Selective Determination of Human Growth Hormone (Somatropin) in the Presence of Its Chemical Degradation Products
Author:
Rezk Mamdouh R1,
Mohamed Marwa F2,
Fathalla Faten Abdelaziz2,
Shehata Mostafa A1
Affiliation:
1. Cairo University, Faculty of Pharmacy, Analytical Chemistry Department, Kasr El-Aini St, 11562 Cairo, Egypt
2. National Organization for Research and Control of Biologicals, 12654 Giza, Egypt
Abstract
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.
Publisher
Oxford University Press (OUP)
Subject
Pharmacology,Agronomy and Crop Science,Environmental Chemistry,Food Science,Analytical Chemistry