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.

基于生物技术的活性药物成分（例如 GLP-1 类似物）的开发带来了 2 型糖尿病治疗方案的变化。为了获得更好的治疗效果，这些活性药物成分需要适当的给药，而不会产生不良反应或毒性。因此，需要开发多种GLP-1类似物产品的定量方法，以实现治疗目标，其中ELISA和HPLC就应运而生。这些方法的开发、优化和验证是为了确定 GLP-1 类似物，不仅在活性药物成分的最终配方中，而且在临床前和临床试验评估期间。本综述强调了在 GLP-1 类似物（尤其是艾塞那肽）评估过程中使用的 ELISA 和 HPLC 方法的作用。