Stability Indicating RP-HPLC Method For the e...

Stability Indicating RP-HPLC Method For the estimation of Vismodegib in Pharmaceutical formulation by QBD Approach

Author Name : Akanksha S. Waghmare, Dr. Ram S. Sakhare, Shruti V. Nidwanche

ABSTRACT Background: A simple and precise method was developed to accurately estimate the percentage of Vismodegib in both bulk and Pharmaceutical dosage forms. Materials & Methods: The chromatogram was processed using the Agilent C18 Column, which has dimensions of 150 x 4.6 mm and a particle size of 5 µm. The column was pumped with a mobile phase consisting of 0.01N KH2PO4 and Acetonitrile in a ratio of 51.3%v/v and 48.7%v/v, respectively, at a flow rate of 0.93 ml/min. The temperature was consistently maintained at 32.21°C. The chosen wavelength for optimization of the PDA Detector was 258.0 nm. The injection volume was optimized at 10.0 µl. Results: The method obeyed linearity in the range of 7.5-45 µg/ml for Vismodegib respectively as observed from the linearity curves. The regression equations for Vismodegib were found to be y = 21731x + 2304.1 (R2 = 0.999) respectively. The retention time of Vismodegib was found to be 2.871 min. %RSD of the Vismodegib was found to be 0.6. %Recovery was obtained as 99.73% for Vismodegib. LOD and LOQ values obtained from regression equations of Vismodegib were 0.01, 0.03.