Method Validation for HPLC Analysis of Related Substances in Pharmaceutical Drug Products

Abstract

In this chapter we outline the general requirements for analytical method validation for HPLC analysis of related substances in pharmaceutical products. Most of the discussion is based on method validation for pharmaceutical products of synthetic origin. Even though most of the requirements are similar for other types of pharmaceutical drug products (e.g., biopharmaceutical drug products), detailed discussion of method validation for other types of pharmaceutical drug products is outside the scope of this chapter. The discussion focuses on current regulatory requirements in the pharmaceutical industry. Since the expectations for method validation are different at different stages of the product development process, the information given in this chapter is most suitable for final method validation according to the ICH requirements to prepare for regulatory submissions (e.g., NDA). Even though the method validation is related to HPLC analysis, most of the principles are also applicable to other analytical techniques (e.g., TLC, UV).