HPLC测定厄贝沙坦片有关物质及其稳定性考察.doc

PAGE PAGE 9 ?收稿日期：2015-04-07 作者简介： 梁艳芬（1989-），女，广东佛山人，硕士研究生，从事药物质量控制研究 E-mail: ?通讯作者： 李X（1959-），女，辽宁沈阳人，教授，硕士生导师，从事天然药物及化学药物质量标准研究Tel: E-mail: 此论文已发表于《食品与药品》2015年第4期 HPLC测定厄贝沙坦片有关物质 梁艳芬，许XX，黎XX，李 X? （广东药学院 药科学院，广东 广州 510006） 摘 要：目的 建立HPLC测定厄贝沙坦片有关物质含量的方法。方法 采用Agilent Pursuit C18色谱柱（4.6 mm×250 mm，10 μm），以乙腈-0.025 mol/L KH2PO4 溶液（35:65，用三乙胺调pH至6.0）为流动相，流速1.0 mL/min，柱温30 ℃，检测波长220 nm；用外标法计算有关物质A的含量，以峰面积归一化法计算其他杂质的含量。结果 主成分与有关物质A的分离度大于2.0，有关物质A的质量浓度与峰面积在0.1~0.6 μg/mL范围内线性良好（r=0.9981）；平均回收率为98.9 %（n=9），RSD为2.1 %。结论 方法简便、快速、准确可靠，适用于厄贝沙坦 关键字：厄贝沙坦；有关物质；含量测定；高效液相色谱法（列出3~6个关键词） 中图分类号：R917 文献标识码：A 文章编号：1672-979X（2015）00-0000-00 Determination of Irbesartan Related Substances by HPLC LIANG Yan-fen, XU Xx-xxxx, LI Xxxx-xxxx, LI Xxxx (School of Pharmacy, Guangdong Pharmaceutical University, Guangzhou 510006, China) Abstract: Objective To establish a high performance liquid chromatography method for the determination of related substance of irbesartan. Methods The Agilent Pursuit C18 (4.6 mm×250 mm, 10 μm) was adopted. The mobile phase consisted of acetonitrile-0.025 mol/L of potassium dihydrogen phosphate buffer (65:35, the pH was adjusted to 6.0 with triethylamine), with the flow rate of 1 mL/min; the detection wavelength was 220 nm and the column temperature was 30 ℃. The content of related substance A was calculated by external standard method; other related substances were calculated by peak area normalization method. Results Irbesartan could be completely separated with related substance A under this chromatographic condition. A good linear correlation was observed within the range of 0.1-0.6 μg/mL (r=0.9981) for irbesartan related substance A. The average recovery (n=9) was 98.9 %, with RSD of 2.1 %. Conclusion The method was simple, efficient and accurate for the analysis of Key Words: irbesartan; related substance; determination; HPLC 厄贝沙坦（irbesartan）是一种长效的血管紧张素Ⅱ（AngⅡ）受体拮抗剂，能抑制AngⅠ转化为AngⅡ，特异性地拮抗血管紧张素Ⅱ1型受体（AT1）[1]，通过选择性地阻断AngⅡ与AT1受体的结合，抑制血管收缩和醛固酮的释放，