阿普唑仑原料药和药用剂型的分析开发与验证综述

Gaurav M. Prajapati, Devang R. Ghuge
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引用次数: 0

摘要

阿普唑仑于2003年获得美国FDA批准。阿普唑仑有缓释片、口溶片(在口中迅速溶解的片剂)和浓缩溶液(液体)三种剂型。对于治疗严重的焦虑和恐慌症,阿普唑仑是最常用的苯二氮卓类药物之一。阿普唑仑的IPUAC名称为8-氯-1-甲基-6-苯基- 4h -[1,2,4]三唑[4,3-a][1,4]苯二氮卓。分子式为C17H12ClFN4,分子量为326.75 g/mol。这些文章可以作为阿普唑仑的概述,包括其药物概况、药理学、药代动力学和分析HPLC程序,这些程序通常用于确定常见的供应问题。这些综述涵盖了流动相、流动相比、色谱柱、保留时间、流速、紫外检测器波长、运行时间等主题。线性度、回收率、检出限、定量限均为验证参数。药物分析作为纯剂型和药物剂型的内部控制,对质量保证至关重要。分析方法的发展已成为一项至关重要的研究活动。
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A Comprehensive Review of the Analytical Development and Validation of Alprazolam in Bulk and Pharmaceutical Dosage Form
Alprazolam is approved in 2003 by US FDA. Alprazolam is available as an extended-release tablet, a mouth dissolving tablet (a tablet that dissolves rapidly in the mouth), as well as a concentrated solution (liquid). For the treatment of severe anxiety and panic disorder, alprazolam is one of the most commonly prescribed benzodiazepines. IPUAC name of Alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-[1,2,4]triazolo[4,3-a] [1, 4] benzodiazepine. The molecular formula and molecular Weight is C17H12ClFN4 and 326.75 g/mol. These articles may serve as an overview of Alprazolam with their drug profile, pharmacology, pharmacokinetics, and analytical HPLC procedures that are commonly employed in determining common provision issues. These reviews cover topics such as mobile phase, mobile phase ratio, column, retention time, flow rate, UV detector wavelength, run time, and more. Linearity, percent recovery, detection limit, and quantification limit are all validating parameters. The pharmaceutical analysis serves as an internal control for pure and pharmaceutical dosage forms, which is critical for quality assurance. The development of analytical methods has emerged as a crucial study activity.
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