Design of Experiments-Assisted Development and Validation of an HPTLC Method for Simultaneous Quantification of Silodosin and Tadalafil in Pharmaceutical Formulation
Abstract
Abstract A robust and efficient high-performance thin-layer chromatographic (HPTLC) method was developed for the simultaneous quantification of silodosin and tadalafil in pharmaceutical formulations. Method optimization was performed using a Design of Experiments (DoE) approach based on central composite design, enabling systematic evaluation of critical chromatographic variables including chamber saturation time, migration distance, and ammonia concentration. Chromatographic separation was achieved on silica gel 60 F254 plates using a mobile phase of ethyl acetate, ammonia, and methanol (9:1:0.3, v/v/v), with densitometric detection at 260 nm. The method exhibited excellent linearity across the studied concentration ranges, with strong correlation coefficients. Accuracy studies demonstrated recoveries within acceptable limits, while precision assessment indicated low variability, confirming method reproducibility. Sensitivity evaluation showed that the method is capable of detecting and quantifying analytes at low levels. The DoE strategy enabled identification of an optimal design space, enhancing method robustness and reducing experimental variability compared to conventional optimization approaches. The validated method is simple, cost-effective, and suitable for routine quality control analysis of combined pharmaceutical formulations.
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