Quality by design (QbD) based development and validation of HPTLC method for simultaneous estimation of ofloxacin and flavoxate hydrochloride: forced degradation study

The purpose of this work was to develop a rapid and reliable HPTLC method for estimating and validating Ofloxacin and Flavoxate by applying QbD techniques. Ofloxacin is used in the treatment of pneumonia and bronchitis while flavoxate in the treatment of overactive bladder. The study utilised a Box-Behnken experimental design utilising response surface methods to examine the impact of migration distance, band length, and chromatographic chamber saturation time on Rf values. Based on the preliminary trials, the Rf values for ofloxacin and flavoxate hydrochloride were observed to be between 0.13 and 0.83 under the chromatographic conditions. The optimized chromatographic conditions included a saturation time of 10 min, a band length of 6mm, a solvent front of 80mm, and a mobile phase composed of methanol: ethyl acetate: Chloroform: Ammonia in a ratio of 3:6:1:0.1 v/v. In compliance with International Conference on Harmonization (ICH) rule Q2 (R1), the enhanced HPTLC method was validated. The study's findings demonstrate that optimizing the HPTLC method with the number of speculative runs can be accomplished through the effective application of quality by design. For the regular analysis of ofloxacin and flavoxate hydrochloride in combination tablet formulation, the validated HPTLC method worked well.