Abstract
DOI: 10.1002/sscp.202100037 The cover picture shows a reverse phase HPLC method development for Itraconazole using principles of analytical QbD with surface response curves indicating the results of multivariate analysis in present method conditions, where the retention time (RT) was impacted with mobile phase concentration and flow rate with negligible impact of pH of mobile phase and a non-linear correlation amongst the experimental variables. On the other hand, the response for theoretical plates indicated a linear correlation with the pH of water used in the mobile phase without much impact of other variables. To evaluate the suitability of the test method for rapid screening of formulations, polymeric amorphous dispersion films were prepared for Itraconazole using the solvent evaporation method at different drug concentrations and using two different grades of polymer HPMCAS. It was observed that amongst the drug concentrations and polymer grades studied, the highest clarity of the film was achieved at 10% drug loading with HPMCAS 912G which also resulted in a rapid and complete drug dissolution in less than 30 minutes indicative of supersaturation and prevention of recrystallization after formation of the polymeric amorphous dispersion film.
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