| 引用本文: | 陈宁,毛柯,周卫,徐斌.HPLC测定坎地沙坦酯氨氯地平片有关物质及降解产物[J].中国现代应用药学,2014,31(4):462-465. |
| CHEN Ning,ZHOU Wei,MAO Ke,XU Bin.Determination of Related Substances in Candesartan Cilexetil and Amlodipine Tablets by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2014,31(4):462-465. |
|
| 摘要: |
| 目的 建立测定坎地沙坦酯氨氯地平片有关物质的高效液相色谱法。方法 采用Inertsil ODS-SP C18(150 mm× 4.6 mm，5 μm)色谱柱，以0.035 mol·L-1 KH2PO4(磷酸调pH 3.0)-甲醇-乙腈为流动相，梯度洗脱，检测波长238 nm，流速1.0 mL·min-1。结果 特异性杂质和破坏条件下产生的降解产物与主药分离较好，3批样品最大单个杂质为坎地沙坦酯杂质B，总杂质均<0.5%。结论 本法专属性强，灵敏度高，重现性好，能够有效控制产品质量。 |
| 关键词: 高效液相色谱法 坎地沙坦酯氨氯地平片 有关物质 降解产物 |
| DOI： |
| 分类号:R284.1；R917.101 |
| 基金项目: |
|
| Determination of Related Substances in Candesartan Cilexetil and Amlodipine Tablets by HPLC |
|
CHEN Ning1, ZHOU Wei1,2, MAO Ke1,2, XU Bin1
|
|
1.Jiangsu Province Institute of Materia Medica, Nanjing University of Technology, Nanjing 210009, China;2.School of Pharmaceutical Sciences, Nanjing University of Technolog, Nanjing 210009, China
|
| Abstract: |
| OBJECTIVE To establish an HPLC method for determining the related substances and decomposition products in Candesartan Cilexetil and Amlodipine tablets. METHODS An Inertsil ODS-SP C18 column was used with the mobile phase of 0.035 mol·L-1 sodium dihydrogen phosphate (pH 3.0)-acetonitrile-methanol by gradient elution at the detection wavelength of 238 nm. RESULTS The impurities were well separated from candesartan cilexetil and amlodipine. Candesartan cilexetil impurity B is the biggest one. The total content of related substance were <0.5%. CONCLUSION The method is simple, selective, accurate and reproducible. It is suitable for determination of related compounds in Candesartan Cilexetil and Amlodipine tblets. |
| Key words: HPLC Candesartan Cilexetil and Amlodipine tablet related substance decomposition product |
