Comparison of Zn Content in Rapid-acting Insulin and Biphasic Suspension by FAAS

Sofia Shkunnikova,Jasna Jablan,Tea Širac,Ankica Kulišić,Katarina Lalić

doi:10.5562/cca3830

Sofia Shkunnikova, Jasna Jablan + Show 3 more

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https://doi.org/10.5562/cca3830

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Abstract

Comparison of Zn Content in Rapid-acting Insulin and Biphasic Suspension by FAAS

Highlights

D IABETES mellitus (DM) is one of the most common chronic endocrine diseases, characterized primarily by a lack of or resistance to insulin, which is involved in glucose metabolism, and remains one of the leading causes of death worldwide.[1,2,3] Depending on the underlying pathological process, the disease is divided into two main types
In order to determine the zinc content in different insulin preparations (RAI and intermediate-acting NovoMix® FlexPen® (IAI)), the flame atomic absorption spectrometry (FAAS) method used was validated according to International Council for Harmonization (ICH)[33]
Typical validation characteristics that should be considered according to this guideline include the following parameters: Linearity, limit of detection (LOD) and limit of quantification (LOQ), trueness and precision

Summary

Introduction

D IABETES mellitus (DM) is one of the most common chronic endocrine diseases, characterized primarily by a lack of or resistance to insulin, which is involved in glucose metabolism, and remains one of the leading causes of death worldwide.[1,2,3] Depending on the underlying pathological process, the disease is divided into two main types. Type 1 diabetes, often referred to as juvenile DM, is characterized by the presence of autoantibodies to insulin and to the surface markers of the pancreatic islets, to the β-cells where insulin synthesis occurs. Type 2 diabetes is characterized by the inability of insulin to regulate the entry of glucose into cells, referred to as insulin resistance.[4,5] Human insulin, a polypeptide composed of 51 aminoacids, is the main drug used to treat DM in humans, discovered 100 years ago in Toronto 1921 by Banting, Best and Macleo. In the presence of zinc ions, three dimers associate to form a hexamer in which two zinc ions form a coordination bond with the imidazole group of the B10 histidine residues, the one from each dimer.[6]

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