Efinaconazole: DoE Supported development and validation of quantitative HPTLC method and its application for assay of drug in solution, and microemulsion based formulations.
Simple and rapid HPTLC method using densitometric analysis was developed and validated for assay of Efinaconazole present in studied pharmaceutical formulation (solution, and microemulsion). Chromatographic conditions like concentration of organic phase, chromatographic chamber saturation time and development distance were optimized to obtain retardation factor (Rf) value in the acceptable range (0.2<Rf<0.8) using Box-Behnken experimental design to develop robust HPTLC method for assay of Efinaconazole. From different solutions provided for optimization by the Design Expert software, experimental conditions with desirability 1 or near to 1 were selected. Based on the criteria for Efinaconazole Rf between 0.2 to 0.8, desirability one was obtained, which gave the optimal composition of methanol in mobile phase along with toluene (9.0:1.0 v/v), development distance of 72 mm and chamber saturation time of 18 min. The optimized method was validated as per ICH guideline, and statistical analysis proved that the method is robust, specific (peak purity ≥ 0.9999), sensitive (LOD – 26.09 ng and LOQ - 78.29 ng), accurate (98.62-100.40 %) and precise (%RSD < 2.0 for Efinaconazole). The proposed HPTLC method provides simple and cost-effective tool for routine quantitative estimation of Efinaconazole in quality control laboratories.