梯度洗脱法同时测定复方卡托普利尼群地平胶囊(Ⅱ)中3种成分的含量

Simultaneous determination of three contents in compound Captopril and Nitrendipine capsules(Ⅱ)by HPLC

目的建立同时测定复方卡托普利尼群地平胶囊(Ⅱ)中卡托普利、氢氯噻嗪和尼群地平含量的高效液相检测方法。方法采用色谱柱为Agilent ZORBAX Eclipse XDB-C18(4.6mm×250mm,5μm);以乙腈(A)-水(磷酸调节pH至3.0)(B)为流动相进行梯度洗脱;流速1.0mL/min;柱温:40℃;检测波长212nm。结果卡托普利、氢氯噻嗪和尼群地平分别在20.68～289.47μg/mL(r=0.9999),10.69～149.67μg/mL(r=0.9995)和10.44～146.16μg/mL(r=0.9999)范围内线性良好;平均加样回收率(n=6)分别为99.57%(RSD=0.89%),100.30%(RSD=1.20%),102.52%(RSD=1.59%)。结论 3种成分分离效果好,可同时测定,方法简便快速,结果准确可靠,可作为复方卡托普利尼群地平胶囊(Ⅱ)的质量控制方法。

Objective To develop a HPLC method for Simultaneous determination of Captopril,Hydrochlorothiazide and Nitrendipine in Compound Captopril and Nitrendipine Capsules（ Ⅱ ）. Methods The separation was carried out on a YMC-Pack Pro-C18 column（4.6 mmx 250 mm,5 IX m）with acetonitrile-water（adjusted pH to 3.0 with phosphoric acid）as the mobile phase in a gradient elution mode.The UV detection wave length was 212 nm.The flow rate was 1.0 mL/min.The column temperature was 40 ℃. Results The linear response ranges were：20.68 ~ 103.38 μg/mL for Captopril（r=0.9999）,10.69 -149.67 μg/mL for Hydrochlorothiazide（r=0.9995）and 10.44 - 146.16 μg/mL for Nitrendipine（r=0.9999）respectively.The average recovery rates of Captopril,Hydrochlorothiazide and Nitrendipine were 99.57%（RSD=O.89%）,100.30%（RSD=1.20%）,lO2.52%（RSD=I.59%）. Conclusion These three constituents＇ separation results are quite good,and it can also be determined simultaneously.This method is simple and quick,while the results are precise and reliable.It＇s very suitable for quality control of the compound captopril and nitrendipine capsules（ Ⅱ ）.