Bioanalytical Method for Simultaneous Quantification of Itraconazole and Atorvastatin in Human Plasma.

Abstract

Introduction: Drug-drug interactions between statins and azole antifungal agents, due to the inhibition of the CYP3A4 enzyme by antifungals, increase the risk of adverse effects from statins. Thus, a precise bioanalytical method for quantifying Itraconazole and Atorvastatin in human plasma is essential.

Materials and methods: A liquid chromatographic method with protein precipitation and liquidliquid extraction was developed. Rosuvastatin calcium served as the internal standard. The method was validated per ICH M10 and USFDA guidelines and used to analyze spiked plasma samples.

Results: The method effectively separated Itraconazole, Atorvastatin, and the internal standard without plasma interference. It achieved linear responses for each drug in the 0.1-3.0 μg/mL range with regression coefficients > 0.99. The RSD for within-run and between-run responses was < 5%, and the average recovery exceeded 64%.

Discussion: The method accurately and precisely measured each analyte at the LLOQ level (0.1 μg/mL). A sensitive and selective bioanalytical HPLC method was developed, validated, and applied for the simultaneous estimation of Itraconazole and Atorvastatin in human plasma.

Conclusion: This method ensures safe and effective co-administration of these medications in clinical practice, benefiting patient care.