HPLC和PDA稳定性指示方法开发与验证综述

Chilukuri Revathi Sreelekha, N. Sahoo
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引用次数: 0

摘要

本文综述了与HPLC技术发展有关的安全性评价方法和关注问题。高效液相色谱法是评价药物项目稳定性的重要分析手段。高效液相色谱技术必须具有分离、检测和评价在合成过程中可能出现的大量药物相关杂质的能力。它进一步理解药物化合物和药物项目的化学性质,并且还协助开发表明逻辑方法的稳定性。一些关键的色谱变量进行评估,以优化检测所有可能相关的退化。这项技术是否能从污染物中分辨出主要的药物元素,还有待仔细检验。新的化学实体和药物项目应进行强制销毁研究,这将有助于发展和证明这种安全指示技术的独特性。在药物生长的每个阶段都提出了有用的建议,这肯定有助于避免失败。所提出的高效液相色谱技术被发现是直接和信誉良好的定期同步分析扑热息痛硫胺素和吡哆醛磷酸在片剂的电脑配方。总分裂的分析师在恶化产品的可见性表明选择性的方法。
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A Review on Stability Indicating Method Development and Validation using HPLC and PDA
This short article reviews approaches as well as concerns pertinent to an evaluation on Security suggesting HPLC technique development. High Performance Fluid Chromatography (HPLC) is a vital analytical device in assessing medication item stability. HPLC techniques must have the ability to divide, detect and evaluate the numerous drug-related impurities that may be presented throughout synthesis. It further understands the chemistry of the drug compound and drug item and also assists in the development of stability suggesting logical methodology. A number of crucial chromatographic variables were evaluated in order to optimize the detection of all possibly relevant degrades. The technique ought to be meticulously checked out for its capability to distinguish the primary drug elements from the pollutants. New chemical entities as well as drug items should go through forced destruction research studies which would be helpful in developing as well as demonstrating the uniqueness of such security indicating techniques. At every stage of drug growth useful recommendations are offered which will certainly aid to stay clear of failures. The proposed HPLC technique was discovered to be straightforward and reputable for the regular synchronised analysis of paracetamol thiamine as well as pyridoxal phosphate in tablet computer formulations. Total splitting up of analysts in the visibility of deterioration products indicated selectivity of the approach.
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