NEW STABILITY INDICATING HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR DETERMINATION OF TEPOTINIB IN BULK AND TABLET DOSAGE FORM BY USING QBD APPROACH

Abstract

The Implementation of Quality by Design (QbD) principles in High-Performance Liquid Chromatography (HPLC) analysis ensures a systematic and scientific approach to method development, optimization, and validation. This approach focuses on understanding the relationship between Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs), enabling the design of robust and reliable analytical methods. By utilizing Design of Experiments (DoE), risk assessment, and robustness testing, QbD in HPLC facilitates the identification of optimal method conditions, ensuring accurate and precise results. This methodology enhances method transferability, scalability, and regulatory compliance, ultimately leading to improved product quality and reduced development timelines. The application of QbD in HPLC analysis demonstrates a proactive and holistic approach to analytical method development, aligning with regulatory guidelines and industry best practices So a simple, accurate, precise method was developed for the estimation of the Tepotinib in bulk and pharmaceutical dosage form by using QbD approach was developed. Chromatogram was run through Ascentis C18 Column, 100Å, 10 μm, 4.6 mm X 150 mm. Mobile phase containing 0.01N Kh2PO4: Acetonitrile taken in the ratio 55.3: 44.7(%v/v) was pumped through column at a flow rate of 0.95 ml/min. Temperature was maintained at 27.8°C. Optimized wavelength selected was 235nm. Retention time of Tepotinib was found to be 2.422 min. %RSD of the Tepotinib were and found to be 0.4 and 0.3 respectively. %Recovery was Obtained as 99.94% for Tepotinib. LOD, LOQ values were obtained from regression equations of Tepotinib were 0.02ppm, 0.06 ppm respectively. Regression equation of Tepotinib is y = 41599x + 9224.1.