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作 者:陈洪
机构地区:[1]上海现代哈森(商丘)药业有限公司,河南商丘476000
出 处:《中国医药工业杂志》2015年第3期287-289,共3页Chinese Journal of Pharmaceuticals
摘 要:建立了高效液相色谱法测定棓丙酯注射液的已知有关物质没食子酸。采用C18色谱柱,以甲醇∶水(用磷酸调至pH 3.0)为流动相,梯度洗脱,检测波长272 nm。结果显示棓丙酯与没食子酸分离良好。没食子酸在0.125-5.0μg/ml浓度范围内线性关系良好,最低检测限为7.5 ng/ml,平均回收率为100.1%,RSD为0.31%。An HPLC method was established for the determination of the related substance (gallic acid) in propyl gallate injection. A C18 column was used with the mobile phase of methanol " water (adjusted to pH 3 with phosphoric acid) by gradient elution at the detection wavelength of 272 nm. The results indicated that propyl gallate and gallic acid could be separated well. It was linear for gallic acid in the range of 0.125 - 5.0μg/ml. The low limit of detection was 7.5 ng/ml. The average recovery of gallic acid was 100.1%, with RSD of 0.31%.
分 类 号:TQ460.72[医药卫生—药物分析学] O657.72[化学工程—制药化工]
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