Work

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

Year: 2025

Type: article

Abstract: 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.

Source: Journal of Mass Spectrometry and Advances in the Clinical Lab

DOI: 10.1016/j.jmsacl.2025.04.003

Authors: Tjaša Dermota, Mojca Božič Mijovski, Jurij Trontelj

Institutions: University of Ljubljana, Ljubljana University Medical Centre

Language: English

Topic: Analytical Methods in Pharmaceuticals

Subfield: Analytical Chemistry

Field: Chemistry

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $900