Xinshenghua Keli is known as the "preferred prescription of postpartum", with large demand in the field of gynecologic medicine. However, the quality of the preparation is uneven in the market, so its clinical efficacy cannot be guaranteed. In order to improve and establish its quality control standard, high performance liquid chromatography (HPLC) was used to establish the fingerprint of Xinshenghua Keli. The detection was performed on Agilent 5 HC-C₁₈ (2) column(4.6 mm×250 mm, 5 microns) with methanol-0.1% formic acid solution as mobile phase for gradient elution, at a flow rate of 1 mL·min⁻¹ with column temperature of 25 °C. The injection volume was 10 μL and detection wavelength was set at the maximum value between 210.0 nm and 400.0 nm by Photo-Diode Array (PDA) detector. The fingerprint of 12 batches of high-quality Xinshenghua Keli was established and 43 common peaks were identified. The similarities of crowned products, 10 batches of ordinary ones made by Jiangsu Rongyu Pharmaceutical and 10 batches produced by different manufacturers were evaluated. The composition identification and source analysis for the common peaks were performed by comparing the retention time of herbal medicines and ultraviolet absorption spectrum, along with high performance liquid chromatography-mass spectrometry (HPLC-MS) technology. The established fingerprint of Xinshenghua Keli, has proven to have good precision, stability and repeatability through the methodology validation, so it can be used to comprehensively evaluate the quality of Xinshenghua Keli.
Keywords: HPLC-MS; Xinshenghua Keli; fingerprints.
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