Abstract

INTRODUCTION TO CHROMATOGRAPHY AND HPLC METHOD DEVELOPMENT AND VALIDATION: A SHORT REVIEW

*Siddheshwar Rohidas Kudke, Jyoti Pradhan Khot, Prathmesh Sunil Kushare

ABSTRACT

Analytical methods development and validation play important roles in new discovery, development, manufacture of pharmaceutical drugs and various other studies related to humans and animals. Chromatography is the backbone of separation science and is being used in all research laboratories and pharmaceutical industries universally. High-performance liquid chromatography (HPLC) is dominant separation technique where analytes are separated by passage through a column packed with micro metersized particles. Now a day reversed-phase chromatography is the most commonly used separation technique in HPLC. This review discusses the many steps involved in the development and validation of the HPLC method and covers the principle, introduction, types, instrumentation, validation, application of HPLC. Validation of HPLC method gives information about various stages and parameters like accuracy, precision, linearity, Limit ofdetection, Limit of quantification, specificity and robustness.Validation should be done as per regulatory guidelines such as ICH guidelines. They can be used to make judgments on how to deliver a medicine to patients, and they play a key role in novel drug discovery, development, and manufacturing, as well as a variety of other human and animal studies. Validation of analytical procedures is essential during medication development and production to ensure that they are fit for their intended purpose.

Keywords: Analytical, High Pressure Liquid Chromatography (HPLC), Method development, Method Validation, Chromatography, Accuracy, Precision, Specificity.