Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF SELPERCATINIB BULK AND PHARMACEUTICAL DOSAGE FORM

Miss. Gomati S. Bhole*, Mrs. Sandhya S. Ahire, Miss. Varsha Singh, Miss. Swati G. Patil

ABSTRACT

Analytical monitoring of the pharmaceutical products, or of specific ingredients within the product, its necessary to insure it’s safely and efficacy throughout all phases of its shelf-life, including storage, distribution and use. Essentially, the techniques of chromatography is based on the differences in the rate at which the components of the mixture move through a porous medium (called stationary phase) under the influence of same solvent or gas (called mobile phase). For the RP - Agilent Tech. Gradient System with Auto injector, UV (DAD) &Gradient Detector Reverse Phase (Agilent) C18 column (4.6mm x 250mm; 5µm), a 20µl injection loop and UV730D Absorbance detector and running Chemstation Software. Methanol: water (0.1% formic acid) (40.7:59.3v/v) pH 3 Was used as the mobile phase for the method. The detection wavelength was 224 nm and flow rate was 0.76ml/min. In the developed method, the retention time of Selpercatinib were found to be be 4.122 min respectively The developed method was validated according to the ICH guidelines. The linearity, precision, range, robustness was within the limits as specified by the ICH guidelines. Hence the method was found to be simple, accurate, precise, economic and reproducible. The method has been found to be better than previously reported method, because of its less retention time, isocratic mode and use of an economical and readily available mobile phase, readily available column, UV detection and better resolution of peaks.

Keywords: RP-HPLC; Analytical Chemistry, linearity, precision, ICH guidelines, Selpercatinib.