title: Selective Determination of Human Growth Hormone (Somatropin) in the Presence of Its Chemical Degradation Products.
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.
authors.affiliation: Cairo University, Faculty of Pharmacy, Analytical Chemistry Department, Kasr El-Aini St, 11562 Cairo, Egypt.
authors.forename: Mamdouh R
authors.initials: MR
authors.lastname: Rezk
authors.affiliation: National Organization for Research and Control of Biologicals, 12654 Giza, Egypt.
authors.forename: Marwa F
authors.initials: MF
authors.lastname: Mohamed
authors.affiliation: National Organization for Research and Control of Biologicals, 12654 Giza, Egypt.
authors.forename: Faten Abdelaziz
authors.initials: FA
authors.lastname: Fathalla
authors.affiliation: Cairo University, Faculty of Pharmacy, Analytical Chemistry Department, Kasr El-Aini St, 11562 Cairo, Egypt.
authors.forename: Mostafa A
authors.initials: MA
authors.lastname: Shehata