Abstract

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

Shreya Sutariya* and Dr. Priyanka Yadav

ABSTRACT

A novel, simple, selective, and accurate Stability-Indicating RP-HPLC Method for the Estimation of Relugolix in Tablet Dosage Form A reliable and precise reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantification of Relugolix in tablet form. Chromatographi separation was achieved using an Inertsil ODS-3 column (150 mm × 4.6 mm, 5 µm) as the stationary phase. The mobile phase consisted of a buffer and acetonitrile in a 70:30 (v/v) ratio, with a flow rate of 1.0 mL/min. The detection wavelength was set at 220 nm, and the column temperature was maintained at 25°C. The retention time of Relugolix was observed at approximately 4.775 minutes. The method was validated per ICH guidelines, assessing key analytical parameters such as specificity, linearity, precision, accuracy, limit of detection (LOD), limit of quantification (LOQ), and robustness. Linearity was established within the concentration range of 30–90 μg/mL, with a recovery rate ranging from 99.2% to 100.6%. The developed RP-HPLC method demonstrated excellent specificity, accuracy, precision, and robustness, making it well-suited for routine quality control analysis of Tablet Dosage form.

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