DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF RELUGOLIX IN API FORM AND MARKETED PHARMACEUTICAL DOSAGE FORM

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Syed Hafeez Ahmed, Mohammed Zakaria Ansar, Zainab Sultana, Nuzhath Faheema, Nausheennaz Bashirjani Sayed

Abstract: A new, simple, rapid, precise, accurate and reproducible RP-HPLC method for estimation of Relugolix in bulk form and marketed formulation. Separation of Relugolix was successfully achieved on a Symmetry ODS C18 (4.6 x 250mm, 5mm) column in an isocratic mode of separation utilizing Acetonitrile: Methanol in the ratio of 80:20% v/v at a flow rate of 1.0 mL/min and the detection was carried out at 272nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 10-50mcg/mL for Relugolix. The correlation coefficient was found to be 0.999 for Relugolix. The LOD and LOQ for Relugolix were found to be 1.1µg/mL and 3.2µg/mL respectively. The proposed method was found to be good percentage recovery for Relugolix, which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard solution with the sample solution. Therefore, the proposed method specifically determines the analyte in the sample without interference from excipients of pharmaceutical dosage forms.

Relugolix, RP-HPLC, Accuracy, Precision, Robustness, ICH Guidelines.