Forced Degradation Studies of Elagolix Sodium With the Implementation of High Resolution LC-UV-PDA-MSn (N=1,2, 3…) and NMR Structural Elucidation

Zhong, Xueni; Lv, Qianqian; Yong, Qiyun; Hu, Wenping; Li, Dan; Ji, Shuhui; Zhan, Liuyue; Chen, Wenbin; Li, Min; Lin, Jianwei; Sun, Cuirong

doi:10.2139/ssrn.4252205

SSRN Journal

2022

DOI: 10.2139/ssrn.4252205

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Forced Degradation Studies of Elagolix Sodium With the Implementation of High Resolution LC-UV-PDA-MSn (N=1,2, 3…) and NMR Structural Elucidation

Xueni Zhong

Qianqian Lv²,

Qiyun Yong³

et al.

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2024

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

Bandaru,

Kanuparthy,

Jeedimalla

et al. 2024

Biomedical Chromatography

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The purpose of this research was to establish and validate a reverse phase HPLC method for the determination of Elagolix impurities in pharmaceutical dosage form. Mobile phase A, consisting of 10 mM sodium dihydrogen phosphate (pH 6.0) and acetonitrile in a 95:5 v/v ratio, and mobile phase B, containing 85:10:5 v/v/v of acetonitrile, Milli‐Q water, and methanol, were used to achieve the method's specificity in the analytical column Kromasil 100‐C18 (250 mm × 4.6 mm, 5 μm). The gradient program includes (%B/Time [min]: 36/0, 36/10, 38/15, 85/55, 85/65, 36/67, and 36/75). The flow rate is 0.8 mL/min. The overall run duration is 75.0 min, the injection volume is 10.0 μL, and the detection is at 210 nm in UV. The samples were subjected to hydrolysis, oxidation, and heat conditions in order to facilitate their forced degradation. The procedure was validated and determined with the standards of ICH guidelines. From the LOQ to a concentration level of 200%, the linearity of the technique was ascertained. An accuracy range of LOQ to 150% was established for the method, and the average recovery was acceptable. Design of experiments, part of the quality by design idea, was used to prove the method's reliability.

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

Bandaru,

Kanuparthy,

Jeedimalla

et al. 2024

Biomedical Chromatography

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show abstract

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Forced Degradation Studies of Elagolix Sodium With the Implementation of High Resolution LC-UV-PDA-MSn (N=1,2, 3…) and NMR Structural Elucidation

Cited by 1 publication

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

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

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