清热解毒口服液HPLC指纹图谱

Fingerprint Chromatograms of Qingre Jiedu Koufuye by HPLC

目的：建立清热解毒口服液的高效液相色谱指纹图谱，为科学评价及有效控制其质量提供可靠方法。方法：利用HPLC方法，梯度洗脱，测定了12批清热解毒口服液样品。色谱条件为Shim—packVP-ODS柱（4．6mm×250mm，5μm），检测波长270nm，流速1．0mL·min^-1，流动相A乙腈-B0．02％磷酸水，梯度洗脱（0～12min，1％～15％A；12～22min，15％～20％A．22．32min．20％～25％A，32～40min，25％～45％A；40～50min，45％～55％A）。结果：12批清热解毒口服液样品有9个共有峰。相似度在0．911～0．972。结论：清热解毒口服液的指纹图谱特征性及专属性强，可用于全面控制清热解毒口服液的质量，确保每批产品的均一性。

Objective： To establish the fingerprint chromatograms for the quality evaluation of Qingre Jiedu Koufuye By HPLC. Method： The analysis was performed on a Shim-pack VP-ODS column （4.6 mm×250mm,5μm） with acetonitrile-water （containing 0.02% （v/v） phosphatacid） as mobile phase at a flow rate of 1.0 mL-rain-1 The detection wave-length was at 270 nm. Mobile phase A is acetonitrile; Mobile phase B for 0.02% phosphoric acid water, mobile phase A gradient elution （0-12 min, 1% -15% A; 12-22 min, 15% -20% A, 22-32 rain, 20%-25% A, 32-40 min, 25%-45% A; 40-50 rain, 45%-55% A）. Result： Twelve batch of Qingre Jiedu Koufuye sample has nine common peak. The analysis results of similarity between 0. 911 and 0. 972. Conclusion： Qingre Jiedu Koufuye fingerprint of the characteristic and strong specificity, and can be used in the comprehensive control Qingre Jiedu Koufuye quality, ensure every batch of product uniformity.