Application of the Analytical Procedure Lifecycle Concept to a Quantitative 1H NMR Method for Total Dammarane-Type Saponins

Dammarane-type saponins (DTSs) exist in various medicinal plants, which are a class of active ingredients with effects on improving myocardial ischemia and immunomodulation. In this study, quantitative 1H NMR method total DTSs herbal medicines was developed based the analytical procedure lifecycle. first stage (analytical design), Ishikawa diagram failure mode criticality analysis were used to conduct risk identification ranking. Plackett–Burman design central composite screen optimize critical parameter. Then, operable region obtained through modeling. second performance qualification), methodological indexes investigated quality by design. As examples continued verification, successfully applied determine pharmaceutical preparations botanical extracts. general quantify plants or preparations, provides new control strategy for products containing dammarane-type saponin.