Use of Alizarin Red S as an Ion-Pair Reagent for the Spectrophotometric Assay of Fexofenadine in Pharmaceuticals and in Spiked Human Urine

Quality by Design (QbD) is a philosophy that refines the level of knowledge assocd. with a product that uses process understanding to deliver a product with the desired crit. quality attributes. The objective of this study was to develop an integrated multivariate QbD approach to develop and quantify the constituent concns. of pioglitazone hydrochloride (PGZ) drug in its pure and formulated forms. To facilitate studies investigating the detn. of PGZ in bulk drug and its pharmaceutical formulations, a rapid UPLC method was developed and validated for the detn. of PGZ accompanied by its degrdn. studies in different stress conditions. The method fulfilled validation criteria and was shown to be sensitive, with limits of detection (LOD) and quantitation (LOQ) of 0.01 and 0.05 μgmL-1, resp. The percent relative std. deviations for robustness and ruggedness were obsd. within the range of 0.1-1.74. The calibration graph was linear in the range of 0.05-300 μgmL-1. The applicability of the method was shown by anal. of formulated drug samples and spiked human urine. The proposed method can be used for routine anal. in quality controlled labs. for its bulk and formulated product and this is the first reported UPLC method for the assay of PGZ. [on SciFinder(R)