Determination of raloxifene in human plasma using liquid chromatography- tandem mass spectrometry and its application in bioequivalence study
文献类型：期刊论文
| 作者 | Hu Wenjuan1 ; Zhang Yifan2; Chen Xiaoyan2; Guo Lixia2; Xia Yu2; Zhong Dafang1
|
| 刊名 | Chinese Journal New Drugs
 |
| 出版日期 | 2011 |
| 卷号 | 20期号:22页码:2233-2237 |
| 关键词 | raloxifene liquid chromatography-tandem mass spectrometry bioequivalence |
| ISSN号 | 1003-3734 |
| 其他题名 | 液相色谱-串联质谱法测定人血浆中雷洛昔芬及其在制剂生物等效性研究中的应用 |
| 文献子类 | Article |
| 英文摘要 | Objective: To develop a specific and sensitive liquid chromatography-tandem mass spectrometric (LC-MS/MS) method for determining raloxifene in human plasma, and to apply this method in a bioequivalence study of two raloxifene formulations. Methods: Plasma samples were incubated with 200muL beta-glucuronidsae in water at 37℃ for 10h, then 3mL n-hexane:dichloromethane:isopropanol (20 ∶10 ∶1) was added to perform liquid-liquid extraction. Agilent Zorbax SB-C18 column (150mm*4.6mm, 5mum) was used as the analytical column; the mobile phase consisted of methnol: 5mmol ·L~(-1) ammonium acetate solution:formic acid=65 ∶35 ∶0.1 at the flow rate of 0.6mL ·min~(-1). The Agilent 6460 triple quadrupole mass spectrometer was operated in multiple reaction monitoring mode (MRM) via positive atmospheric pressure chemical ionization (APCI) interface using the transitions m/z 474 m/z 112 for raloxifene, and m/z 478 m/z 116 for the internal standard. In a randomized crossover study, 24 healthy Chinese male subjects received a single oral administration of 60mg either test or reference raloxifene tablets after an overnight fast. Raloxifene concentration in plasma was determined using the validated LC-MS/MS method. Results: The linear range of raloxifene in human plasma was 0.20~250ng ·mL~(-1) and the lower limit of quantification (LLOQ) was 0.20ng ·mL~(-1). Inter-day and intra-day precision (RSD) was below 11.2%. The accuracy (RE) was between -4.0% and 1.3%. There was no significant difference in AUC0~120 between two formulation, but there was significantly different in C max and T max. Conclusion: This method is specific and sensitive, and can be successfully used for the bioequivalence study of two raloxifene formulations in healthy volunteers. The absorption of two raloxifene formulations was similar. The obviously reduced C max and increased T max of test formulation did not exhibit its dispersible tablet characteristics. |
| WOS研究方向 | Pharmacology & Pharmacy (provided by Clarivate Analytics) |
| 语种 | 中文 |
| CSCD记录号 | CSCD:4404686 |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/267865]  |
| 专题 | 上海药物代谢研究中心 |
| 通讯作者 | Zhong Dafang |
| 作者单位 | 1.Soochow University, Suzhou, Jiangsu 215006, China.; 2.Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China. |
| 推荐引用方式 GB/T 7714 | Hu Wenjuan,Zhang Yifan,Chen Xiaoyan,et al. Determination of raloxifene in human plasma using liquid chromatography- tandem mass spectrometry and its application in bioequivalence study[J]. Chinese Journal New Drugs,2011,20(22):2233-2237. |
| APA | Hu Wenjuan,Zhang Yifan,Chen Xiaoyan,Guo Lixia,Xia Yu,&Zhong Dafang.(2011).Determination of raloxifene in human plasma using liquid chromatography- tandem mass spectrometry and its application in bioequivalence study.Chinese Journal New Drugs,20(22),2233-2237. |
| MLA | Hu Wenjuan,et al."Determination of raloxifene in human plasma using liquid chromatography- tandem mass spectrometry and its application in bioequivalence study".Chinese Journal New Drugs 20.22(2011):2233-2237. |
入库方式： OAI收割
来源：上海药物研究所
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