Abstract

HERRERA C, Jholeisa C; PATO L, Tatiana L; PEREZ M, Dunia M  and  IBARZ H, María T. Uncertainty estimation for the USP34 NF29 2011 analysis of potency Recombinant DNA Isophane Human Insulin from PR-HPLC. INHRR [online]. 2013, vol.44, n.2, pp.21-26. ISSN 0798-0477.

The purpose of measurement is to determine the value of a quantity, called the measurand. The natural imperfection of determining measurements, makes impossible to know with absolute certainty the true value of a magnitude, since all measurement implies an uncertainty, which is a non-negative parameter that characterize the dispersion of the values attributed to a measurand. In this research, we employed a different strategy to the "bottom-up" procedure, proposed by the ISO, which allowed us to calculate globally the uncertainty, by grouping values, determined during the verification of the analytical method. The obtained value in our study was 3.46 IU/mL with 90% confidence. The matrix effect of the drug, depending on the insulin type present inside, was observed as the bigger contribution source to the calculation, as well as the accuracy and traceability of the reference pattern, which contribute in the final uncertainty similarly. Thus, our efforts should be directed to the optimization of the homogenization processes and the acquisition of the primary type reference pattern, in order to ensure over time, reproducible, traceable and reliable results.

Keywords : biotechnological products; insulin; formulation; specification; acceptance range; high resolution liquid chromatography; certified reference material; variability; uncertainty; traceability.