Abstract
A rapid and sensitive HPLC method was developed and validated for selective determination of the human growth hormone (hGH) somatropin in the presence of its deamidated and oxidized degradation products. Reversed-phase chromatography with an acetonitrile and ammonium bicarbonate mobile phase in gradient elution mode was used. A short run time of 15 min allowed rapid and cost-effective analysis, with an average retention time of 7.4 min for native hGH, 6.2 min for its deamidated form, and 4.3 and 6 min for its oxidized variants. The method was validated for selectivity, linearity, and intra- and interday variations according to International Conference on Harmonization guidelines. The proposed method was successfully applied for rapid evaluation of the quantity of hGH during downstream processing, formulation, and storage.
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