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

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

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-0．025mol／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245nm，进样量为10ul，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5．0～40．0ug／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0．9994、0．9994、0．9992、0．9998）；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。

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.