Development and validation of spectrofluorometric method for determination of pioglitazone hcl in marketed and non-marketed pharmaceutical tablet dosage forms

Abstract

Pioglitazone hydrochloride is commonly used for the management of type-II diabetes. It is analyzed by various methods based on chromatographic techniques which are time and resource consuming. The objective of this study was to develop a simple, rapid, accurate, and cost-effective method for the analysis of pioglitazone hydrochloride in bulk and pharmaceutical dosage forms. In the present study, various experimental conditions were optimized according to USP and ICH guidelines. A solvent was selected based on the solubility while working wavelengths were selected based on the scan of a 1% solution, prepared in a selected solvent. Applicability of the method was assessed by the comparison of results with the developed method and methods reported for pioglitazone hydrochloride. The fluorescence intensity was measured in water/methanol solvent at 521 and at 260 nm for pioglitazone HCl excitation. Beerís law was obeyed in the concentration range of 0.02-0.06 μg/mL, with a good correlation coefficient of R2, equal to 0.9613 between fluorescence intensity and concentration. The limit of detection (LOD) and the limit of quantification (LOQ) were 0.0102 and 0.0309 μg/mL, respectively. The method is applicable for the determination of pioglitazone HCl in different dosage forms with an average recovery of 85.36 to103.0%.