Simultaneous Quantitative Determination of Imidazole Antimycotics in Human Urine by using RPLC Technique

Abstract

Imidazoles are well known heterocyclic compounds having important feature of a variety
of medicinal agents. Studies with imidazole containing compounds are great importance in
the clinical use of drugs. The presence of imidazole group in the molecules of lanoconazole
(LCZ) and butoconazole (BCZ) is very important for its chemical and analytical behavior.
Target analytes were efficiently separated with a Pinnacle DB Cyano column (5 µm, 4.6 x
250 mm I.D.) and oxiconazole (OCZ) used as an internal standard. In this study, correlation
between the retention factors of the solutes and pH of the mobile phase was determined
at ten pH values in acetonitrile-water binary mixture. In optimization condition,
quantification of these drugs were performed in human urine. The linear responses were
observed over a wide concentration range (6.25.10-6-3.13.10-5 mol L-1 for LCZ and 6.32.10-6
- 2.53.10-5 mol L-1 for BCZ) in human urine. The method were validated by determining the
limits of detection (LODs, 2.01.10-6 - 5.50.10-7 mol L-1), the limits of quantification (LOQs,
6.08.10-6 - 1.67.10-6 mol L-1), recoveries (99.14%, 99.93%) and intra-day and inter-day
relative standard deviations (RSDs, <1%). The data presented in this report demonstrate a
rapid, sensitive and accurate method for the simultaneous analysis of LCZ and BCZ in
human urine for pharmacokinetic studies.