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目的建立冠心Ⅴ号合剂的HPLC指纹图谱分析方法。方法采用Diamonsil C_(18)柱(4.6 mm×250 mm,5μm),检测波长:270 nm;以甲醇(A)-0.1%甲酸水溶液(B)为流动相,梯度洗脱;柱温:30℃;流速:1.0mL·min~(-1)。采用中药色谱指纹图谱相似度评价系统软件(2004A版),确定共有峰,计算相似度,并对其色谱峰进行了指认和归属。结果通过10批样品的测定,建立冠心Ⅴ号合剂HPLC指纹图谱,得到16个共有峰,相似度均在0.98以上。所建立的指纹图谱可用于冠心Ⅴ号合剂的定性鉴别。结论所建立方法专属性强、准确可靠、重复性好,为冠心Ⅴ号合剂的质量控制提供了有效方法。
Objective To establish a method for the HPLC fingerprinting of Guanxin V Mixture. Methods Diamonsil C_ (18) column (4.6 mm × 250 mm, 5 μm) was used. The detection wavelength was 270 nm. The mobile phase consisted of gradient elution with methanol (A) -0.1% ; Flow rate: 1.0 mL · min -1. The Chinese medicine chromatographic fingerprint similarity evaluation system software (2004A version), to determine the common peak, calculate the similarity, and its peak identified and assigned. Results The HPLC fingerprinting of Guanxin V was established by 10 batches of samples and the 16 common peaks were obtained. The similarities were all above 0.98. The established fingerprint can be used for the qualitative identification of coronary heart Ⅴ combination. Conclusion The established method is specific, accurate, reliable and reproducible. It provides an effective method for the quality control of Guanxin V Mixture.