DEVELOPMENT AND VALIDATION OF ANALYTICAL PROCEDURE FOR ANALYSIS OF POLYVINYLPYRROLIDONE IN TABLETS CONTAINING METFORMIN HYDROCHLORIDE AND PIOGLITAZONE HYDROCHLORIDE

• Main Author: Paryanti, Sri
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/81085
• Institution: Institut Teknologi Bandung

Polyvinylpyrrolidone (PVP) is a functional excipient that is often used in pharmaceutical formulations because of its inert, biocompatible and multifunctional properties. However, the use of PVP in pharmaceutical formulations can also affect drug release from the formulation. This research aimed to optimize the analysis method for determining the concentration of polyvinylpyrrolidone (PVP) in tablets containing a combination of metformin hydrochloride and pioglitazone hydrochloride. The research design involved optimization of the stationary phase and mobile phase using HPLC, as well as detector optimization based on the properties of the analyte. Sample preparation optimization and stability testing were also conducted. The validation of the method was performed according to ICH guidelines, including system suitability, specificity, linearity, accuracy, precision, detection and quantitation limits, range, and robustness. The study utilized HPLC with a reversephase column and UV detector, as well as SEC column with RID detector to obtain an optimal method before conducting the validation of the analysis method. The optimized and validated HPLC method using a reverse-phase column with a mobile phase of sodium nitrate and acetonitrile provided accurate and robust results for PVP analysis in tablets containing metformin HCl and pioglitazone HCl. The method showed satisfactory performance in terms of system suitability, specificity, precision, accuracy, linearity, detection and quantitation limits, and robustness. The method also demonstrated stability and robustness under intentional changes in column temperature, flow rate, and mobile phase composition. The PVP content in the tested tablets was determined to be 3.91% ± 0.002 and 4.12% ± 0.010 for test tablet (Tablet A) and reference tablet (Tablet B), respectively. In conclusion, the optimized and validated HPLC method provides a reliable and accurate means of analyzing PVP in tablets containing metformin HCl and pioglitazone HCl. The method can be used for quality control and regulatory compliance purposes.