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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Elsevier
2025-04-01
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| 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. |
| format | Article |
| id | doaj-art-b595a2641e4b494d995cc34407dd3d1e |
| institution | Kabale University |
| issn | 2667-145X |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of Mass Spectrometry and Advances in the Clinical Lab |
| 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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