Poster (Scientific congresses and symposiums)
Micellar electrokinetic chromatography against the counterfeiting of insulin formulations
Lamalle, Caroline; Servais, Anne-Catherine; Crommen, Jacques et al.
201410th International Symposium on Drug Analysis 25th International Symposium on Pharmaceutical and Biomedical Analysis
 

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Abstract :
[en] Insulin plays an important role in the homeostasis of blood glucose concentration. A deficiency of this hormone causes diabetes, which can be treated by subcutaneous injection of synthetic insulin. Besides human regular insulin, several modified analogues have been developed to accelerate (Lispro, Aspart, Glulisin) or delay (Glargin, Detemir) its absorption. Moreover, protamine is sometimes associated with human, Lispro or Aspart insulin to give a crystalline form, which delays the action of insulin, providing it with a prolonged absorption profile after injection. Diabetes is one of the most common metabolic diseases in the world; its prevalence increases continuously. A lot of patients are therefore concerned with the treatment, which is relatively expensive and requires a prescription. Some pharmaceutical formulations can sometimes be found without prescription on the parallel market but the risk of drug counterfeiting is then considerably increased. The poor quality of these drugs can lead to harmful consequences for the public health. It is therefore essential to develop a suitable method for the identification and quantification of human insulin and its analogues inside formulations. Ortner et al. [1] have already proposed micellar electrokinetic chromatography (MEKC) methods to detect simultaneously human insulin and its five analogues but no quantitative applications were presented. Furthermore, formulations containing protamine were not tested so we included them in our study. The first optimisation step involved the sample preparation procedure. An acidic sample solution (10 mM HCl) was finally selected to solubilise protamine and Glargin. Then the background electrolyte composition was investigated to separate the components present in the formulations. A basic buffer (50 mM ammonium acetate pH 9) was selected, providing an important and stable electroosmotic flow, a negative charge to the insulins and avoiding any adsorption to the capillary wall. The addition of sodium dodecylsulfate (SDS) and acetonitrile (ACN) was also found crucial for selectivity. With 50 mM SDS and 15% ACN the six insulins and the two major excipients (phenol and meta-cresol) were fully separated within 15 minutes. This method was then entirely validated for the human insulin and the quality control of related formulations was performed. The next step will be the validation and the quantification of the other analogues.
Research center :
Centre Interfacultaire de Recherche du Médicament - CIRM
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Lamalle, Caroline ;  Université de Liège > Département de pharmacie > Analyse des médicaments
Servais, Anne-Catherine  ;  Université de Liège > Département de pharmacie > Analyse des médicaments
Crommen, Jacques ;  Université de Liège > Département de pharmacie > Département de pharmacie
Fillet, Marianne ;  Université de Liège > Département de pharmacie > Analyse des médicaments
Language :
English
Title :
Micellar electrokinetic chromatography against the counterfeiting of insulin formulations
Publication date :
2014
Event name :
10th International Symposium on Drug Analysis 25th International Symposium on Pharmaceutical and Biomedical Analysis
Event date :
du 22 au 25 juin 2014
Audience :
International
Available on ORBi :
since 05 May 2015

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