Validation of cinmetahaemoglobin technique in the determination of haemoglobin at dehidrated trofín®

Abstract

The Trofín® in dehydrated form is an active pharmaceutical ingredient which contains bovine blood that is used to elaborate different nutritional supplements in tablets. In this formulation bovine hemoglobin (Hb) is the protein of major interest because it brings heme iron (Fe), compound by which exert its antianemic effect. The objective of this work consisted in to validate the cianmethahaemoglobin technique (CHM) for quantification the Hb that contains the dehydrated Trofín® with the aim of to elaborate a reference material for the quality control of the industrial batches of Trofín® and the tablets. The specificity of the method was demonstrated because the components of the placebo do not interfering with the quantification of Hb in the dehydrated, because it haven´t presence of bovine blood The linearity was studied using a certificated CMH as a standard, preparing a curve of concentrations between 9,3 mg/100 to 56,2 mg/100 mL, thus like, in the suspension of dehydrated Trofín® as a concentration between 10 g to 30 g/100 mL, demonstrating that in both cases the r2≥ 0,98. It was established the linearity, precision and accuracy of the method in the bovine Hb concentration range of (30,80 y 101,12 g/L). The precision of the method was demonstrated with the repeatability, intermediate precision and reproducibility presented a CV ≤ 5 %.Accuracy was demonstrated because was not obtained differences between the concentration of added Hb at dehydrated Trofín® and the calculated concentration for (p > 0,05) and was obtaining a recover of 100%.