high-dose rosuvastatin therapy (20 or 40 mg/day) following MI were analyzed by both LLE and SLE methods and compared. Results: The method was successfully validated, demonstrating linearity across a range of 0.1 ng/mL to 50 ng/mL. Compared to the LLE method, SLE achieved superior extraction recovery (96.3 % vs. 60 %) and precision (RSD: 11.9 % vs. 13.6 %) at 0.3 ng/mL rosuvastatin, with a lower absolute matrix effect (12.7 % vs. −36.7 %). Accuracy was comparable (109.3 % vs. 92.8 %). Although SLE involves higher initial costs, it significantly enhances throughput, reduces solvent usage, and minimizes contamination and equipment wear. Conclusion: This study validates SLE as a superior method for quantifying rosuvastatin in plasma, outperforming LLE in recovery, reproducibility, and automation. SLE offers greater accuracy and reliability, making it ideal for high-throughput applications.
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spelling doaj-art-b595a2641e4b494d995cc34407dd3d1e2025-08-20T03:48:47ZengElsevierJournal of Mass Spectrometry and Advances in the Clinical Lab2667-145X2025-04-0136293610.1016/j.jmsacl.2025.04.003A rapid method for determination of rosuvastatin in blood plasma with supported liquid extractionTjaša Dermota0Mojca Božič Mijovski1Jurij Trontelj2University Medical Centre Ljubljana, Slovenia; Faculty of Pharmacy, University of Ljubljana, Slovenia; Corresponding author at: University Medical Centre Ljubljana, Zaloska 7, 1000 Ljubljana, Slovenia.University Medical Centre Ljubljana, SloveniaFaculty of Pharmacy, University of Ljubljana, SloveniaIntroduction: Accurate measurement of rosuvastatin in plasma is critical for effective patient management and treatment monitoring following myocardial infarction (MI). Expensive solid-phase extraction (SPE) and time-consuming liquid–liquid extraction (LLE) have been established for quantifying rosuvastatin. Supported liquid extraction (SLE) could offer a rapid, cost-effective alternative. Objectives: This study aimed to develop and validate a rapid, cost-effective, accurate, and precise method for quantifying rosuvastatin in high-dose plasma samples from patients following MI. Methods: Rosuvastatin was extracted from EDTA plasma using SLE and quantified with LC-MS/MS with positive electrospray ionization. The method was validated according to ICH M10 guidelines, focusing on selectivity, matrix effect, accuracy, precision, linearity, and carryover. Rosuvastatin-D6 was used as an internal standard. Additionally, thirty plasma samples from patients on high-dose rosuvastatin therapy (20 or 40 mg/day) following MI were analyzed by both LLE and SLE methods and compared. Results: The method was successfully validated, demonstrating linearity across a range of 0.1 ng/mL to 50 ng/mL. Compared to the LLE method, SLE achieved superior extraction recovery (96.3 % vs. 60 %) and precision (RSD: 11.9 % vs. 13.6 %) at 0.3 ng/mL rosuvastatin, with a lower absolute matrix effect (12.7 % vs. −36.7 %). Accuracy was comparable (109.3 % vs. 92.8 %). Although SLE involves higher initial costs, it significantly enhances throughput, reduces solvent usage, and minimizes contamination and equipment wear. Conclusion: This study validates SLE as a superior method for quantifying rosuvastatin in plasma, outperforming LLE in recovery, reproducibility, and automation. SLE offers greater accuracy and reliability, making it ideal for high-throughput applications.http://www.sciencedirect.com/science/article/pii/S2667145X25000094SLESupported Liquid ExtractionLLERosuvastatinLC-MS/MS
spellingShingle Tjaša Dermota
Mojca Božič Mijovski
Jurij Trontelj
A rapid method for determination of rosuvastatin in blood plasma with supported liquid extraction
Journal of Mass Spectrometry and Advances in the Clinical Lab
SLE
Supported Liquid Extraction
LLE
Rosuvastatin
LC-MS/MS
title A rapid method for determination of rosuvastatin in blood plasma with supported liquid extraction
title_full A rapid method for determination of rosuvastatin in blood plasma with supported liquid extraction
title_fullStr A rapid method for determination of rosuvastatin in blood plasma with supported liquid extraction
title_full_unstemmed A rapid method for determination of rosuvastatin in blood plasma with supported liquid extraction
title_short A rapid method for determination of rosuvastatin in blood plasma with supported liquid extraction
title_sort rapid method for determination of rosuvastatin in blood plasma with supported liquid extraction
topic SLE
Supported Liquid Extraction
LLE
Rosuvastatin
LC-MS/MS
url http://www.sciencedirect.com/science/article/pii/S2667145X25000094
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