A REVIEW ARTICLE ON HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY ANALYTICAL METHOD DEVELOPEMENT AND VALIDATION
Sneha Patel*, Mitali Dalwadi, Dr. Chainesh Shah and Dr. Umesh Upadhyay
ABSTRACT
High-Performance Liquid Chromatography (HPLC) is an essential analytical technique used in pharmaceuticals,
environmental science, and food safety. This review paper discusses the critical aspects of HPLC method
development, focusing on optimization techniques such as column selection, temperature control, pH adjustments,
and flow rate optimization. It highlights the differences between gradient and isocratic elution methods, as well as
various detection techniques, including UV and mass spectrometry. Furthermore, the validation of HPLC methods
is explored, emphasizing regulatory requirements and key parameters such as precision, accuracy, specificity, and
robustness. The applications of HPLC in pharmaceutical analysis, environmental monitoring, and food safety are
examined, along with the challenges faced in method development and future directions in the field, including
emerging technologies like Ultra-High-Performance Liquid Chromatography (UHPLC). This comprehensive
overview underscores the significance of HPLC in analytical science and its evolving role in meeting the demands
of modern research and industry.
Keywords: HPLC, Separation, Development.
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