A review on specific and sensitive analytical method development and validation

International Journal of Pharmaceutical Chemistry and Analysis Pub Date : 2023-04-15 DOI:10.18231/j.ijpca.2023.005

MD Nazmus Sakib Chowdhury

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Abstract

A specific and sensitive analytical method development and validation plays an important role for building drug discovery, product development and manufacturing of pharmaceuticals. The main purpose of this review article is to check the report of specific and sensitive analytical method development and validation parameters involved in different pharmaceuticals manufacturing. Development of sensitive analytical method is extremely much significant because it ensures product efficacy and product quality. The sensitive analytical method development and validation is the process of proving that the analytical method meets the analytical acceptance criteria and it can use to measure the concentration of target molecule at its specification limit. The aim of method development is to produce a reproducible specific and sensitive analytical method in a cost effective manner. The parameters of validation involved are introduced as specificity, method precision, accuracy, linearity, limit of detection (LOD), limit of quantitation (LOQ), ruggedness, robustness and system precision of the target molecule.

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特异性和敏感性分析方法的开发和验证综述

一种特异、灵敏的分析方法的开发和验证在药物发现、产品开发和生产中起着重要的作用。这篇综述文章的主要目的是检查不同药品生产中涉及的特异性和敏感性分析方法开发和验证参数的报告。灵敏分析方法的发展对保证产品的功效和质量具有十分重要的意义。灵敏分析方法的开发和验证是证明该分析方法符合分析验收标准，并能在其规定限度内测量目标分子的浓度的过程。方法开发的目的是在成本有效的方式下产生可重复的、特异的、敏感的分析方法。所涉及的验证参数包括特异性、方法精密度、准确度、线性度、检出限(LOD)、定量限(LOQ)、坚固性、鲁棒性和系统精度。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Pharmaceutical Chemistry and Analysis

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