Priya M. Dandekar, Mayuri G. Zore, Aasma I. Sheikh, Abhishek S. Jaware, Aditya G. Sarnaik, Aditya A. Sawde, Achal B, Lode
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引用次数: 0
Abstract
High-performance liquid chromatography (HPLC) is an important qualitative and quantitative technique, generally used for the estimation of pharmaceutical and biological samples. It is the most versatile, safest, dependable, and fastest chromatographic technique for the quality control of drug components. This article was prepared with a review different aspects of HPLC, such as principle types, instrumentation, and application. High- Performance Liquid Chromatography has played a significant role in clinical laboratories for the separation and quantitation of biomarkers in different body fluids. The development of HPLC involves four basic steps; scouting, optimization, robustness testing, and validation. The technique is used to analyze drugs and medicines for their purity and to maintain the highest standards for pharmaceutical products with the end goal of helping patients with medical issues. Method of validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Validation High-Performance Liquid Chromatography method as per ICH guidelines covers all the performance characteristics of validation, like Accuracy, precision, specificity, linearity, range, limit of detection, limit of quantification, robustness, system suitability the testing. The limitation of High-Performance Liquid Chromatography methods of development, public health importance, and validation is the automated process becomes complicated, has low separation power, and is expensive but High-Performance Liquid Chromatography is the modern diagnostic technique is used in all sectors
高效液相色谱法(HPLC)是一种重要的定性和定量技术,通常用于药品和生物样品的估算。它是用于药物成分质量控制的最通用、最安全、最可靠和最快速的色谱技术。本文对高效液相色谱的不同方面进行了综述,如原理类型、仪器和应用。高效液相色谱在临床实验室分离和定量不同体液中的生物标记物方面发挥了重要作用。高效液相色谱的开发包括四个基本步骤:探索、优化、稳健性测试和验证。该技术用于分析药物和药品的纯度,并保持医药产品的最高标准,最终目的是帮助患者解决医疗问题。方法验证是用于确认特定测试所采用的分析程序是否适合其预期用途的过程。根据 ICH 指南,高效液相色谱法的验证涵盖了验证的所有性能特征,如准确性、精确性、特异性、线性、范围、检测限、定量限、稳健性、系统适用性等。高效液相色谱法在开发、公共卫生重要性和验证方面的局限性在于自动化过程变得复杂、分离能力低、价格昂贵,但高效液相色谱法是现代诊断技术,已被广泛应用于各行各业。