RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF RELUGOLIX IN BULK AND TABLET DOSAGE FORM

Pritam S. Jain*, Ashish P. Gorle*, N. G. Haswani, Savita Mandan, Hina Chaudhari, Mayuri Chaudhari

A new simple, precise, accurate, sensitive and rapid chromatographic method based on RP-HPLC was developed and validated for the estimation of Relugolix in bulk and tablet dosage form. Methanol: Water (70:30 v/v)) was used as mobile phase. A isocratic programing has been done, on a reverse phase Qualisil C18, (250 mm× 4.6mm, 5 μm) with rate 0.8 mL/min, monitored at 290 nm. The mean retention times of Relugolix were found to be 4.10 min respectively. Linearity of Relugolix was found to be 2-12 μg/mL, R2= 0.9993 respectively. The developed methods have shown the best findings in terms of linearity, accuracy, precision, LOD and LOQ for API and in tablet. The depicted method can routinely be used for the determination of Relugolix in bulk and tablet formulation.