A Comprehensive Review on RP-HPLC Method Development, Validation, and Forced Degradation Studies According to ICH Guidelines

RP-HPLC remains the gold standard in the pharmaceutical industry for quality control of both drug substances and drug products. Checking the reliability of these procedures requires thorough validation according to ICH guidelines, especially Q2(R1). In establishing the stability-indicating capability of a method, it requires forced degradation studies or so-called stress testing as outlined under ICH Q1 guidelines. The paper reviews in detail the parameters required to validate a method, namely specificity, linearity, accuracy, precision, and robustness, and also describes the procedure to be followed for acid, base, oxidative, thermal, and photolytic stress conditions. This paper aims at serving as a strategic tool for an analytical chemist in the development of robust yet regulatory-compliant analytical procedures.