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[关键词] 反相高效液相色谱法;妇血康胶囊;原儿茶酸;含量测定
Content determination of protocatechuic acid in Fuxuekang Jiaonang
YANG Yin-zhi,WANG Shang-shu.Hunan Sanjin Pharmaceutical Co.,TDL,Changde 415001,China
[Abstract] Objective To study a RP-HPLC methods that determined the protocatechuic acid content in Fuxuekang Jiaonang.Methods Fuxuekang Jiaonang was separated completely on an C18column,using a mixture of methanol,phosphate acid and water (13∶87∶0.2) as mobile phase,with UV detection at 256 nm.Results Protocatechuic acid has better linear correlation between 0.103 μg and 0.7725 μg,the results also have shown the recovery rate was 97.76%,RSD 1.01%.Conclusion The methods is very stable and accurate,and has good reappearance.It can be used for quality control of Fuxuekang Jiaonang.
[Key words] RP-HPLC;protocatechuic acid;Fuxuekang Jiaonang;content determination
妇血康胶囊由妇血康颗粒改剂型而来,是由滇桂艾纳香经提取、精制而制成的中药制剂。具有活血化瘀,止血调经的功效。用于瘀血阻滞所致的月经量多,经期延长。为了更全面地控制本产品质量,本文建立反相高效液相色谱法(RP-HPLC)测定妇血康胶囊中原儿茶酸的含量,控制妇血康胶囊的质量,以确保临床疗效。
1 仪器与试剂
1.1 仪器 日本岛津LC-10A高效液相色谱仪,SPD-10AV紫外检测器,CT-100恒温箱,LC2002数据处理系统,CSB6L-180D超声波清洗器,电子天平(AEG-45SM,1/10万)。
1.2 试剂 甲醇为色谱醇,磷酸为分析纯,水为重蒸馏水。原儿茶酸对照品(中国药品生物制品检定所,批号809-200102)。妇血康胶囊(产品开发部提供)。
2 方法与结果
2.1 色谱条件 (1)色谱柱:十八烷基硅烷键合硅胶柱Diamonsil(TM)C18(250×4.6 mm,5 μm)(迪马公司)。(2)流动相为甲醇∶水∶磷酸(13∶87∶0.2)。(3)检测波长:256nm。(4)流速:1.0 ml/min。(5)柱温:40 ℃。
2.2 对照品溶液的制备 精密称取经五氧化二磷干燥12 h的原儿茶酸对照品,分别加甲醇制成每1 ml含0.0412 mg、0.0515 mg的溶液,即得。
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