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目的建立痛宁凝胶的高效液相色谱–质谱(HPLC-MS)指纹图谱,为其质量控制提供依据。方法采用Kromasil100-5 C18色谱柱(250 mm×4.6 mm,5μm);流动相:乙腈(A)–0.1%磷酸溶液(B),梯度洗脱;检测波长:240 nm;体积流量:1.0 m L/min;柱温:30℃;进样量:10μL。进行质谱分析时,流动相B用0.1%甲酸溶液替代。结果测定了10批痛宁凝胶的指纹图谱,提取18个色谱峰作为指纹图谱共有峰,采用MS法指认了12个共有峰,并将共有峰归属到各药材;10批样品相似度均大于0.9。结论该法重复性好,简便可靠,为痛宁凝胶的质量控制和评价提供了依据。
Objective To establish a HPLC-MS fingerprint of Tongning Gel and provide a basis for its quality control. Methods Kromasil 100-5 C18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of acetonitrile (A) -0.1% phosphoric acid solution (B) with gradient elution. The detection wavelength was 240 nm. / min; column temperature: 30 ℃; injection volume: 10μL. For mass spectrometry, mobile phase B was replaced with 0.1% formic acid solution. Results Fingerprints of ten batches of Tongling gel were determined, 18 chromatographic peaks were extracted as common peaks of fingerprint, 12 common peaks were identified by MS method, and the common peaks were assigned to each medicinal material. The similarity of ten batches of samples were all greater than 0.9. Conclusion The method is reproducible, simple and reliable, and provides the basis for the quality control and evaluation of Tongling gel.