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A Brief Review of HPLC Analytical Method Validation
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Amir Beheshti Maal   , Seyed Mohammad Alavi , Hoda Jahandar * |
| Department of pharmacognosy, Faculty of Pharmacy and Pharmaceutical Sciences, Tehran Medical Sciences, Islamic Azad University (IAUPS), Tehran, Iran |
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Abstract: |
Abstract
High-performance liquid chromatography (HPLC) is recognized as a primary separation technique in modern pharmaceutical and biomedical analyses due to its exceptional efficiency and high sensitivity in detecting the analyte of interest. In the analysis of pharmaceutical samples, it is essential to ensure the reliability of the produced results. Method validation is a critical stage in the development of analytical methods, determining whether these methods are suitable and reliable for their intended purposes. The databases including PubMed, PubMed Central, Google Scholar, and ICHQ2R2 were searched using keywords such as HPLC, Validation, Accuracy, and Precision. To meet the requirements set by Good Manufacturing Practice (GMP) guidelines, pharmaceutical companies must establish a program to monitor and evaluate all their processes. The primary goal of this effort is to standardize all processes involved in the industry, including development, manufacturing, production, and analytical methods. This review article aims to provide insightful guidance on conducting validation for analytical methods that employed in pharmaceutical analysis. Specifically, it focuses on the validation process as per ICH Guidelines, which encompasses a comprehensive evaluation of performance characteristics such as accuracy, precision, specificity, linearity, working range, limit of detection, limit of quantification, robustness.
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| Keywords: HPLC, Accuracy, Precision, Validation |
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Type of Study: Research |
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