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测定药片溶出度时如何选择空白溶液的配制?
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具体分析条件如下：（标样和样品工作溶液的稀释剂组分是不同的！） 测定Metformin HCl 850MG Tablets时：TEST Method：BP2007 标准溶液制备： STD: METFORMIN HCl (366-AS) STD POTENCY=100.0% STD WEIGHT=0.29859g-0.24330g=0.0552g=55.29mg STD STOCK SOLUTION: 55.29MG溶于100ml Dissolution Medium (= 0.68% pH6.8 KH2PO4 Buffer）中。 STD WORKING SOLUTION: 稀释：用HPLC级 Water 稀释4.0ml（上述过滤液）到200ml。 样品溶液制备： SAMPLE STOCK SOLUTION: 1 tablet 溶于900ml Dissolution Medium (= 0.68% pH6.8 KH2PO4 Buffer）; 100rpm， USP Method I（Basket）， 45minute 后；抽取20ml，用0.45um Nylon membrane filter 过滤，discard first 10ml filtrate. SAMPLE WORKING SOLUTION: 稀释：用HPLC级 Water 稀释3.0ml（上述过滤液）到250ml。 我选用的空白液是： 用HPLC级 Water 稀释4.0ml Dissolution Medium (= 0.68% pH6.8 KH2PO4 Buffer）到200ml而制成的溶液。您们认为如何？ 遇到类似情况如何选择空白液？有没有指导原则？ [search]空白溶液[/search] [ Last edited by penn007 on 2007-11-14 at 21:24 ] |
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按照下面的英文定义呢？ http://www.speciation.net/Public/Objects/Glossary/index.html? we_objectID=299&rb_select_l=B&rb_search=&PHPSESSID=363d Glossary ---- blank solution Blank Solution is a solution that does not contain a detectable amount of the analyte of interest. The blank solution is typically used for calibration purposes. Depending on its purpose the following blank solutions can be defined: 1. Calibration blank (the solution used for creating the zero concentration point of the calibration graph; this solution contains only the diluent used for making the standard solution) 2. Reagent blank (a blank solution that contains the reagents used to dissolve the samples such as acids used for digestion; the reading for this solution is typically substracted from sample readings) 3. Method blank (a blank solution that has been handled similar to a sample, and to which the same reagents have been added, that had contact to the same type of vessels and that was treated by a similar procedure. This solution than is handled to monitor any type of contamination taking place with the method used. The correct treatment of the analytical result for the blank solution does have a significant effect on the correctness of analytical results, especially for samples having analyte concentrations close to the limit of quantitation. Especially the measurement of the reagent and method blank must be well differentiated from the baseline correction. |
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