...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Journal of Young Pharmacists >Simultaneous Analytical Method Development of 6-Mercaptopurine and 6-Methylmercaptopurine in Plasma by High Performance Liquid Chromatography-Photodiode Array
【24h】

Simultaneous Analytical Method Development of 6-Mercaptopurine and 6-Methylmercaptopurine in Plasma by High Performance Liquid Chromatography-Photodiode Array

机译：高效液相色谱-光电二极管阵列同时开发血浆中6-巯基嘌呤和6-甲基巯基嘌呤的分析方法

获取原文
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Objective: 6-Mercaptopurin is antineoplastic drug that is included in antimetabolite group and is used in acute lymphoblastic leukemia medication. 6-Mercaptopurin is inactive pro-drug that will be metabolized into metabolites. One of its metabolites is 6-methylmercaptopurine. This study is aimed to optimize the analytical conditions and perform validation for the analysis of 6-mercaptopurine and 6-methylmercaptopurine in plasma. Method: Separation was performed using Waters 2996 HPLC, C18 SunfireTM column (5μm, 250 x 4.6 mm) with the mobile phase containing water-methanol-acetonitrile with gradient elution, and detected at 303 nm. 5-Fluorouracil was used as internal standard. Plasma extraction was done by liquid-liquid extraction using dichloromethane. Result: The method was linear at concentration range of 2.0 – 200.0 ng/mL with r > 0.9991 for 6-mercaptopurine and 20 – 2000 ng/mL with r > 0.9993 for 6-methylmercaptopurine. Accuracy and precision within-run and between-run fulfill the acceptance criteria with % RE and relative standard deviation (% RSD) ≤ 20% (LLOQ) and ≤ 15% (QC samples). 6-Mercaptopurine and 6-methylmercaptopurine was stable in plasma at least for 21 days when stored at -20oC. Conclusion: The bio-analytical method was sensitive, selective and all the parameters fulfilled the acceptance criteria of the EMA Bio-analytical Method Validation Guideline, 2011.
机译：目的：6-巯基嘌呤是抗肿瘤药，属于抗代谢药物组，用于急性淋巴细胞白血病药物。 6-巯基嘌呤是无活性的前药，将被代谢成代谢产物。它的代谢产物之一是6-甲基巯基嘌呤。这项研究旨在优化分析条件，并进行血浆中6-巯基嘌呤和6-甲基巯基嘌呤分析的验证。方法：使用Waters 2996 HPLC，C18 SunfireTM色谱柱（5μm，250 x 4.6 mm）进行分离，流动相中含有水-甲醇-乙腈并进行梯度洗脱，并在303 nm处检测到。使用5-氟尿嘧啶作为内标。通过使用二氯甲烷的液-液萃取进行血浆萃取。结果：该方法在6-巯基嘌呤的浓度范围为2.0 – 200.0 ng / mL，r> 0.9991时为线性;对于6-甲基巯基嘌呤的浓度范围为20 – 2000 ng / mL，r> 0.9993。批内和批间的准确度和精密度满足可接受标准，％RE和相对标准偏差（％RSD）≤20％（LLOQ）和≤15％（QC样品）。当在-20oC下保存时，6-巯基嘌呤和6-甲基巯基嘌呤在血浆中至少稳定21天。结论：该生物分析方法灵敏，选择性好，所有参数均符合《 2011年EMA生物分析方法验证指南》的接受标准。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号