四逆散指纹图谱相似度的分析研究

目的研究四逆散的高效液相色谱指纹图谱相似度,为科学评价及有效控制其质量提供可靠方法。方法利用高效液相色谱(HPLC)方法,梯度洗脱。色谱条件为:KromasilC18柱(4.6 mm×250 mm,5μm),流速1.0 ml/min,柱温30℃,流动相A为乙腈,流动相B为0.05%磷酸水,流动相A梯度洗脱(10%～90%乙腈),分析时间为150 min。结果 10批四逆散样品获得240 nm确定了20个共有峰,210 nm确定了24个共有峰,相似度分析结果均在0.99以上。结论四逆散的指纹图谱特征性及专属性强,可用于全面控制四逆散的质量,确保每批产品的均一性。

Similarity Analysis of HPLC Fingerprinting for SiNi Powder

Objective To establish a sensitive and specific HPLC method for controlling the quality of SiNi Powder.Methods HPLC method was applied for quality assessment of SiNi Powder and the conditions were as follows: Column:Kromasil C18 column(4.6 mm×250 mm,5 μm);flow-rate:1.0 ml/min;column temperature:30℃,mobile phase:acetonitrile(A)and H2O(acidified to 0.05% with phosphoric acid)(B).The concentrations of solvent A were 10% ～ 90% at 150 min,respectively.Results The HPLC chromatographic fingerprinting of SiNi Powder,showing 20 and 24 characteristic peaks,was established from 10 lots of SiNi Power products.The result of similarity analysis was over 0.99.Conclusion The chromatographic fingerprinting of SiNi Powder with high specificity can be used to control its quality and assure lot to consistency.