Novel UV and visible spectrophotometric methods for the estimation of pioglitazone hydrochloride in bulk drug and pharmaceutical dosage forms

摘要

Two simple, selective, rapid, accurate, precise and cost-effective spectrophotometric methods for the determination of Pioglitazone Hydrochloride (PIO) in bulk drug and in tablets have been developed and validated. First method (method A) is based on the measurement of absorbance of PIO in methanol: 0.1M HCl: water (1:3:1) by cosolvancy technique at 269.2 nm. The second method (method B) is based on the measurement of absorbance of bluish green coloured chromogen complex at 765 nm which is formed by reaction of PIO with ferric chloride and potassium ferricyanide (redox technique). Beer's law was obeyed over the ranges 10-45, 50-350 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. All 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 the excipients commonly used as pharmaceutical aids with the assay procedure.