Quality analysis of scutellarin ethyl ester and its related substances / 中国药学杂志

ABSTRACT

OBJECTIVE: To establish an analytical method for simultaneous determination of scutellarin ethyl ester and its related substances by RP-HPLC and identify the main related substances by UPLC-MS. METHODS: The assay was performed on a Kromasil C18 column (4.6 mm×250 mm, 5 μm),and gradient elution was used with methanol-water containting 0.2% formic acid. The flow rate was 1.0 mL·min-1 and the detection wave length was set at 335 nm. The structure of the main related substance was identified by high resolution MS. RESULTS: Under the separation condition, the related substances were completely separated from the principal components. The calibration curve of scutellarin ethyl ester showed good linearity in the concentration range of 5.005-1001 mg·L-1 (r2=0.9999). The average recovery was 99.6%. The main related substance was identified as scutellarin by LC-MS. The contents of total impurities and scutellarin were 1.14% and 0.89%, respectively. CONCLUSION: The method is simple, efficient and accurate, and can be used for the quality control of scutellarin ethyl ester.