Abstract

Asenapine maleate is a second-generation atypical antipsychotic agent used in the treatment of schizophrenia, a neuropsychiatric disorder. It is available as a fast-dissolving sublingual tablet to avoid extensive first-pass metabolism with higher bioavailability as compared to oral formulations. Although, the established therapeutic solutions do not sufficiently satisfy the patient's safety and efficacy needs. Thus, the core research emphasis is to investigate strategies to produce novel formulations with enhanced safety and efficacy. This necessitates the development of robust, precise, and accurate methods for quantification of asenapine maleate in different sample matrices. Given the foregoing information, the current analysis concentrates on the different analytical techniques used to assess asenapine maleate in bulk, pharmaceutical formulations, and biological specimens. Reverse-phase HPLC coupled with UV detection is a majorly (nearly 50% of papers investigated) used technique for the estimation of asenapine maleate in formulations. On the other hand, for its quantification in the biological matrix, hyphenated techniques using mass spectrometry are widely used. This critical review reveals different analytical methodologies, including spectrophotometric, chromatographic, capillary electrophoresis techniques reported from 2011 to 2020, for the measurement of asenapine maleate in various sample matrices. The information presented in this review would be useful in future research for robust analytical method development for asenapine maleate utilizing a more scientific and risk-based approach. Also, it would aid to minimize analytical failure as well as method fine-tuning throughout the product life cycle. Further, this review may also direct scientists toward the development of methodologies for green research.

摘要

马来酸阿塞那平是第二代非典型抗精神病药，用于治疗精神分裂症，一种神经精神疾病。它可作为快速溶解的舌下片剂使用，以避免广泛的首过代谢，与口服制剂相比具有更高的生物利用度。虽然，现有的治疗方案并不能充分满足患者的安全性和有效性需求。因此，核心研究重点是研究生产具有更高安全性和有效性的新型制剂的策略。这需要开发稳健、精确和准确的方法来量化不同样品基质中的马来酸阿塞那平。鉴于上述信息，目前的分析集中在用于批量评估马来酸阿塞那平的不同分析技术上，药物制剂和生物标本。反相 HPLC 与 UV 检测相结合是一种主要（近 50% 的研究论文）用于评估制剂中马来酸阿塞那平的技术。另一方面，对于其在生物基质中的量化，使用质谱的联用技术被广泛使用。这篇批判性评论揭示了不同的分析方法，包括 2011 年至 2020 年报道的分光光度法、色谱法、毛细管电泳技术，用于测量各种样品基质中的马来酸阿塞那平。本综述中提供的信息将有助于未来的研究，利用更科学和基于风险的方法开发马来酸阿塞那平的稳健分析方法。还，这将有助于在整个产品生命周期中最大限度地减少分析失败以及方法微调。此外，本综述还可能指导科学家开发绿色研究方法。