QUALITY BY DESIGN (QBD) APPROACH TO DEVELOP STABILITY-INDICATING RP-HPLC METHOD DEVELOPMENT FOR PIOGLITAZONE AND GLIMEPIRIDE

Background and Objectives: A sper requisition of current regulatory requirements, a simple, rapid, and sensitive method by 33 factorial QbD approach was established and validated for Pioglitazone (PGZ) Glimepiride (GPR) by RP-HPLC. Method: A simple RP-HPLC method has been developed and validated with different parameters such as linearity, precision, repeatability, LOD, LOQ, accuracy as per International Conference for Harmonisation guidelines (Q2R1). Statistical data analysis was done for data obtained from different aliquots Runs on Agilent Tech. Gradient System with Autoinjector, UV (DAD) & Gradient Detector. Results: Equipped with Reverse Phase (Agilent) C18 column (4.6 mm × 100 mm; 2.5µm), a 20µl injection loop and UV730D Absorbance detector at 231nm wavelength and running chemstation 10.1 software and drugs along with degradants were separated via Methanol: (0.1% OPA) Water (70:30) of pH 3.2 as mobile phase setting flow rate 0.7 ml/min at ambient temperature. The developed method was found linear over the concentration range of 15-75 μg/ml for PGZ and 2-10 μg/ml for GPR, while detection and quantitation limit was found to be 1.39 μg/ml and 0.28 μg/ml as LOD and 3.85 μg/ml and 0.77 μg/ml respectively for PGZ and GPR. Conclusion: There are no interfering peaks underperformed degradation conditions. Therefore, a sensitive, robust, accurate, and stability-indicating method was developed with a high degree of practical utility.