Stability-Indicating Methods for the Determination of Luliconazole by TLC and HPTLC-Densitometry in Bulk Powder and Cream Dosage Form

Summary

Rapid and sensitive thin-layer chromatography (TLC) and high-performance thin-layer chromatography (HPTLC)—densitometry methods were used to separate, identify and quantify luliconazole (LUL), a new azole antifungal, in bulk and pharmaceutical dosage form. The proposed method can be used as a stability-indicating assay for the determination of LUL in the presence of its degradation products under forced degradation conditions (alkaline, acidic, oxidative, thermal and photolytic degradation). Complete separation was achieved by TLC and HPTLC on silica gel F₂₅₄ plates with the solvent system toluene—isopropanol—ammonia (90:10:0.5, v/v). The chromatographic bands were visualized under short-wave ultraviolet (UV) light, and the amount of LUL was determined by scanning densitometry at 297 nm using peak area. The linear ranges were 1–24 and 0.8–6 μg band⁻¹ with mean percentage recoveries of 99.84% ± 0.623 and 99.98% ± 1.405 for TLC and HPTLC, respectively. The methods were validated according to the International Conference on Harmonization (ICH) guidelines. The statistical analysis of the results revealed high accuracy and good precision. The suggested procedures could be used as a stability-indicating assay for the determination of LUL in drug substance and drug products in the presence of its degradation products.