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Review
. 2019 Jun;9(3):143-155.
doi: 10.1016/j.jpha.2019.02.001. Epub 2019 Feb 26.

Comparison of ELISA and HPLC-MS methods for the determination of exenatide in biological and biotechnology-based formulation matrices

A R Pinho  1 , A Fortuna  2   3 , A Falcão  2   3 , A C Santos  1   4 , R Seiça  5 , C Estevens  6 , F Veiga  1   4 , A J Ribeiro  1   7
Affiliations
Review

Comparison of ELISA and HPLC-MS methods for the determination of exenatide in biological and biotechnology-based formulation matrices

A R Pinho et al. J Pharm Anal. 2019 Jun.

Abstract

The development of biotechnology-based active pharmaceutical ingredients, such as GLP-1 analogs, brought changes in type 2 diabetes treatment options. For better therapeutic efficiency, these active pharmaceutical ingredients require appropriate administration, without the development of adverse effects or toxicity. Therefore, it is required to develop several quantification methods for GLP-1 analogs products, in order to achieve the therapeutic goals, among which ELISA and HPLC arise. These methods are developed, optimized and validated in order to determine GLP-1 analogs, not only in final formulation of the active pharmaceutical ingredient, but also during preclinical and clinical trials assessment. This review highlights the role of ELISA and HPLC methods that have been used during the assessment for GLP-1 analogs, especially for exenatide.

Keywords: ELISA; Exenatide; HPLC; Therapeutic drug monitoring; Type 2 diabetes.

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Figures

Image 1
Graphical abstract
Fig. 1
Fig. 1
Exenatide's pathway since its administration to its quantification by high performance liquid chromatography or enzyme-linked immunosorbent assay, comprising the main pretreatment procedures applied to samples before each bioanalytical methodology.
See this image and copyright information in PMC

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