Bioanalytical Method For Development, Validation and Sensitive Quantification of Elagolix Sodium Using RP – HPLC Method

Abstract

Background: Nearly 190 million women worldwide suffer with endometriosis, a chronic gynaecological disorder that is dependent on estrogen and causes pain, infertility, and a decline in quality of life. Elagolix sodium is a gonadotropin-releasing hormone (GnRH) antagonist that suppresses gonadotropins quickly, making it a promising therapeutic treatment.

Objective: Finding specifics about absorption, distribution, metabolism and excretion (ADME) profiles in the context of female Sprague–Dawley (SD) rats is critical to translational research and therapeutic optimization, which necessitates further steroid pharmacokinetic profile studies utilizing preclinical models.

Method: Sensitive quantification of drug levels in plasma is paramount for defining exposure–response relationships and optimal efficacy. In the present work, a RP-HPLC bioanalytical method for quantification of elagolix sodium plasma samples has been developed and validated.

Result: Validation was carried out as per ICH M10 and FDA guidelines to the linear range (R² = 0.998); LLOQ (103.4=ng/mL), HQC (4300=ng/mL), intraday accuracy range from 98.16% to 103.32% & precision varies from 0.51% to 5.26% and interday accuracy range from 97.41% to 105.06% & precision falling between 0.64% to 5.64%, recovery for elagolix sodium varied from 47.73% to 59.33%.

Conclusion: For large preliminary sample cohorts, this RP HPLC approach provides an economical and reliable substitute for LC MS/MS by combining simplicity with international standards. This validated method enables the translational research in therapeutic endometriosis, facilitates optimizing doses to achieve the desired effect and signals the importance of readily available analytical platforms for the advancement of women's health worldwide