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 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.