Evaluation and Application of Best Practice in Analytical Method Validation

Abstract

Method validation is an important part of analytical chemistry to confirm that the method employed for a specific test is suitable for its intended use. As such, it is an essential requirement for any package of information submitted to regulatory agencies in support of new product marketing or clinical trial applications. Currently, there is no single source or final guideline on analytical method validation that helps analysts to perform validation in a systematic manner. Therefore, industry depends on the analyst's knowledge and experience to develop simple and efficient methods of analysis. The intention of this paper is to review regulatory requirements and role of the pharmacopeias and to study how analytical method development and validation are typically carried out at present, and to formulate this into a simple step by step approach. Such a template was not only used as the foundation of this research programme, but could also serve as a simple systematic guide for other practitioners and those new to the field. Furthermore, it was recognized that this protocol should satisfy the requirements of the most strategically important regulatory bodies.

Keywords:

• Method validation
• Pharmacopoeias role
• Best practice
• HPLC analysis
• Regulatory agencies
• 4-Hydroxybenzoic acid ester