Abstract

A VOLUMINIOUS REVIEW: HPLC METHOD DEVELOPMENT AND VALLIDATION

Arti Gadade*, Santosh Waghmare and Hemant Kamble

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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. Chromatography is the backbone of separation science and is being used in all research laboratories and pharmaceutical industries universally. The present review article focuses on the principle, types, instrumentation, process validation, application, advantages and disadvantages of HPLC. 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.

Keywords: HPLC, Method development, Validation.