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Method for determining sodion content in diphosphonic acid monosodium salt compound

A monosodium salt and bisphosphonic acid technology, which is applied in the field of physical and chemical analysis of chemical substances, can solve the problems of lack of sodium ion content determination methods, high detection environment requirements, and strict processing conditions, so as to make up for uncertainties and ensure product quality. High-quality, high-sensitivity results

Active Publication Date: 2014-07-16
SICHUAN QINGMU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] At present, methods such as HPLC method, atomic absorption method, and sodium meter are mostly used in the determination of sodium ion content in compounds, such as Chinese patent CN200810138768. Method, patent CN200910251419.3 adopts atomic absorption method to measure the content of sodium ions in 1,3-propane sultone. On the 10th National Academic Report on Ion Chromatography in China, Yao Yongfeng and others disclosed the detection of potassium and sodium in water by ion chromatography. , Calcium, magnesium and fluoride chloride, nitrate, sulfate method, the instruments and equipment used in this method are expensive, the volume is large, the detection environment requirements are high, and the processing conditions are strict. At present, there is still a lack of simple and rapid detection methods using physical and chemical analysis, especially the lack of research on the determination of sodium ion content of bisphosphonic acid monosodium salt compounds by residual titration

Method used

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  • Method for determining sodion content in diphosphonic acid monosodium salt compound
  • Method for determining sodion content in diphosphonic acid monosodium salt compound
  • Method for determining sodion content in diphosphonic acid monosodium salt compound

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Experimental program
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Effect test

Embodiment 1

[0064] 1) Prepare the test solution: accurately weigh 250.0 mg of ibandronate sodium sample to be tested with an analytical balance, accurately add 10 ml of 0.5 mol / L sodium hydroxide titration solution, stir to dissolve the sample, and use it as the test solution;

[0065] 2) Titration reaction: add 0.5mol / L hydrochloric acid titration solution to the test solution prepared in step 1 and carry out neutralization titration;

[0066] 3) End point judgment: use the potentiometric method to judge the titration end point;

[0067] 4) content determination of sodium ion: according to the hydrochloric acid titrant volume of sample content and consumption, calculate the content of sodium ion in the ibandronate sodium sample to be measured according to the formula shown in formula I;

[0068] Repeat steps 1-4 twice, the three measured values ​​are 6.62%, 6.58%, 6.67%, respectively, the average content of sodium ions in the sample is 6.62%, and the relative average deviation dr is 0.47...

Embodiment 2

[0070] 1) Prepare the test solution: accurately weigh 235.6 mg of ibandronate sodium sample to be tested with an analytical balance, accurately add 10 ml of 0.5 mol / L sodium hydroxide titration solution, stir to dissolve the sample, and use it as the test solution;

[0071] 2) Titration reaction: Add 3 drops of phenolphthalein indicator solution, add 0.5mol / L sulfuric acid titration solution to the test solution prepared in step 1 for neutralization titration;

[0072] 3) End point judgment: until the pink color disappears;

[0073] 4) content determination of sodium ion: according to the sulfuric acid titration solution volume of sample content and consumption, calculate the content of sodium ion in the ibandronate sodium sample to be measured according to the formula shown in formula I.

[0074] Repeat steps 1-4 twice, the three measured values ​​are 6.67%, 6.63%, 6.65%, the average content of sodium ions in the sample is 6.65%, and the relative average deviation dr is 0.20%...

Embodiment 3

[0076] 1) Prepare the test solution: accurately weigh 201.3 mg of ibandronate sodium sample to be tested with an analytical balance, accurately add 20 ml of 0.1 mol / L sodium hydroxide titration solution, stir to dissolve the sample, and use it as the test solution;

[0077] 2) Titration reaction: add 3 drops of phenolphthalein indicator solution, add 0.2mol / L hydrochloric acid titration solution to the test solution prepared in step 1 for neutralization titration;

[0078] 3) End point judgment: until the pink color disappears;

[0079] 4) content determination of sodium ion: according to the hydrochloric acid titrant volume of sample content and consumption, calculate the content of sodium ion in the sodium ibandronate sample to be measured according to the formula shown in formula I.

[0080] Repeat steps 1-4 twice, the three measured values ​​are 6.61%, 6.66%, 6.65%, the average content of sodium ions in the sample is 6.64%, and the relative average deviation dr is 0.30%. ...

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Abstract

The invention provides a method for determining sodion content in a diphosphonic acid monosodium salt compound. A titration end point is judged by means of a potential method or an indicator method, and the method for determining the sodion content in the diphosphonic acid monosodium salt compound is simple, rapid, high in accuracy of analysis results, low in cost and effective.

Description

technical field [0001] The invention relates to the field of physical and chemical analysis of chemical substances, in particular to a method for determining sodium ion content in bisphosphonic acid monosodium salt compounds. Background technique [0002] Bisphosphonic acid and its derivatives are a kind of oligomeric phosphonic acid ash compounds that are characterized by P-C-P, similar to natural pyrophosphoric acid. In the early 1960s, Yuxiong and others were inspired by the inhibitory effect of pyrophosphate in the body on heterogeneous calcification, and pioneered the development of such compounds. Bisphosphonic acid and its salts are currently one of the main drugs used to prevent and treat various metabolic bone diseases and osteoporosis, which mainly destroy cellular bone resorption. A lot of practice has proved that bisphosphonic acid and its salts are easily absorbed by bone tissue and prevent the dissolution of hydroxyphospatite crystals, thereby achieving the pu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N31/16
Inventor 王颖胡同军
Owner SICHUAN QINGMU PHARMA CO LTD
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