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

• Published in: Journal of pharmacy and pharmacology 2021-06, Vol.73 (6), p.758-766
• Main Authors: Shun, Liu, Yi-xuan, Wang, Hai-dan, Wang, Zhi-rong, Geng, Shi-hai, Yan
• Format: Article
• Language: English
• ISSN: 0022-3573; 2042-7158
• DOI: 10.1093/jpp/rgab017

Abstract Objectives The 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. Methods A 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. Key findings The 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%. Conclusions The 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.