QUANTITATIVE ANALYSIS OF ITRACONAZOLE IN BULK, MARKETED, AND NANO FORMULATION BY VALIDATED, STABILITY INDICATING HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHY

Abstract

A stability-indicating high-performance thin-layer chromatographic (HPTLC) method was developed and validated for quantifying Itraconazole (Itz) in bulk drug, marketed formulation, and an in-house formulation comprised of lipidic-nano particle incorporated into vaginal gel. Aluminum plates precoated with silica gel 60 F-254 were used for TLC with Toulene:Ethyl acetate:Ammonia (1:5:0.1 v/v) as a mobile phase. The densitometric analysis was carried out at 266 nm using a Camag TLC scanner that generated compact spots for Itz (R f =0.77 ± 0.02). The regression analysis data for the calibration curve exhibited good linearity (r2 = 0.996 ± 0.0058). The LOD and LOQ values were found to be 14.29 ng spot−1 and 43.31 ng spot−1, respectively, while their recovery (99.65–100.23%) and precision (1.47%) were found to be satisfactory. Itraconazole was also subjected to forced stress conditions such as hydrolysis (acid and alkali), oxidation, dry and wet heat degradation, and photo degradation. The degradants were further characterized by NMR and Mass spectroscopy and compared with neat drug. Statistical analysis revealed that the developed method has potential for routine analysis of Itz in various formulations. It is well suited for quality control and study of pharmaceutical parameters such as release profile, loading, and entrapment in lipidic nanoparticle formulation.