A UHPLC–MS/MS Method for Therapeutic Drug Monitoring of Aciclovir and Ganciclovir in Plasma and Dried Plasma Spots
Abstract
:1. Introduction
2. Materials and Methods
2.1. Chemicals and Reagents
2.2. Calibration Curve, Quality Control, and Stock Solution Preparation
2.3. Human Samples
2.4. Sample Preparation
2.4.1. Extraction from Plasma
2.4.2. Extraction from Dried Plasma Spots (DPS)
2.5. Chromatographic Conditions
2.6. MS/MS Conditions
2.7. Method Validation
2.7.1. Selectivity
2.7.2. Carry-Over
2.7.3. Matrix Effects and Extraction Recoveries
2.7.4. Linearity
2.7.5. Precision, Accuracy, and LLOQ
2.7.6. Stability
2.8. Statistical Analyses
3. Results
3.1. Methods Development
3.2. Method Validation
3.3. Clinical Application and Method Comparison
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Plasma | ||||||
INTER-DAY | ||||||
Ganciclovir | Aciclovir | |||||
SD (σ) | CV% | Accuracy% | SD (σ) | CV% | Accuracy% | |
LLOQ | 0.02 | 14% | 9% | 0.02 | 13% | 13% |
QC low | 0.00 | 13% | 8% | 0.00 | 13% | −14% |
QC medium | 0.03 | 14% | −6% | 0.03 | 8% | −12% |
QC high | 0.42 | 9% | −6% | 0.42 | 6% | −11% |
INTRA-DAY | ||||||
Ganciclovir | Aciclovir | |||||
SD (σ) | CV% | Accuracy% | SD (σ) | CV% | Accuracy% | |
LLOQ | 0.01 | 5% | 10% | 0.01 | 9% | 13% |
QC low | 0.00 | 6% | 15% | 0.00 | 8% | −14% |
QC medium | 0.02 | 7% | 2% | 0.02 | 5% | −11% |
QC high | 0.19 | 4% | −3% | 0.34 | 4% | −12% |
DPS | ||||||
INTER-DAY | ||||||
Ganciclovir | Aciclovir | |||||
SD (σ) | CV% | Accuracy% | SD (σ) | CV% | Accuracy% | |
LLOQ | 0.08 | 14% | 12% | 0.02 | 13% | 15% |
QC low | 0.09 | 13% | 14% | 001 | 15% | 13% |
QC medium | 0.01 | 2% | 1% | 006 | 1% | −15% |
QC high | 0.01 | 4% | −9% | 001 | 4% | −12% |
INTRA-DAY | ||||||
Ganciclovir | Aciclovir | |||||
SD (σ) | CV% | Accuracy% | SD (σ) | CV% | Accuracy% | |
LLOQ | 0.05 | 14% | 13% | 0.04 | 10% | 12% |
QC low | 0.07 | 13% | 13% | 0.08 | 9% | 15% |
QC medium | 0.05 | 6% | 2% | 0.07 | 6% | −15% |
QC high | 0.01 | 2% | −6% | 0.01 | 3% | −15% |
Ganciclovir | Aciclovir | ||
---|---|---|---|
T+25 °C | |||
15 days | 15 days | ||
QC low | 10% (7%) | QC low | 11% (2%) |
QC medium | 0.5% (2%) | QC medium | 4% (2%) |
QC high | 2% (2%) | QC high | 5% (4%) |
30 days | 30 days | ||
QC low | 10% (9%) | QC low | 11% (10%) |
QC medium | 6% (5%) | QC medium | 4% (6%) |
QC high | 5% (4%) | QC high | 9% (5%) |
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Pigliasco, F.; Cafaro, A.; Simeoli, R.; Barco, S.; Magnasco, A.; Faraci, M.; Tripodi, G.; Goffredo, B.M.; Cangemi, G. A UHPLC–MS/MS Method for Therapeutic Drug Monitoring of Aciclovir and Ganciclovir in Plasma and Dried Plasma Spots. Biomedicines 2021, 9, 1379. https://doi.org/10.3390/biomedicines9101379
Pigliasco F, Cafaro A, Simeoli R, Barco S, Magnasco A, Faraci M, Tripodi G, Goffredo BM, Cangemi G. A UHPLC–MS/MS Method for Therapeutic Drug Monitoring of Aciclovir and Ganciclovir in Plasma and Dried Plasma Spots. Biomedicines. 2021; 9(10):1379. https://doi.org/10.3390/biomedicines9101379
Chicago/Turabian StylePigliasco, Federica, Alessia Cafaro, Raffaele Simeoli, Sebastiano Barco, Alberto Magnasco, Maura Faraci, Gino Tripodi, Bianca Maria Goffredo, and Giuliana Cangemi. 2021. "A UHPLC–MS/MS Method for Therapeutic Drug Monitoring of Aciclovir and Ganciclovir in Plasma and Dried Plasma Spots" Biomedicines 9, no. 10: 1379. https://doi.org/10.3390/biomedicines9101379