Quality by Design-Based Optimization and Validation of a High-Performance Thin-Layer Chromatography Method for the Estimation of Rivaroxaban in Bulk and Its Pharmaceutical Dosage Form

Abstract

The objective of this study was to develop a new rapid and robust high-performance thin-layer chromatographic (HPTLC) method for the estimation of rivaroxaban (RRB) in tablet dosage form using a quality by design approach. Chromatography was performed using a pre-coated silica gel aluminum plate 60 F254 (10 cm × 10 cm) as the stationary phase and toluene-methanol (7:3, V/V) as the mobile phase. Detection was carried out at 250 nm. The linear regression analysis data for the calibration plots showed r2 > 0.99 with a concentration range from 100–600 ng per band. A Box–Behnken experimental design with a response surface methodology was applied to study the effects of chamber saturation time, band length, and solvent front on the RF value and area of RRB. The RF value was predicted to be 0.63 ± 0.05 for RRB to optimize the chromatographic conditions based on the preliminary trials. The optimized HPTLC method was validated according to the International Conference on Harmonization (ICH) guideline Q2 (R1). The results of this study indicate that the quality by design (QbD) concept could be effectively applied to optimize a HPTLC method with a minimum number of experimental runs. The developed HPTLC method was successfully applied for routine analysis of RRB in tablet dosage form.