Abstract

A REVIEW ON ANALYTICAL METHOD VALIDATION

Dr. Praveen Kumar Ashok, Ms. Anisha Arya, Moinuddin Mikrani

ABSTRACT

Method development is a continuous process that progress in parallel with the evolution of the drug product. The notion of phase-appropriate method development is critical one if time cost and efficiency are concerns. The goal and purpose of the method should reflect the phase of drug development. Analytical methods plays vital role in the process of identification, separation and then quantification of chemical components in natural materials or synthetic materials based on their chemistry. The main purpose of the analytical method development and validation is to prove that proposed analytical method is accurate, specific, precise and robust in the pharmaceutical industry for analysis of a drug moiety. The analytical method validation is essential for analytical method development and tested for specificity, linearity, accuracy, precision, range, limit of detection, limit ofquantification and robustness. In summary, analytical method development and validation confirms that the method is accurate, precise and can be used for the routine control analysis of drugs and drug product.

Keywords: Method validation, Linearity, Accuracy, HPLC.