HPLC法同时测定阿托伐他汀钙、阿司匹林、缬沙坦和苯磺酸氨氯地平制剂的含量

目的:建立同时测定阿托伐他汀钙、阿司匹林、缬沙坦和苯磺酸氨氯地平制剂含量的方法。方法:采用高效液相色谱法,内标为阿普唑仑。色谱柱为Hypersil ODS2-C18柱,流动相为甲醇-0.025 mol/L乙酸铵缓冲溶液(pH4.0,65∶35,V/V),流速为1.0ml/min,检测波长为245 nm,进样量为10μl,柱温为30℃。结果:阿托伐他汀钙、阿司匹林、缬沙坦和苯磺酸氨氯地平检测质量浓度均在5.0⁴0.0μg/ml范围内与各自峰面积积分值呈良好的线性关系(r分别为0.999 4、0.999 4、0.999 2、0.999 8);精密度、稳定性、重复性试验的RSD≤2.67%;平均加样回收率分别为97.28%、99.09%、97.53%、97.53%,RSD分别为1.14%、1.98%、0.95%、1.58%(n=9)。结论:该方法简便、快速、准确,可用于同时测定阿托伐他汀钙、阿司匹林、缬沙坦和苯磺酸氨氯地平制剂的含量。

Simultaneous Determination of Atorvastatin Calcium,Aspirin, Valsartan and Amlodipine Besylate Preparations by HPLC

OBJECTIVE： To establish a method for simultaneous determination of Atorvastatin calcium, Aspirin, Valsartan and Amlodipine besylate preparations. METHODS： HPLC method was adopted using alprazolam as internal standard. The determination was performed on Hypersil ODS2-C18 column with mobile phase consisted of methanol-0.025 mol/L ammonium acetate buffer solution （pH 4.0, 65 ： 35, V/V） at the flow rate of 1.0 ml/min. The detection wavelength was set at 245 nm, and column temperature was 30 ℃. The sample size was 10 ul. RESULTS： The linear ranges of atorvastatin calcium, aspirin, valsartan and amlodipine besylate were 5.0-40.0 ug/ml （r=0.999 4, 0.999 4, 0.999 2, 0.999 8）; RSDs of precision, stability and reproducibility tests were lower than 2.67%; average recoveries were 97.28% （RSD=1.14%, n=9）, 99.09% （RSD=1.98%, n=9）and 97.53% （RSD= 0.95%, n=9）, 97.53% （RSD=1.58%, n=9）. CONCLUSIONS： The method is simple, rapid and accurate, and can be used for the simultaneous determination of Atorvastatin calcium, Aspirin, Valsartan and Amlodipine besylate preparations.