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HPLC法测定格列齐特片的含量

Determination of gliclazid in tablets by HPLC

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【作者】 黄碧莹姚秋燕李敏薇任斌李瑞明邓斌

【Author】 Huang Biying,Yao Qiuyan,Li Minwei,Ren Bin,Li Ruiming,Deng Bing(The First Affiliated Hospital of Sun Yat-sen University,Guangzhou 510080)

【机构】 中山大学附属第一医院中山大学附属第一医院 广州510080广州510080

【摘要】 目的:建立HPLC法测定格列齐特片的含量。方法:采用Diamonsil C18(4.6 mm×250 mm,5μm)色谱柱;流动相0.01 mol/L磷酸二氢钾缓冲液(pH 3.0)-乙腈(30∶70);流速1.5 ml/min;检测波长227 nm,以峰面积计算。结果:线性范围为8~104μg/ml,r=0.999 9。平均回收率为(99.10±1.40)%,RSD为1.41%(n=15)。结论:本方法简便快捷,结果准确,重现性好,可作为格列齐特片质量控制的有效方法。

【Abstract】 Object: To establish an HPLC method to measure the content of gliclazid.Methods: A Diamonsil C18 column(4.6 mm×250 mm,5 μm) was used.The mobile phase was a mixture of 30% phosphate buffer(0.01 mol/L of KH2PO4,pH 3.0) and 70% acetonitrile,and the flow rate was 1.5 ml/min.The detection wavelength was set at 227 nm.Results: The linear calibration curves were obtained over the range of 8 μg/ml to 104 μg/ml with r of 0.999 9.The recovery of the assay was(98.64±1.12)%(n=15).The coefficient of variation was 1.11%.Conclusion: The method was simple,convenient and precise and can be used for the quality control of gliclazid in tablets.

【关键词】 HPLC法格列齐特含量测定
【Key words】 HPLCgliclaziddetermination
  • 【分类号】R927.2
  • 【下载频次】63
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