2024
DOI: 10.1002/bmc.6036
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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

Lova Gani Raju Bandaru,
Phani Raja Kanuparthy,
Nagalakshmi Jeedimalla
et al.

Abstract: 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/Tim… Show more

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