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首页> 外文期刊>Luminescence: The journal of biological and chemical luminescence >Two validated spectrofluorimeteric and high performance liquid chromatography (HPLC) methods with fluorescence detection for the analysis of a new anti‐hepatitis C drug, daclatasvir hydrochloride, in raw material or tablet form and in biological fluids
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Two validated spectrofluorimeteric and high performance liquid chromatography (HPLC) methods with fluorescence detection for the analysis of a new anti‐hepatitis C drug, daclatasvir hydrochloride, in raw material or tablet form and in biological fluids

机译:具有荧光检测的两种验证的光谱氟位测液和高效液相色谱(HPLC)方法,用于分析新的抗丙型肝炎药物,盐酸Daclatasvir盐酸盐,原料或片剂形式和生物流体

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Abstract > Two sensitive and accurate methods have been developed for the estimation of daclatasvir (DAC) in its raw material, dosage form and in biological fluids. Method I is based on the measurement of DAC native fluorescence in methanol at 385?nm after excitation at 315?nm. The relationship between fluorescence intensity and concentration was found to be rectilinear over the linearity range (3.0–30.0?ng/ml). There were good per cent recoveries both in the dosage form (99.87?±?0.84) and in spiked human plasma (99.96?±?1.54%). Method II utilized reversed‐phase high performance liquid chromatography to estimate the antiviral agent daclatasvir hydrochloride against hepatitis C within 4.0?min on a C18 column (Eurosphere. 100‐5 C18, 150?×?4.6?mm, Germany) using a mobile phase consisting of acetonitrile and 0.1?M sodium dihydrogen phosphate (30:70, v/v) at pH?3.0 and with a fluorescence detector adjusted to 315?nm and 385?nm for excitation and emission respectively. The calibration curve was linear over the range (20.0–200.0?ng/ml) with SD 1.38%, error 0.56%, recovery 99.99?±?1.30% in tablets, recovery 100.28?±?1.73% in spiked urine and recovery 99.63?±?2.72% in spiked plasma.The new developed methods were successfully applied to the assay of the daclatasvir in tablet form and extended to its determination in real plasma, spiked human plasma and urine. The analytical performance of the proposed method was validated according to International Conference on Harmonization (ICH) guidelines. The proposed methods were compared with the results of a comparison method and it was found that there was no significant difference between the methods, as revealed by Student's t ‐test and variance ratio F‐test. </abstract> </span> <span class="z_kbtn z_kbtnclass hoverxs" style="display: none;">展开▼</span> </div> <div class="translation abstracttxt"> <span class="zhankaihshouqi fivelineshidden" id="abstract"> <span>机译:</span><Abstract Type =“main”XML:Lang =“en”> <标题类型=“main”>抽象</ title> >已经开发了两个敏感和准确的方法,以估计Daclatasvir(DAC)的原始材料,剂型和生物液中的材料。方法I基于在315℃的激发后在385℃下在385℃下测量甲醇的DAC原生荧光。发现荧光强度和浓度之间的关系在线性范围(3.0-30.0〜Ng / ml)上是直线性的。剂量形式的百分之次恢复(99.87?±0.84)和尖刺人血浆(99.96?±1.54%)。方法II利用反相高效液相色谱法以在C18柱(EuroSphere)的4.0℃内估计盐酸抗病毒剂DaclataSvir盐酸盐逆型丙型肝炎(EuroSphere。100-5 C18,150?×4.6?mm,德国)使用流动阶段由pHβ3.0和荧光检测器以乙腈和0.1·m磷酸二氢钠(30:70,v / v)组成,分别调节至315〜315〜385Ω·nm。校准曲线随着SD 1.38%的范围(20.0-200.0〜Ng / ml)线性,误差0.56%,恢复99.99?±1.30%,恢复100.28?±1.73%在尖刺尿液中,回收99.63?旋转等离子体中的2.72%。新的开发方法成功地应用于片剂形式的Daclatasvir的测定,并延伸到真实血浆中的测定,尖刺的人血浆和尿液。根据协调(ICH)指南的国际会议,验证了该方法的分析性能。将所提出的方法与比较方法的结果进行比较,发现该方法之间没有显着差异,如学生的 T </ i> - 差异和方差比F检验所透露。 </ p> </ abstract> </span> <span class="z_kbtn z_kbtnclass hoverxs" style="display: none;">展开▼</span> </div> </div> <div class="record"> <h2 class="all_title" id="enpatent33" >著录项</h2> <ul> <li> <span class="lefttit">来源</span> <div style="width: 86%;vertical-align: text-top;display: inline-block;"> <a href='/journal-foreign-26441/'>《Luminescence: The journal of biological and chemical luminescence》</a> <b style="margin: 0 2px;">|</b><span>2018年第8期</span><b style="margin: 0 2px;">|</b><span>共13页</span> </div> </li> <li> <div class="author"> <span class="lefttit">作者</span> <p id="fAuthorthree" class="threelineshidden zhankaihshouqi"> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Aboshabana Rasha&option=202" target="_blank" rel="nofollow">Aboshabana Rasha;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Shalan Shereen&option=202" target="_blank" rel="nofollow">Shalan Shereen;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Eid Manal&option=202" target="_blank" rel="nofollow">Eid Manal;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=El‐Enany Nahed&option=202" target="_blank" rel="nofollow">El‐Enany Nahed;</a> </p> <span class="z_kbtnclass z_kbtnclassall hoverxs" id="zkzz" style="display: none;">展开▼</span> </div> </li> <li> <div style="display: flex;"> <span class="lefttit">作者单位</span> <div style="position: relative;margin-left: 3px;max-width: 639px;"> <div class="threelineshidden zhankaihshouqi" id="fOrgthree"> <p>Department of Analytical Chemistry Faculty of PharmacyUniversity of MansouraMansoura Egypt;</p> <p>Department of Analytical Chemistry Faculty of PharmacyUniversity of MansouraMansoura Egypt;</p> <p>Department of Analytical Chemistry Faculty of PharmacyUniversity of MansouraMansoura Egypt;</p> <p>Department of Analytical Chemistry Faculty of PharmacyUniversity of MansouraMansoura Egypt;</p> </div> <span class="z_kbtnclass z_kbtnclassall hoverxs" id="zhdw" style="display: none;">展开▼</span> </div> </div> </li> <li > <span class="lefttit">收录信息</span> <span style="width: 86%;vertical-align: text-top;display: inline-block;"></span> </li> <li> <span class="lefttit">原文格式</span> <span>PDF</span> </li> <li> <span class="lefttit">正文语种</span> <span>eng</span> </li> <li> <span class="lefttit">中图分类</span> <span><a href="https://www.zhangqiaokeyan.com/clc/1345.html" title="生物光学">生物光学;</a></span> </li> <li class="antistop"> <span class="lefttit">关键词</span> <p style="width: 86%;vertical-align: text-top;"> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=biological fluids&option=203" rel="nofollow">biological fluids;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=daclatasvir (DAC)&option=203" rel="nofollow">daclatasvir (DAC);</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=fluorescence detection&option=203" rel="nofollow">fluorescence detection;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=HPLC&option=203" rel="nofollow">HPLC;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=method validation&option=203" rel="nofollow">method validation;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=real plasma&option=203" rel="nofollow">real plasma;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=spectrofluorimetry&option=203" rel="nofollow">spectrofluorimetry;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=tablets&option=203" rel="nofollow">tablets;</a> </p> <div class="translation"> 机译:生物液;Daclatasvir(DAC);荧光检测;HPLC;方法验证;真实等离子体;光谱氟状物;平板电脑; 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fluid channels to fluid paths is diagnosed</a> <b>[P]</b> . <span> 外国专利: <!-- 德国专利: --> DE102011087935A1 </span> <span> . 2013-06-13</span> </div> <p class="zwjiyix translation" style="max-width: initial;height: auto;word-break: break-all;white-space: initial;text-overflow: initial;overflow: initial;"> <span>机译:高性能液相色谱(HPLC)系统中使用的用于样品分离设备的可切换流体阀切换到诊断切换位置,在此位置诊断出流体通道向流体路径的泄漏 </span> </p> </li> </ul> </div> </div> </div> <div class="theme cardcommon" style="overflow: auto;display:none"> <h3 class="all_title" id="enpatent55">相关主题</h3> <ul id="subject"> </ul> </div> </div> </div> </div> <div class="right rightcon"> <div class="details_img cardcommon clearfix" style="margin-bottom: 10px;display:none;" > </div> </div> </div> <div id="thesis_get_original1" class="downloadBth" style="bottom: 19px;z-index: 999;" onclick="ywcd('0704023986118','4',7,2,1,'',this,24)" class="delivery" prompt="010401" title="通过人工服务将文献原文发送至邮箱" >获取原文</div> <div class="journalsub-pop-up" style="display: none"> <div 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