Development and validation of analytical procedure for analysis of polyvinylpyrrolidone in tablets containing metformin hydrochloride and pioglitazone hydrochloride

Polyvinylpyrrolidone (PVP) is a common excipient in pharmaceutical formulations due to its inert, biocompatible, and multifunctional properties. However, its presence can impact drug release. This study aims to optimize the analysis method for determining PVP concentration in tablets containing a combination of metformin hydrochloride and pioglitazone hydrochloride. The research involved optimizing stationary and mobile phases using HPLC, detector optimization, sample preparation, and stability testing. Validation followed ICH guidelines, covering system suitability, specificity, linearity, accuracy, precision, detection and quantitation limits, range, and robustness. HPLC with a reverse-phase column, UV detector, and SEC column with RID detector were utilized. The optimized HPLC method with sodium nitrate and acetonitrile mobile phase (80:20) provided accurate results. PVP content in tested tablets was 3.91% and 4.12% by weight for PioMix and ActMet, respectively. The method demonstrated stability and robustness under deliberate changes. In conclusion, the validated HPLC method offers a reliable means for PVP analysis in tablets containing metformin HCl and pioglitazone HCl, which is suitable for quality control and regulatory compliance.