Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology (CHARUSAT), Anand, Gujarat, India.
Crit Rev Anal Chem. 2022;52(8):1755-1771. doi: 10.1080/10408347.2021.1919858. Epub 2021 Jun 1.
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.
马来酸阿散平是一种用于治疗精神分裂症等神经精神疾病的第二代非典型抗精神病药物。它有速溶舌下片剂型，可避免广泛的首过代谢，生物利用度高于口服制剂。尽管如此，现有的治疗方法并不能充分满足患者的安全性和疗效需求。因此，核心研究重点是研究生产具有更高安全性和疗效的新型制剂的策略。这就需要开发强大、精确和准确的方法来定量不同样品基质中的马来酸阿散平。鉴于上述信息，目前的分析集中在用于评估批量、药物制剂和生物样本中马来酸阿散平的不同分析技术上。反相高效液相色谱法（RP-HPLC）结合紫外检测是主要（近 50%的研究论文）用于评估制剂中马来酸阿散平的技术。另一方面，对于其在生物基质中的定量，使用质谱的联用技术被广泛使用。本综述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、色谱法和毛细管电泳技术，用于测量各种样品基质中的马来酸阿散平。本综述中提供的信息将有助于未来利用更科学和基于风险的方法开发马来酸阿散平的稳健分析方法的研究。此外，它还有助于在整个产品生命周期中减少分析失败和方法微调。此外，本综述还可能引导科学家开发绿色研究方法。
