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 C 18 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.