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| HPLC法测定马来酸罗格列酮口腔喷雾剂的含量及有关物质 | |
| 引用本文： | 王炳璋,王雨鑫,张师愚,高永良.HPLC法测定马来酸罗格列酮口腔喷雾剂的含量及有关物质[J].西北药学杂志,2012,27(2):118-120. |
| 作者姓名： | 王炳璋 王雨鑫 张师愚 高永良 |
| 作者单位： | 1. 天津中医药大学,天津,300193;军事医学科学院毒物药物研究所,北京,100850 2. 天津中医药大学,天津,300193 3. 军事医学科学院毒物药物研究所,北京,100850 |
| 摘 要： | 目的建立马来酸罗格列酮口腔喷雾剂含量测定及有关物质的HPLC方法。方法采用Kromasil-100 5C18色谱柱(250mm×4.6mm,5μm);流动相为乙腈-0.01mol.L-1 NH4Ac溶液(冰醋酸调pH至6.0)(50∶50);检测波长为247nm;流速为1.0mL.min-1;柱温为35℃;进样量20μL。结果马来酸罗格列酮在2.0～20.0μg.mL-1范围内线性关系良好(r=0.999 9),平均回收率为100.3%,RSD为0.5%,检测限为40ng.mL-1。结论该方法简便,灵敏度高,重复性好,可用于马来酸罗格列酮含量测定和有关物质检查。 |
| 关 键 词： | 马来酸罗格列酮口腔喷雾剂 HPLC 含量测定 有关物质 |
Determination of Rosiglitazone Maleate Oral Spray and its related substances by HPLC |
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| WANG Bingzhang , WANG Yuxin , ZHANG Shiyu , GAO Yongliang.Determination of Rosiglitazone Maleate Oral Spray and its related substances by HPLC[J].Northwest Pharmaceutical Journal,2012,27(2):118-120. | |
| Authors: | WANG Bingzhang WANG Yuxin ZHANG Shiyu GAO Yongliang |
| Institution: | 1.Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China;2.Institute of Pharmacology and Toxicology,The Academy of Military Medical Sciences,Beijing 100850,China) |
| Abstract: | Objective To establish an HPLC method for the determination of Rosiglitazone Maleate Oral Spray and its related substances.Methods The column was Kromasil-100 5 C18(250 mm×4.6 mm,5 μm),with column temperature of 35 ℃,the mobile phase was acetonitrile-0.01 mol·L-1 ammonium acetate(adjusting pH to 6.0 by glacial acetic acid)(50∶50),with a flow rate 1.0 mL·min-1,and the detection wavelength was 247 nm.Results The linear range was 2.0-20.0 μg·mL-1(r=0.999 9),and the average recovery was 100.3%,with RSD 0.5%.The limit of detection was 40 ng·mL-1.Conclusion The method is convenient,accurate,repeatable and suitable for the determination of rosiglitazone maleate and its related substances. |
| Keywords: | Rosiglitazone Maleate Oral Spray HPLC assay related substances |
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