HPLC测定坎地沙坦酯氨氯地平片有关物质及降解产物

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。

Determination of Related Substances in Candesartan Cilexetil and Amlodipine Tablets by HPLC

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.