Abstract
A rapid and sensitive HPLC method was developedand validated for selective determination of thehuman growth hormone (hGH) somatropin in thepresence of its deamidated and oxidized degradationproducts. Reversed-phase chromatographywith an acetonitrile and ammonium bicarbonatemobile phase in gradient elution mode was used.A short run time of 15 min allowed rapid andcost-effective analysis, with an average retentiontime of 7.4 min for native hGH, 6.2 min for itsdeamidated form, and 4.3 and 6 min for its oxidizedvariants. The method was validated for selectivity,linearity, and intra- and interday variations accordingto International Conference on Harmonizationguidelines. The proposed method was successfullyapplied for rapid evaluation of the quantity ofhGH during downstream processing, formulation,and storage.
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