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目的建立测定复方坎地沙坦酯片含量的HPLC法,为制剂的质量控制提供有效的分析方法。方法采用Zirchrom Kromasil ODS-1色谱柱(150 mm×4.6 mm,5μm),流动相为甲醇-乙腈-20mmol·L~(-1)磷酸二氢钾(体积比为52∶26∶22),流速为0.8 mL·min~(-1),检测波长为238 nm,进样量为20μL,柱温为室温。结果在选定的色谱条件下苯磺酸氨氯地平、坎地沙坦酯能良好分离;苯磺酸氨氯地平(以氨氯地平浓度计)和坎地沙坦酯质量浓度分别在4.00~6.00和6.40~9.60 mg·L~(-1)内与峰面积呈良好的线性关系(相关系数r分别为0.999 1和0.999 4);平均回收率分别为99.4%(RSD=0.7%)和100.2%(RSD=0.4%)。结论建立的方法简便、快捷、准确,适合复方坎地沙坦酯片中两种成分的同时测定。
OBJECTIVE To establish an HPLC method for determination of candesartan cilexetil ester tablets and to provide an effective analytical method for the quality control of the preparation. Methods The mobile phase was Zirchrom Kromasil ODS-1 (150 mm × 4.6 mm, 5 μm). The mobile phase was methanol-acetonitrile-20 mmol·L -1 potassium dihydrogen phosphate (volume ratio 52:26:22) 0.8 mL · min -1, the detection wavelength was 238 nm, the injection volume was 20 μL, and the column temperature was room temperature. Results Amlodipine besylate and candesartan cilexetil could be separated well under the selected chromatographic conditions. The concentration of amlodipine besylate (amlodipine concentration) and candesartan cilexetil concentration were 4.00 ~ 6.00 and 6.40 ~ 9.60 mg · L -1, respectively. The correlation coefficients (r) were 0.999 1 and 0.999 4 respectively. The average recoveries were 99.4% (RSD = 0.7%) and 100.2 % (RSD = 0.4%). Conclusion The established method is simple, rapid and accurate and suitable for the simultaneous determination of two components in candesartan cilexetil.