Organic acids are widely distributed in plants and related products, and participate in a wide range of metabolic pathways (e.g. tricarboxylic acid cycle), showing diverse pharmacological activities. As a widely used Chinese patent medicine, its adverse reactions are often reported. Therefore, we should further clarify the chemical components of Shenfu injection, and prepare strict quality standards to ensure the safety and effectiveness of its clinical use. Shenfu injection is prepared from red ginseng (steamed roots of Panax ginseng) and black prepared lateral roots of Aconitum carmichaelii (Heishunpian) by using modern extraction process, and organic acids are regarded as one of its main components. In current study, a hydrophilic interaction chromatography (HILIC) coupled with mass spectrometric method (HILIC-LC-MS) was developed and validated for the simultaneous determination of 14 organic acids, including cinnamic acid, ferulic acid, 4-hydroxylbenzoic acid, L-(+)-lactic acid, adipic acid, fumaric acid, caffeic acid, succinic acid, maleic acid, malonic acid, D-malic acid, (-)-shikimic acid, D-tartaric acid, and quinic acid in Shenfu injection. Satisfactory retention and separation were achieved for all organic acids on HILIC chromatographic column. Except cinnamic acid (231 μg•L⁻¹), lactic acid (113 μg•L⁻¹) and malonic acid (32.5 μg•L⁻¹), the limit of quantitation for the remaining 11 compounds were less than 10 μg•L⁻¹. D-Malic acid, malonic acid, quinic acid, L-(+)-lactic acid, and cinnamic acid were observed to have higher contents in Shenfu injection (>1.89 mg•L⁻¹), whereas caffeic acid and adipic acid were undetectable in all batches. Above all, the developed method is suitable for the simultaneous determination of organic acids in Shenfu and some other traditional Chinese medicine injections.
Keywords: Shenfu injection(SFI); hydrophilic interaction chromatography(HILIC); mass spectrometry(MS); organic acid; simultaneous determination.
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