Selective stability-indicating high-performance liquid chromatographic assay for recombinant human regular insulin.
This report presents a selective HPLC assay capable of separating recombinant human regular insulin from insulin decomposition and transformation products. The assay utilizes an isocratic delivery of mobile phase, a C18 peptide column, UV detection and is performed at ambient temperature. The standard curve ranges from 0.2 to 2.5 U/ml. The inter-day and intra-day variabilities are less than 7 and 5%, respectively, at the concentrations studied. The accuracy and precision are within 5% over the range of the standard curve.
Hoyer
G L
GL
Department of Pharmacy Practice, College of Pharmacy, University of Arizona, Tucson 85721, USA.
Nolan
P E
PE
LeDoux
J H
JH
Moore
L A
LA
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006801:Humans; D007328:Insulin / Q000032:analysis*; D011994:Recombinant Proteins / Q000032:analysis; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet
D007328:Insulin; D011994:Recombinant Proteins