Stability indicating RP-HPLC method development and validation for quantification of impurities in gonadotropin-releasing hormone (Elagolix): Robustness study by quality by design.

Autor: Bandaru LGR; Department of Chemistry, GITAM School of Science, GITAM Deemed to be University, Hyderabad, Telanga, India., Kanuparthy PR; Department of Chemistry, GITAM School of Science, GITAM Deemed to be University, Hyderabad, Telanga, India., Jeedimalla N; Laurus Generics, Inc., Berkeley, New Jersey, USA., Nayak BV; Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM Deemed to be University, Hyderabad, Telangana, India., Raghupathi JK; Department of Food Science, Purdue University, West Lafayette, Indiana, USA., Katari NK; School of Chemistry & Physics, College of Agriculture, Engineering & Science, Westville Campus, University of KwaZulu-Natal, Durban, South Africa., Gundla R; Department of Chemistry, GITAM School of Science, GITAM Deemed to be University, Hyderabad, Telanga, India.

Publikováno v: Biomedical chromatography : BMC [Biomed Chromatogr] 2024 Dec; Vol. 38 (12), pp. e6036. Date of Electronic Publication: 2024 Nov 01.