Abstract
ABT-861 is a gonadotropin releasing hormone (GnRH) antagonist candidate drug synthesized at Abbott Laboratories for use in medical conditions responsive to hormonal manipulation (e.g., prostate cancer in elderly males, endometriosis in females, and central precocious puberty in children). A high-performan ce liquid chromatography (HPLC) method employing gradient elution with ultraviolet (UV) detection is developed for the assay of ABT-861 and determination of impurities in the bulk powder and injectable formulations. The chromatographic conditions employed in this work include the use of a 250 × 4.6 mm, 5-µm ODS Vydac HPLC column at 35°C, an acetonitrile-water (0.1 % TFA in each phase, v/v) eluent, and a 60-min run time using UV detection. The chromatographic conditions are used for the determination of ABT-861 and its degradation products and manufacturing impurities in the bulk powder and injectable formulations. The limit of detection is found to be approximately 9 ng at 225 nm. Method validation includes linearity of detector response with amount injected, precision, and standard addition-recovery data. Under the chromatographic conditions employed, diastereomeric and manufacturing impurities and degradation products are separated from ABT-861, demonstrating that the method is stability-indicating. Thus, the current method is seen to be suitable for the routine analysis of ABT-861 and related impurities, providing good selectivity and sensitivity.
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