Bioanalytical Method for Simultaneous Quantification of Itraconazole and Atorvastatin in Human Plasma
Kunjan B Bodiwala1, Flora J Pujara1, Avinash D Khadela2
1Department of Pharmaceutical Chemistry and Quality Assurance, L. M. College of Pharmacy, Ahmedabad 380009, Gujarat, India.
Drug Metabolism and Bioanalysis
|July 23, 2026
Summary
A new bioanalytical method accurately quantifies Itraconazole and Atorvastatin in human plasma. This HPLC method ensures safe co-administration of these drugs, minimizing adverse effects from drug-drug interactions.
Area of Science:
- Analytical Chemistry
- Pharmacology
Background:
- Drug-drug interactions between azole antifungals and statins, mediated by CYP3A4 inhibition, pose risks.
- Accurate quantification of Itraconazole and Atorvastatin in human plasma is crucial for patient safety.
Purpose of the Study:
- To develop and validate a sensitive and selective bioanalytical method for simultaneous estimation of Itraconazole and Atorvastatin in human plasma.
Main Methods:
- A liquid chromatography (HPLC) method was developed using protein precipitation and liquid-liquid extraction.
- Rosuvastatin calcium was employed as the internal standard.
- The method was validated according to ICH M10 and USFDA guidelines.
Main Results:
- The method demonstrated effective separation of Itraconazole, Atorvastatin, and the internal standard without interference.
- Linear responses were observed in the 0.1-3.0 μg/mL range (R² > 0.99).
- Relative standard deviation (RSD) was <5%, with average recovery exceeding 64% and accurate quantification at the 0.1 μg/mL lower limit of quantification (LLOQ).
Conclusions:
- A validated, sensitive, and selective HPLC bioanalytical method for simultaneous quantification of Itraconazole and Atorvastatin in human plasma was successfully developed.
- This method supports safe and effective co-administration of these drugs in clinical settings, enhancing patient care.
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