STEPS TO BE CONSIDERED DURING METHOD DEVELOPMENT AND VALIDATION FOR ANALYSIS OF RESIDUAL SOLVENTS BY GAS CHROMATOGRAPHY

Abstract

Residual solvents are potentially undesirable substances in all type of formulations when present above the permissible limits given by ICH guidelines in 1997 and their regulation must be properly in order to avoid their deleterious health effects. This review provides some important steps for method development and validation, to detect and quantitate residual solvents. Several steps which is to be considered for method development like column section (stationary phase and dimensions: column id, length, and film thickness), carrier gas selection (Nitrogen, Helium, flow rate), temperature programing (Initial temperature, initial hold, ramp rate, final temperature, and final hold) are discussed.