A simple innovative spectrofluorometric method for the determination of alendronate in bulk and in pharmaceutical tablets

Elmalla Samah F.; Mansour Fotouh R.

摘要

Abstract > Sodium alendronate is the first in a pharmacological class known as bisphosphonates, used for treatment of various bone diseases. Assay of bisphosphonates by a spectroscopic technique is very challenging due to the fact that they lack chromophores and none of them are fluorescent. In this work, a simple method is presented for determination of alendronate in bulk and in pharmaceutical tablets using spectrofluorometry by exploiting the ability of alendronate to displace salicylate from the iron(III)–salicylate chelate, forming a non‐fluorescent colorless iron(III)–alendronate complex. The liberated salicylate is fluorescent and is equivalent to the mount of alendronate added. The response was linear over the concentration range 20–90?μM and the proposed method was validated according to the guidelines of the International Conference on Harmonization. The correlation coefficient was found to be 0.995 and the limit of detection was 7.5?μM. The method was successfully applied for determination of alendronate in the commercially available Osteonate? tablets. The average percent recovery ± percent relative standard deviation was found to be 102.118?±?2.033 which is congruent with the label claim of the dosage form. The results were also compared to a reported method using t ‐test and F ‐test at 95% confidence level; no significant differences were observed. The presented method is simple, fast, easy, cost‐effective and suitable for routine pharmaceutical analysis. </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”>摘要</标题> >醛酸钠是称为双膦酸盐的药理学级，用于治疗各种骨骼疾病。由于它们缺乏发色团而且它们都不是荧光，因此通过光谱技术测定通过光谱技术非常具有挑战性。在这项工作中，通过利用异丙酸盐从铁（III） - 仲晶酸盐螯合物，形成非荧光无色铁（III），提出了一种简单的方法，用于使用光谱荧光测定法测定块状和药物片中的块状和药物片剂中的醛膦酸盐。 - alendronate复合物。释放的水杨酸盐是荧光的，并且等同于加入的醛酸盐的支架。响应在浓度范围内为20-90Ω·μm，并且根据协调会议的指导方针验证了所提出的方法。相关系数被发现为0.995，检测极限为7.5≤μm。该方法成功地应用于商业上有夸核酸中的醛膦酸酯？平板电脑。发现平均回收±百分比相对标准偏差为102.118？±2.033，这与剂型的标签索赔一致。还将结果与使用 T </ i> -TEST和 F </ i>的方法进行比较，并且在95％的置信水平下进行;没有观察到显着差异。呈现的方法简单，快速，简便，成本效益，适用于常规药物分析。 </ 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>2019年第3期</span><b style="margin: 0 2px;">|</b><span>共7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=Elmalla Samah F.&option=202" target="_blank" rel="nofollow">Elmalla Samah F.;</a> <a href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=Mansour Fotouh R.&option=202" target="_blank" rel="nofollow">Mansour Fotouh R.;</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 Pharmaceutical Analytical Chemistry Faculty of PharmacyTanta UniversityTanta Egypt;</p> <p>Department of Pharmaceutical Analytical Chemistry Faculty of PharmacyTanta UniversityTanta 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=alendronate&option=203" rel="nofollow">alendronate;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=iron–salicylate&option=203" rel="nofollow">iron–salicylate;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=ligand‐exchange&option=203" rel="nofollow">ligand‐exchange;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=non‐chromophoric drugs&option=203" rel="nofollow">non‐chromophoric drugs;</a> <a style="color: #3E7FEB;" href="/search.html?doctypes=4_5_6_1-0_4-0_1_2_3_7_9&sertext=spectrofluorometry&option=203" rel="nofollow">spectrofluorometry;</a> </p> <div class="translation"> 机译：Alendronate;铁 - 水杨酸盐;配体交换;非发色药物;光谱荧光测定法; 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