Xây dựng và thẩm định quy trình định tính, định lượng rutin trong dược liệu Trà hoa vàng bằng phương pháp sắc ký lỏng hiệu năng cao

Abstract

Rutin is a major active compound in Flos Camelliae chrysanthae, and could be used as the marker for identification and assay the herbal. This study developed and validated a process for qualitative and quantitative analysis of rutin using high-performance liquid chromatography (HPLC). The chromatographic conditions include: Hitachi HPLC system with DAD detector, Inertsil C18 ODS-3 reversed-phase column (5 µm; 25 cm × 4.6 mm), flow rate of 1.0 mL/min, and sample injection volume of 10 µL. Gradient elution was performed with a mobile phase consisting of acetonitrile and 0.1% phosphoric acid solution. The quantification method has been validated to meet the requirements for system suitability, specificity, linearity, repeatability, intermediate precision, accuracy, limits of detection (LOD) and quantification (LOQ), in accordance with ICH guidelines.