Analytical Method Development and Validation Strategies for Quantitative Determination of Novel Drugs Using High Performance Liquid Chromatography
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2026
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| _version_ | 1866901852156592128 |
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| author | Sridhar Siddiraju* |
| author_facet | Sridhar Siddiraju* |
| contents | <p><span lang="EN-US">High Performance Liquid Chromatography (HPLC) has emerged as a cornerstone analytical technique in pharmaceutical research and quality assurance owing to its excellent separation efficiency, sensitivity, and reproducibility. The rapid development of structurally complex and potent novel drug molecules necessitates the establishment of robust and scientifically sound analytical methods for their accurate determination. HPLC method development involves a systematic evaluation and optimization of chromatographic variables including stationary phase selection, mobile phase composition, buffer pH, flow rate, column temperature, detection wavelength, and sample preparation procedures. Recent advancements emphasize the integration of Quality by Design (QbD) principles and Design of Experiments (DoE) to identify critical method parameters and achieve method robustness with minimal experimental trials. Following development, analytical methods must be validated in accordance with International Council for Harmonisation (ICH) Q2(R1) guidelines to establish specificity, linearity, accuracy, precision, robustness, limit of detection, and limit of quantification. This review presents a comprehensive and original discussion on contemporary approaches to HPLC method development and validation, with particular emphasis on development strategies applied to novel pharmaceutical compounds in bulk and finished dosage forms</span></p> |
| format | Recurso digital |
| id | zenodo_https___doi_org_10_5281_zenodo_18640178 |
| institution | Zenodo |
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| publishDate | 2026 |
| publisher | Zenodo |
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| spellingShingle | Analytical Method Development and Validation Strategies for Quantitative Determination of Novel Drugs Using High Performance Liquid Chromatography Sridhar Siddiraju* HPLC, Analytical Method Development, Validation, Novel Drugs, QbD, ICH Guidelines <p><span lang="EN-US">High Performance Liquid Chromatography (HPLC) has emerged as a cornerstone analytical technique in pharmaceutical research and quality assurance owing to its excellent separation efficiency, sensitivity, and reproducibility. The rapid development of structurally complex and potent novel drug molecules necessitates the establishment of robust and scientifically sound analytical methods for their accurate determination. HPLC method development involves a systematic evaluation and optimization of chromatographic variables including stationary phase selection, mobile phase composition, buffer pH, flow rate, column temperature, detection wavelength, and sample preparation procedures. Recent advancements emphasize the integration of Quality by Design (QbD) principles and Design of Experiments (DoE) to identify critical method parameters and achieve method robustness with minimal experimental trials. Following development, analytical methods must be validated in accordance with International Council for Harmonisation (ICH) Q2(R1) guidelines to establish specificity, linearity, accuracy, precision, robustness, limit of detection, and limit of quantification. This review presents a comprehensive and original discussion on contemporary approaches to HPLC method development and validation, with particular emphasis on development strategies applied to novel pharmaceutical compounds in bulk and finished dosage forms</span></p> |
| title | Analytical Method Development and Validation Strategies for Quantitative Determination of Novel Drugs Using High Performance Liquid Chromatography |
| topic | HPLC, Analytical Method Development, Validation, Novel Drugs, QbD, ICH Guidelines |
| url | https://doi.org/10.5281/zenodo.18640178 |