HPLC法测定清胃胶囊中奥美拉唑和甲硝唑的含量

Determination of Omeprazole and Metronidazole in Qingwei Capsules by HPLC

目的:建立测定清胃胶囊中奥美拉唑和甲硝唑含量的高效液相色谱法。方法:采用反相高效液相色谱法,CenturySIL ODS2(200 mm×4.6mm,5μm)色谱柱;0.01mol·L^(-1)磷酸氢二钠(用磷酸调pH值至7.6)-乙腈(75:25)为流动相;检测波长: 277 nm;体积流量:1.0ml·min^(-1);柱温:30℃。结果:奥美拉唑和甲硝唑进样量在5～50μg·ml^(-1)范围内与峰面积呈良好线性关系,r=0.999 9;奥美拉唑平均加样回收率为98.1%,RSD为1.4%(n=5);甲硝唑平均加样回收率为98.7%,RSD为1.3%(n =5)。结论:本方法操作简便,灵敏度高,准确性和重现性好。

Objective： To establish a reversed-phase HPLC assay for determination the contents of omeprazole and metronidazole in Qingwei capsules. Method： The chromatographic system consisted of CenturySIL ODS2 column （200mm × 4.6mm,5μm） and mobile phase consisted of 0.01mol·L^-1 disodium hydrogen phosphate solution（ adjusted to pH 7.6 with phosphoric acid）-acetonitrile （75：25 ） with a detection wavelength at 277nm. The flow rate was 1.0ml·min^-1 and the column temperature was 30℃. Result： The linear range of omeprazole and metronidazole was 5 -50μg·ml^-1,r =0. 999 9 and r =0. 999 8. The mean recovery was 98.1% with corresponding RSD of 1.4% （ n = 5 ） for omeprazole and 98.7% with corresponding RSD of 1.3% （ n = 5 ） for metronidazole. Conclusion ：This method is simple , reliable ,accurate, sensitive and reproducible.