ABSTRACT:
A simple, direct and accurate spectrophotometric method has been developed for the determination of pioglitazone hydrochloride (PGZ.HCl) in bulk drug and pharmaceutical dosage form by complex formation with bromocresol green (BCG). The method involves the formation of yellow ion-pair complexes between BCG reagent and PGZ in chloroform. The one formed complex ([PGZ]:[BCG] have maximum absorption at ?max 420 nm. The formed complexes ([PGZ]:[BCG]) was measured against the reagent blank prepared in the same manner. Variables were studied in order to optimize the reaction conditions. Molar absorptivity (e) was 14300 L.mol-1.cm-1. Beer’s law was obeyed in the concentration range of 0.3929-3.929 and 0.3929-39.29 µg.mL-1 in the present of 1x10-4 and 5x10-4 mol.L-1 of BCG, respectively, with good correlation coefficient (R2= 0.9986 and R2= 0.9995, respectively). The relative standard deviation did not exceed 4.4%. The limit of detection (LOD) and the limit of quantification (LOQ) were 0.055 and 0.170 µg.mL-1, respectively. The developed method is applicable for the determination of PGZ in pure and different dosage forms with the average assay of marketed formulations 99.1 to 101.0%, and average recovery of 99.5 to102.0%. The results are in good agreement with those obtained by the RP-HPLC reference method.