Determination of Efinaconazole in Plasma using Validated LC-MS/MS Technique
Govindarajan Srinivasan1,2, Asharani Indira Viswambaran1
1Department of Chemistry, School of Advanced Sciences, Vellore Institute of Technology, Vellore, 632 014, Tamil Nadu, India.
A new LC-MS/MS method accurately quantifies efinaconazole in biological samples. This sensitive technique is crucial for pharmacokinetic and toxicology studies of the topical antifungal.
Area of Science:
- Analytical Chemistry
- Pharmacology
- Biochemistry
Background:
- Efinaconazole is a topical antifungal for toenail infections with low systemic absorption.
- Conventional quantification methods (HPTLC, HPLC) lack sensitivity for biological samples.
Purpose of the Study:
- Develop a rapid, specific, selective, and sensitive LC-MS/MS method for efinaconazole quantification in plasma.
- Utilize Fluconazole as an internal standard.
Main Methods:
- Chromatographic separation using a UPLC column with a specific mobile phase.
- Sample preparation via liquid-liquid extraction (LLE).
- Detection using heated electrospray ionization (HESI) in parallel reaction monitoring (PRM) mode.
Main Results:
- The method demonstrated linearity from 1 to 2000 pg/mL.
- High precision (<5% variance) and accuracy (99-103%) across QC levels.
- Confirmed long-term stability under various storage and handling conditions.
Conclusions:
- The validated LC-MS/MS method offers exceptional sensitivity, specificity, and robustness.
- Suitable for pharmacokinetic, toxicology, and clinical studies.
- Indispensable for drug development and in vitro testing (IVPT, IVRT).
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