• Prof. Tejas J. Sharma
• Dr. Shivshankar D. Mhaske
• Sk.Bilal Sk. Yusuf

High-Performance Liquid Chromatography (HPLC) is a type of column chromatography that is commonly used in biochemistry and analysis to separate, identify, and quantify active chemicals. Most of the drugs in multi component dosage forms can be analyzed by HPLC method because of the several advantages like rapidity, specificity, accuracy, precision and ease of automation in this method HPLC methods development and validation play important roles in new discovery, development, manufacture of pharmaceutical drugs and various other studies related to humans and animals. An analytical procedure is developed to test a defined characteristic of the drug substance or drug product against established acceptance criteria for that characteristic. This review gives information regarding various stages involved in development and validation of HPLC method. Validation of HPLC method as per ICH Guidelines covers all the performance characteristics of validation, like Accuracy, precision, specificity, linearity, range and limit of detection, limit of quantification, robustness and system suitability testing.

Chromatography, HPLC, Column Chromatography, Method Development, Method Validation.

"A Review On HPLC Method Development And Validation ", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.11, Issue 11, page no.b492-b506, November-2024, Available :http://www.jetir.org/papers/JETIR2411165.pdf

"A Review On HPLC Method Development And Validation ", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.11, Issue 11, page no. ppb492-b506, November-2024, Available at : http://www.jetir.org/papers/JETIR2411165.pdf