ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ETELCALCETIDE IN BULK AND ITS DOSAGE FORM USING RP-HPLC

A simple and precise RP-HPLC method was developed for the estimation of the Etecalcetide. Initially, various mobile phase compositions were tried to separate title ingredients. Mobile phase and flow rate selection was based on peak parameters (height, tailing, theoretical plates capacity or symmetry factor) run time and resolution. Finally The mobile phase containing mixture of 50% OPA buffer 50% methanol with the flow rate of 1.0 ml/ min. The optimum wavelength for detection was 235nm at which better detector response for drug was obtained. The Retention time for Etelcalcetide was found to be 4.653min respectively. To ascertain its effectiveness, system suitability test were carried out on fresh prepared stock solutions. The regression 0.999 respectively. The low value of % R.S.D indicate the method is precise and accurate.