Estimation of Pioglitazone Hydrochloride in Bulk Drug and Pharmaceutical Dosage Forms by Hydrotropy Technique and Oxidative- Coupling Reaction

Two simple, selective, rapid, accurate, precise and cost-effective spectrophotometric methods for the determination of Pioglitazone Hydrochloride in bulk drug and in tablets have been developed and validated. In the first method (method A), hydrotropic solution of citric acid (0.1M) was employed as solubilizing agent to solubilize pioglitazone hydrochloride (poorly water soluble drug) fine powder and its tablet dosage form for spectrophotometric determination in UV region (hydrotropic technique). The maximum absorbance of pioglitazone hydrochloride in 0.1M citric acid solution by hydrotropic technique was found to be at 269 nm. The second method (method B) is based on the reaction of 3- methylbenzothiazolin-2-one hydrazone (MBTH) with pioglitazone hydrochloride in the presence of ferric chloride (oxidative-coupling reaction). The resulting green colored chromogen complex absorbs at (Lambda) max 667 nm. Beer's law was obeyed over the ranges 4-34, 5-35 μg/mL for method A and method B respectively. The limit of detection (LOD), limit of quantification (LOQ) and sandell's sensitivity values are reported. Both the methods were validated in accordance with ICH guidelines. The results of the analysis have been validated statistically. The methods have been successfully applied in the analysis of marketed formulations. No significant interference was observed from either hydrotropic agent or commonly used tablet additives with the assay procedure.