Abstract

A REVIEW: HPLC METHOD DEVELOPMENT AND VALIDATION

Hemaraj R. Patil*, Dr. S. T. Patil, Dr. S. P. Pawar

ABSTRACT

HPLC is the dominant separation technique in modern pharmaceutical and biomedical analysis because it results in highly efficient separations and in most cases provides high detection sensitivity. 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 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.

Keywords: High Pressure Liquid Chromatography (HPLC), Method development, Validation.