Abstract

European Journal of Mass Spectrometry
Volume 16 Issue 4, Pages 523–530 (2010)
doi: 10.1255/ejms.1091

Rapid and sensitive high-performance liquid chromatography- electrospray ionization tandem mass spectrometry for the quantification of potassium dehydroandrographolidi succinas and identification of its degradation products in potassium dehydroandrographolidi succinas injection

Juan Li,^a,b,* Shu-mei Song^a,b and Hong-min Liu^a,b,*
aSchool of Pharmaceutical Sciences, Zhengzhou University, 100 Science Road, Zhengzhou 450001, China
^bNew Drug Research and Development Center, Zhengzhou University, 100 Science Road, Zhengzhou 450001, China. E-mail: jli@zzu.edu.cn

A high-performance liquid chromatography-electrospray ionization tandem mass spectrometry (HPLC-ESI-MS/MS) method was established for the quantitative and qualitative analysis of potassium dehydroandrographolidi succinas (DAS-K) and its degradation products, respectively, in DAS-K injection, a widely used drug in China. The analytical HPLC was performed on a Waters RP-C18 column using 5 µmol m^?11 ammonium acetate(pH 3.0, adjusted by formic acid) and methanol as the mobile phase. Detection was performed on a Micromass Quattro micro triple quadrupole mass spectrometer with positive electrospray ionization. Three major degradation products were separated, detected and identified simultaneously by HPLC-ESI-MS/MS results. An HPLC method for the assay of DAS-K in its injection was then established. The multiple reaction monitoring function (m/z 550.14→m/z 297.04 for DAS-K) enabled the quantification of DAS-K down to 0.2 ng m^?11. The calibration graph was linear r better than 0.999, n = 7) in the concentration range 2.0–100 ng mL^?1. The values for the intra- and inter-day relative standard deviation (RSD) were less than 1.7% and 2.5% for DAS-K. The average recovery rate was over 98%, with an RSD less than 3.0%. This is the first report on the degradation products in DAS-K injection.

Keywords: HPLC-MS/MS, positive electrospray ionization, potassium dehydroandrographolidi succinas, multiple reaction monitoring, determination, degradation products, identification, collision-induced dissociation

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