Stability-indicating high-performance thin-layer chromatographic method for analysis of itraconazole in bulk drug and in pharmaceutical dosage form


Author(s): Shalin K. Parikh, Jayant B. Dave, Chhagan N. Patel, and Badmanaban Ramalingan

Background: A new, simple, selective, precise, and stability-indicating high-performance thin-layer chromatographic method has been established for analysis of itraconazole (ITZ) in the bulk drug and in pharmaceutical formulations. Separation was achieved on aluminium plate precoated with silica gel 60F254 using Toluene : Chloroform : Methanol [5 : 5 : 1.5 (v/v)] as mobile phase. Densitometric analysis was performed at 260 nm. Result: Compact bands of ITZ were obtained at Rf 0.52 ± 0.02. Linearity (R2 = 0.9978), limit of detection (180.29 ng/band), limit of quantification (546.34 ng/band), recovery (98–102%), and precision (≤0.51%) were satisfactory. Drug was not degraded under neutral and alkaline hydrolysis, UV and photolytic degradation, under-elevated temperature, and humidity. ITZ is degraded under acidic hydrolysis and oxidative condition; the degraded products were well resolved from individual bulk drug response. Developed method can effectively resolve drug from its excipients in capsule dosage form. The specificity of the method was confirmed by peak purity of resolved peak. Conclusion: The method can be applicable for routine analysis of ITZ in pharmaceutical formulation as stabilityindicating. Because the method can effectively separate the drug from its degradation products as well as excipients, it can be used as a stability-indicating method.