冠心Ⅴ号合剂HPLC指纹图谱研究

Studies on HPLC Fingerprints of Guanxin Ⅴ Mixture

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 the HPLC fingerprints of Guanxin V Mixture for quality control. Methods HPLC method was adopted for the establishment of fingerprints of Guanxin V Mixture. The chromatographic conditions were as follows： Diamonsil C18（4.6 mm×250 mm, 5μm） column, the detection wavelength was at 270 nm, with methanol - 0.1% formic acid in water as the mobile phase by gradient elution（0 - 25 min, 5 % A→20 % A; 25 - 30 min, 20%A→40%A; 30-50rain, 40%A→60%A; 50-55min, 60%A→95%A; 55-65min, 95%A→95% A; 65 - 68min, 95 % A→5 % A; 68 - 70min, 5 % A→5 % A） , the temperature of column was 30℃, and the flow rate was 1.0 mL·min^-1. Chromatographic fingerprint evaluation system software （2004A Edition） was used to calculate the similarity of the samples, and common chromatographic peaks were identified and attributed. Results Fingerprints of 10 batches of Guanxin V Mixture were established and 16 common peaks were obtained in reference fingerprint. Good similarities with correlation coefficients over 0.98 were found in fingerprints between samples and standard fingerprint. The HPLC fingerprints could be utilized for the identification of Guanxin V Mixture. Conclusion This method is specific, reliable and reproducible, which can be used as a quality control method for Guanxin V Mixture.