紫外可见光谱法和高效液相色谱法用于药物分析的仪器及验证方法综述

D. Singh, V. Chauhan, Sapna Chaudhar, Anupama Kaushik
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引用次数: 0

摘要

本分析的目的是确定高效液相色谱和紫外/可见光谱的应用。紫外可见光谱学是在分析中用于测试各种类型的溶剂和物质的术语。特别是,小型企业通常更喜欢光谱学,因为设备成本较低,维护问题有限。该分析方法是基于计算无色化合物(200 ~ 400nm)对光谱近紫外方向单色光的吸收。药物分析需要必要的程序来确定这些化合物的“特性、强度、一致性和纯度”。药品生产过程中原料和中间体的分析也包括在内。众所周知,解离常数是新化合物生产和优化过程中最关键的参数,对配方的成功开发至关重要。对联立方程法、差示分光光度法、高效液相色谱法和流体可见紫外分光光度法进行了测定。高效液相色谱法是一种有效的药品评价分析方法。HPLC方法应该能够分离、检测和定量不同的药物和药物相关降解物,这些降解物可以形成、检测和定量合成过程中可能添加的任何药物和药物相关杂质。验证是确定方法的性能特征和局限性,并定义改变这些特征和改变程度的因素的过程。
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A REVIEW ON INSTRUMENTATION AND VALIDATION METHOD OF UV-VISIBLE SPECTROSCOPY AND HPLC FOR THE ANALYSIS OF DRUGS
The purpose of the present analysis was to identify the application of HPLC and UV/Vis spectroscopy. UV-VIS Spectroscopy is the term used to test the various types of solvents and substances in an analysis. In particular, small-scale enterprises typically prefer spectroscopy, as the cost of equipment is lower and maintenance issues are limited. The analysis approach is based on the calculation of the absorption of monochromatic light in the near ultraviolet direction of a spectrum by colourless compounds (200 400nm). The pharmaceutical analysis requires the necessary procedure for the determination of the "identity, intensity, consistency and purity of such compounds. Analysis of raw materials and intermediates during the drug manufacturing process is also included. The dissociation constant is well known to be the most critical parameter in the production and optimization of a new compound for successful development of formulations. Information on the system of simultaneous equation, difference spectrophotometry, high-performance liquid chromatography (HPLC) or fluid visible ultraviolet spectrophotometry was measured. High performance liquid chromatography (HPLC) is an effective analytical method for drug product evaluation. Methods of HPLC should be able to isolate, detect and quantify the different drugs and drug related degradants that can shape, detect and quantify any drugs and drug related impurities that can be added during synthesis. Validation is the process of determining a method's performance features and limitations and defining the factors that which alter these characteristics and to what extent.
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