高效液相色谱法测定棓丙酯注射液含量及有关物质(1)
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[摘要] 目的：建立棓丙酯注射液含量与有关物质测定的高效液相色谱分析方法。方法：采用Diamonsil C18柱(250 mm×4.6 mm，5 μm)，流动相为甲醇-水(55∶45)(用磷酸调pH值为3.0)，检测波长为274 nm，流速为1.0 ml/min，柱温为25℃，进样量为10 μl。结果：没食子酸与棓丙酯主峰达到基线分离，分离度符合要求。没食子酸最低检出量为0.8 ng，棓丙酯最低检出量为0.9 ng。3批样品中有关物质的平均含量为0.11%。样品浓度在19.02～57.06 μg/ml的范围内与峰面积呈良好的线性关系(r=1.000)，平均回收率为99.8%，RSD为0.39%。结论：本检测方法专属性强、结果可靠、重复性良好，可用于棓丙酯注射液的质量控制。
[关键词] 棓丙酯注射液；有关物质；含量测定；高效液相色谱法
[中图分类号]R927 [文献标识码]A [文章编号]1673-7210(2009)06(c)-063-03
Content determination of Propylgallate Injection and its related substances by HPLC
XU Xingmin1, LI Jianhe2, WU Xiaoqun1, PENG Liubao2, CAO Junhua2, LUO Xia2
(1.Department of Pharmacy, People's Hospital of Xiangxi Autonomous Perfecture, Jishou 416000, China；2. Department of Pharmacy, the Second Xiangya Hospital, Central South University, Changsha 410011, China)
[Abstract] Objective: To establish a high performance liquid chromatograph(HPLC) method for the determination of Propylgallate Injection and its related substances. Methods: The chromatographic separation was performed on a Diamonsil C18 column(250 mm×4.6 mm, 5 μm) with mobile phases of methyl alcohol-water(55∶45) (pH adjusted to 3.0 with phosphoric acid). The detection wavelength was 274 nm, the flow rate was 1.0 ml/min, the column temperature was 25℃ and the sample size was 10 μl. Results: Gallic acid and propylgallate were well separated by this method, and the separation degree was accorded with the demands. The detection limit of gallic acid and propylgallate was 0.8 ng and 0.9 ng, respectively. The average content of the related substances in three batches of samples was 0.11%, the linear range of propylgallate was 19.02-57.06 μg/ml(r=1.000) and the average recovery was 99.8% with a RSD of 0.39%. Conclusion: The method is sensitive, accurate, rapid and can be used in the quality control of Propylgallate Injection.
[Key words] Propylgallate Injection; Related substance; Content Determination; HPLC
棓丙酯(propylgallate)是在对活血化瘀中药赤芍深入研究的基础上，对其主要有效成分没食子酸酯进行结构修饰而得到的具有更强生物效应的化合物。临床用于预防和治疗脑血管疾患、冠心病、心绞痛、外科手术后的并发症血栓性深静脉炎等，具有良好的疗效[1-6]。笔者在研究开发棓丙酯注射液时 ......
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