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目的:建立测定复方氨氯地平缬沙坦片有关物质的HPLC方法。方法:用Agilent Extend C_(18)(250mm×4.6mm,5μm)色谱柱,以0.01mol·L~(-1)磷酸二氢钾溶液(pH 3.5)-(甲醇:乙腈=10:40)为流动相,梯度洗脱,流速1.0ml·min~(-1),柱温40℃,检测波长250nm,进样量20μl。结果:有关物质各杂质峰与主峰之间的分离良好,且已知单个杂质分离良好。结论:该方法准确可靠,专属性强,可用于复方氨氯地平缬沙坦片有关物质测定。
Objective: To establish a HPLC method for the determination of related substances of compound amlodipine valsartan tablets. Methods: An Agilent Extend C_ (18) (250 mm × 4.6 mm, 5 μm) column with 0.01 mol·L -1 potassium dihydrogen phosphate (pH 3.5) - (methanol: acetonitrile = 10: 40) Mobile phase, gradient elution, flow rate 1.0ml · min -1, column temperature 40 ℃, detection wavelength 250nm, injection volume 20μl. Results: The separation between the impurity peaks and the main peak of the relevant substances was good, and it was known that a single impurity was well separated. Conclusion: The method is accurate, reliable and specific. It can be used for the determination of related substances of compound amlodipine valsartan tablets.