Analytical Method Development and Validation of a UV-Spectrophotometric Technique for Pioglitazone HCL Estimation in Bulk and Polymeric Nanoparticles

The type 2 diabetes drug pioglitazone is encapsulated in polymeric (Chitosan/PEG blended PLGA) nanoparticles utilizing solvent evaporation methods. The current research aimed to develop and validate an accessible, accurate, fast, and commercial UV spectrophotometric approach for assessing Pioglitazone in bulk and polymeric nanoparticles. In the estimation method that involves a pH 7.4 phosphate buffer, the maximum absorbance of Pioglitazone is reported to be 269 nm. With a correlation coefficient of 0.999, the drug exhibits linearity in the concentration series of 5–60 µg mL-1. The proposed technique is validated as per ICH guidelines for linearity, accuracy, precision, and ruggedness. When the proposed technology is used in nano-formulation, the percent amount of drug estimated to be 99.35% agreed well with the label claim. Recovery experiments at three distinct levels, 50%, 75%, and 100% are used to test the method's accuracy. The recovery rate is estimated to be between 98.91% and 99.11%. The low percent relative standard deviation (RSD) value indicates the method's accuracy and reproducibility. The method's repeatability, intraday, and interday precision are all examined. The approach is precise if the percent RSD value is less than 2. With the assistance of two analysts, the ruggedness of the suggested method is investigated. For the scheduled examination of Pioglitazone in bulk and polymeric nanoparticles, the above process has been developed and validated and proved to be a quick and cost-effective quality-control tool in pharmaceuticals. © 2024 Wiley-VCH GmbH.