Simultaneous determination of seven effective components in Shenkui Tongmai granules based on UHPLC-MS/MS.

Abstract

OBJECTIVES\nThe objective of the study was to establish the quality standard of the formulation of Shenkui Tongmai granules (SKTM) from the perspective of safety and effectiveness.\n\n\nMETHODS\nA sensitive and specific method to simultaneously detect seven effective components by ultra-high performance liquid chromatography-tandem-mass spectrometry (UHPLC-MS/MS) in SKTM, including calycosin 7-O-β-d-glucopyranoside, icariin, sodium danshensu, hyperoside, astragaloside IV, hesperidin, and salvianolic acid, was developed and validated. A Kromasil 100-3.5 C18 column with a mobile phase of 6.5 mmol/l ammonium acetate in acetonitrile was used to separate these above-listed components. Gradient programming was used with a flow rate of 0.2 ml/min, and the components were achieved in 13 min. Multiple reaction monitoring (MRM) in positive/negative mode was applied for the MS/MS detection.\n\n\nKEY FINDINGS\nThe analytical method was satisfactorily validated for linearity, accuracy and precision, repeatability and stability. The developed UHPLC-MS/MS method had high repeatability and accuracy and it was in a good linear relationship within their respective ranges (r = 0.9999) with the RSD value of the sample recovery of less than 5%.\n\n\nCONCLUSIONS\nThe current method established here is suitable for use in determining seven effective components in SKTM simultaneously, which may provide a new reliable method for overall quality control of SKTM.