This study aimed to develop a specific and reliable method to comprehensively analyze the chemical constituents in Shengmai injection (SMI) using high performance liquid chromatography coupled with tandem mass spectrometry. The qualitative analysis of SMI was achieved on a Kromasil 100-5C18 column, and the results demonstrated that a total of sixty-two compounds in SMI were unambiguously assigned or tentatively identified, and further, twenty-one compounds including fourteen saponins, six lignans and one L-borneol-7-O-[β-D-apiofuranosyl (1→6)]-β-D-gluco-pyranoside were quantified by HPLC-MS. Furthermore, L-borneol-7-O-[β-D-apio-furanosyl (1→6)]-β-D-glucopyranoside, originated from Radix ophiopogonis, was identified and quantified in SMI for the first time. The method validation results indicated that the methods were simple, specific and reliable. All the investigated compounds showed good linearity (r(2)≥0.9992) with a relatively wide concentration range and acceptable recovery at 90.13-109.09%. Consequently, the developed methods were successfully applied to ten batches of SMI samples analysis. The proposed methods may provide a useful and comprehensive reference for the quality control of SMI, and thus to provide supporting data for the quality control and application of SMI clinically.
Keywords: HPLC–MS; Identification; Quality control; Quantification; Shengmai injection.
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