Articles Accepted

A novel, robust, and stability-indicating High-Performance Thin Layer Chromatography (HPTLC) method was developed and validated for the quantification of Inosine Pranobex in bulk and pharmaceutical formulation by applying the Quality by Design. The Box-Behnken design was employed for optimization of critical method parameters, ensuring systematic method development. The method was optimized by evaluating the impact of critical method variables such as mobile phase composition, saturation time, solvent front and band length on chromatographic performance. HPTLC plates pre-coated with silica gel 60 F254 were utilized as the stationary phase for accomplishing separation by using mobile phase containing Toluene: Methanol: Ethylacetate: Formic acid in a 6:2:2:0.5 V/V/V/V ratio. At 272 nm, densitometric analysis was conducted. Method was validated in accordance with guidelines, demonstrating specificity, linearity, precision, accuracy, robustness, limit of detection, limit of quantitation and assay. Forced degradation studies under acidic, basic, oxidative, thermal, neutral and photolytic conditions confirmed stability-indicating nature of method. The developed methodology efficiently separated the drug from its degradation products, ensuring its suitability for routine analysis. This work clearly displays the significance of the Quality by Design methodology in developing an extremely precise HPTLC method with improved system efficacy.