Abstract

ANALYTICAL METHOD VALIDATION–A REVIEW

A. K. Rath*, S. Sethy, V. V. B. K. Mishra, S. Pani

Abstract

Modern analytical techniques employ a range of techniques that vary from simple qualitative chemical test to the use of most sophisticated and expensive computer controlled instruments. This instrumentation provides the lower limit of detection required to assure the safety. In pharmaceutical industry the chemical composition of raw material, intermediates and finished products quality need to be monitored to ensure satisfactory consistency. Modern analytical techniques employ a range of techniques that vary from simple qualitative chemical test to the use of most sophisticated and expensive computer controlled instruments. The process of analytical method validation should demonstrate that the method is fit for its purpose. The validation should follow a plan that includes the scope of the method, the method performance characteristics and acceptance limits.

Keywords: Robustness, Ruggedness, Gravimetric, Thermogravimetric.