Dipak Chandrakant Kulkarni¹, Anima Sunil Dadhich¹* and Mukthinuthalapati Mathrusri Annapurna²

¹Department of Chemistry, GITAM School of Science, Visakhapatnam, India
²GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, India

*Corresponding Author: Anima Sunil Dadhich, Department of Chemistry, GITAM School of Science, Visakhapatnam, India.

Received: June 11, 2024; Published: June 26, 2024

Abstract

Elagolix is used for the treatment of endometriosis. A new RP-HPLC method (Gradient mode) has been developed for the estimation of Elagolix API and its four impurities such as Elagolix impurity-1, Elagolix impurity-2, Elagolix impurity-4 and Elagolix impurity-5 using Waters Alliance system with Inertsil C8 analytical column (PDA detector). Chromatographic experiments were performed on a Waters alliance Model HPLC system, and the separation was carried out on an Inertsil and column temperature was 35ºC. A mixture of phosphate buffer solution (pH adjusted to 3.5 with ortho phosphoric acid) and Acetonitrile was used as mobile phase for the chromatographic study (Detection wavelength: 275 nm). The flow rate was 1.0 mL/min and the total run time was 40 min. Stress degradation studies were performed and the method was validated as per ICH guidelines.

Keywords: Elagolix Sodium; RP-HPLC; Impurities; Stability Indicating; Validation; ICH Guidelines

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Citation

Citation: Anima Sunil Dadhich., et al. “Analytical Method Development and Validation for the Evaluation of Elagolix and its Impurities by RP-HPLC".Acta Scientific Pharmaceutical Sciences 8.7 (2024): 123-131.

Copyright

Copyright: © 2024 Anima Sunil Dadhich., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.