Selective Determination of Human Growth Hormone (Somatropin) in the Presence of Its Chemical Degradation Products

J AOAC Int. 2017 Jul 1;100(4):1023-1028. doi: 10.5740/jaoacint.16-0194.

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.

Publication types

  • Validation Study

MeSH terms

  • Chromatography, High Pressure Liquid*
  • Chromatography, Reverse-Phase*
  • Human Growth Hormone / analysis*
  • Humans
  • Oxidation-Reduction

Substances

  • Human Growth Hormone