| 周志勇,黄鹤飞,张烨.缬沙坦氨氯地平片有关物质研究[J].安徽医药,2016,20(4):651-655. |
| 缬沙坦氨氯地平片有关物质研究 |
| Research on related substance of valsartan Amlodipine |
| 投稿时间：2015-10-20 |
| DOI： |
| 中文关键词: 缬沙坦氨氯地平 有关物质 高效液相色谱 |
| 英文关键词: valsartan amlodipine related substance HPLC |
| 基金项目: |
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| 中文摘要: |
| 目的 建立缬沙坦氨氯地平片有关物质含量的测定方法。方法 采用高效液相色谱法,Agilent1220高效液相,(Eclipse plus,250 mm×4.6 mm,5 μm)色谱柱,以磷酸盐缓冲液(取三乙胺10 mL加水至1 000 mL,用磷酸调节pH值至2.8)为流动相A,以甲醇—乙腈(70∶30)为流动相B,进行线性梯度洗脱,流速为1.0 mL·min-1,检测波长为237 nm。结果 氨氯地平与杂质D分离度为14.44,缬沙坦与杂质B的分离度为9.46,且各物质之间有较好的分离；空白辅料对有关物质测定无干扰,专属性良好；强制降解试验中,杂质可与主峰完全分离。结论 该方法结果准确,重复性好,可靠性强,可用于测定缬沙坦氨氯地平片中的有关物质。 |
| 英文摘要: |
| Objective Aimed to establish an analytical method for related substances of valsartan Amlodipine tablets. Methods The sample was determined by HPLC (Agilent1220). The analysis was performed on Eclipse plus C18 column (250 mm×4.6 mm, 5 μm) with the detection wavelength at 237 nm. Using phosphate buffer (10 ml triethylamine volumetric to 1 000 mL,adjusted to pH 2.8 with phosphoric acid) as mobile phase A, methanol - acetonitrile (70∶30) as mobile phase B, and linear gradient, mobile phase was initiated at a flow rate of 1.0 mL·min-1.Results The resolution of amlodipine and impuritie Dwas 14.44;the resolution of amlodipine and impuritie Bwas 9.46, and there was good resolution between each substance. Conclusions This method is accurate, reproducible and reliable, which can be used to determine the related substances of valsartan Amlodipine tablets. |
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