DefinePK

Abstract

The primary objective of this study was to develop and validate stability-indicating HPTLC and RP-HPLC methods for the estimation of luliconazole in bulk, tablet, and semisolid dosage forms. Both methods were designed to meet ICH guidelines, ensuring precision, accuracy, sensitivity, and specificity. In the HPTLC method, separation was achieved using silica gel 60 F254 plates with a methanol:toluene mobile phase, allowing clear resolution of luliconazole from excipients and degradation products. The RP-HPLC method utilized a C18 column with an acetonitrile-water mobile phase (pH 3.5 adjusted with orthophosphoric acid), achieving excellent separation and reproducibility. Force degradation studies subjected luliconazole to hydrolytic (acidic and basic), oxidative, thermal, and photolytic conditions. Clear degradation peaks confirmed the drug’s susceptibility to stress while demonstrating the specificity of the methods, as excipients did not interfere with the analysis. Validation parameters—system suitability, robustness, accuracy, precision, and linearity—were within ICH-specified limits. Accelerated stability studies on semisolid dosage forms over six months revealed no significant degradation, indicating the formulation’s stability under recommended storage conditions. Overall, the HPTLC method provided a rapid, cost-effective option for routine analysis, while the RP-HPLC method offered higher sensitivity, precision, and robustness. In conclusion, the developed HPTLC and RP-HPLC methods are reliable, efficient, and suitable for regular quality control and stability studies of luliconazole across various dosage forms, ensuring consistent product quality and regulatory compliance throughout the shelf life