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

TL;DR

This study introduces a faster and more reliable method for measuring rosuvastatin in blood plasma, which is important for monitoring patients after heart attacks.

Contribution

The study validates supported liquid extraction (SLE) as a superior alternative to traditional methods for rosuvastatin quantification.

Findings

SLE showed better extraction recovery (96.3%) compared to LLE (60%) at 0.3 ng/mL rosuvastatin.

SLE had a lower matrix effect (12.7%) and higher precision (RSD: 11.9%) than LLE.

SLE consistently produced 14.6% higher rosuvastatin responses in clinical samples.

Abstract

•SLE outperforms LLE in most validation parameters.•SLE demonstrates linearity across a range of 0.1 – 50 ng/mL.•SLE has better extraction recovery and reproducibility than LLE.•SLE offers better cleanup with lower matrix effect and cleaner extracts.•SLE consistently showed 14.6% higher rosuvastatin responses in clinical samples.

SLE outperforms LLE in most validation parameters.

SLE demonstrates linearity across a range of 0.1 – 50 ng/mL.

SLE has better extraction recovery and reproducibility than LLE.

SLE offers better cleanup with lower matrix effect and cleaner extracts.

SLE consistently showed 14.6% higher rosuvastatin responses in clinical samples.

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.

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.

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.

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.

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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