HPLC法测定复方阿替洛尔片中阿替洛尔与硝苯地平的含量

HPLC Determination of Atenolol and Nifedipine in Compound Atenolol Tablets

目的:采用高效液相色谱法考察并建立测定复方阿替洛尔片中阿替洛尔与硝苯地平含量的方法。方法:色谱柱为Phe-nomenex—ODS 3柱(250 mm×4.60 mm,5 μm),甲醇-水-磷酸盐缓冲溶液(取磷酸二氢钾6.8 g,加水1000 mL溶解后,用磷酸调pH至3.0)-庚烷磺酸钠适量摇匀(65:35:3:0.13 g=V:V:V:W)为流动相,流速为1.0 mL·min～1,检测波长为240 nm,进样量为10μL。结果:阿替洛尔的线性范围为10-250μg·mL-1(r=0.9999),硝苯地平的线性范围为4—100 μg·mL-1(r=1.0000),平均回收率分别为99.45%和99.51%。结论:本法精密度好,结果准确可靠,适用于该复方制剂的质量检验分析。

Objective: Atenolol and nifedipine were determined by HPLC in compound atenolol tablets. Methods; Phenomenex - ODS 3 column(250 mm ×4. 60 mm,5 μm) ,the mobile phase consisted of a mixture of methanol -water - phosphate buffer (dissolved 6. 8 g KH2PO4in 1000 mL water, adjusted pH to 3. 0 with H3PO4) weigh a suil-able quantity of sodium heptanesulfonate at a flow rate of 1. 0 mL · min-1 (65: 35: 3: 0. 13 g = V: V: V: W) ,detection was done at 240 nm,the injection volume was 10 μL. Results .-The method offered good linearity 10 -250 μg · mL -1 for atenolol ( r = 0. 9999 ) , and 4-100 μg · mL-1 for nifedipine ( r = 1. 0000 ). The average recovery rates were 99. 45% and 99. 51% respectively. Conclusion; This method is accurate and reliable for the quality control of this compound preparation.