HPLC测定坎地沙坦酯氨氯地平片有关物质及降解产物

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

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。

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.