CN103698370A - New metformin hydrochloride detection method - Google Patents
New metformin hydrochloride detection method Download PDFInfo
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- CN103698370A CN103698370A CN201310572565.2A CN201310572565A CN103698370A CN 103698370 A CN103698370 A CN 103698370A CN 201310572565 A CN201310572565 A CN 201310572565A CN 103698370 A CN103698370 A CN 103698370A
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Abstract
The present invention provides a new method for determining metformin hydrochloride content by using an ion selective electrode method. According to the present invention, a pCL-1Q9 type chloride ion selective electrode is adopted as a work electrode, a 217 type saturated calomel electrode is adopted as a reference electrode, a stirring rate is 120 rpm/min, a stirring time is 3 min, the pH value is 4-6, a temperature is 18 DEG C, a buffer solvent is a total ionic strength adjustment buffer solution comprising potassium nitrate and sodium citrate, and a standard curve method is adopted as the method for quantitative analysis of the drug metformin hydrochloride effective component content; and compared with the traditional method, the method of the present invention has characteristics of simple experiment equipment, low test cost, simpleness, rapidness, accurate determination result, wide linear range and high sensitivity, and is the easiest and feasible analysis method for determining the metformin hydrochloride content.
Description
Technical field
The invention belongs to the technical field of Pharmaceutical Analysis, be specifically related to the potentiometric analysis method of Metformin hydrochloride quantitative test, especially the assay method of active constituent content in Metformin hydrochloride medicine.
Background technology
Ion-selective electrode is that a kind of optional membrane of utilization produces selective response to measure or to indicate the electrode of effects of ion activity to specific ion.The principle of work of ion selective electrode method is as follows: indicator electrode (also claims working electrode, the present invention uses chlorion to select electrode) electrical potential energy indicate the variation of tested ion activity (or concentration), the current potential of contrast electrode (the present invention uses the full mercurous chloride electrode that closes) is not subject to test solution to form the impact changing, there is more constant numerical value, by indicator electrode and contrast electrode, jointly immerse while forming primary element in test solution and measure the electromotive force obtaining, according to nernst equation, can obtain tested ion activity (or concentration).The method instrument and equipment is inexpensive, light, it is simple and easy, quick, reliable to operate, the range of linearity is wide, selectivity and highly sensitive (detection limit 10
-5mg/ml), can directly measure liquor sample, the color of solution and turbidity generally do not affect the result of test, are simple and easy, the most feasible a kind of new methods of measuring Metformin hydrochloride.
Metformin hydrochloride (C
4h
11n
5hCl) chemistry 1,1-Dimethylbiguanide hydrochloride by name.Metformin hydrochloride is a kind of hypoglycemic agent, has the blood sugar tolerance that improves diabetes B patient, reduces the effect of basis and postprandial blood sugar.The mechanism of action of Metformin hydrochloride is different from the oral anti-blood sugar medicine of other type, it can reduce the generation of glycogen, reduce intestines to sugared absorption, and can be by increasing the picked-up of periphery sugar and the susceptibility that utilization improves insulin, different from sulfonylureas, Metformin hydrochloride can not produce hypoglycemia (except special circumstances-see points for attention) to the patient of diabetes B patient or euglycemia.After Metformin hydrochloride treatment, the secretion of insulin remains unchanged, and reduce FPI level and every day plasma insulin level.
At present, the method for measuring Metformin hydrochloride amount mainly be take high performance liquid chromatography and ultraviolet spectrophotometry as main, but these methods need sample to carry out complicated processing before mensuration, and the range of linearity is not wide, also very high to the requirement of sample preparation.In addition, expensive, the complicated operation of these instruments and Pharmaceutical Analysis process have secondary environmental pollution, analysis cost high.
Summary of the invention
The present invention aims to provide a kind of new method of simple, Accurate Determining Metformin hydrochloride content.
Summary of the invention comprises: test electrode, test condition, total ionic strength adjustment buffer degree regulator solution and quantitative analysis method.
1) test electrode
This invention be take pCL-1Q9 type chlorion and is selected the content that electrode (magnetic electronic Science and Technology Ltd. is got in Shanghai) is contrast electrode (Shanghai Lei Ci instrument plant) testing drug Metformin hydrochloride as working electrode, 217 type saturated calomel electrodes.
2) test condition
This invents described condition determination: stir speed (S.S.) 120rpm/min, mixing time are 3min, and pH 4～6,18 ℃ of temperature, and buffer solvent is that total ionic strength adjustment buffer degree regulates buffer solution.The present invention is preferred for measuring the Metformin hydrochloride content in Metformin hydrochloride medicine.
3) total ionic strength adjustment buffer degree regulator solution
The total ionic strength adjustment buffer that this invention is used is potassium nitrate and sodium citrate.
4) quantitative analysis method
this invention be take calibration curve method as the main method of quantitative test medicine Metformin hydrochloride active constituent content.
Embodiment
Below in conjunction with embodiment, describe the present invention in detail; but the following examples are only preferably embodiment of the present invention; protection scope of the present invention is not limited to this; anyly be familiar with those skilled in the art in the technical scope that the present invention discloses; according to technical scheme of the present invention and inventive concept thereof, be equal to replacement or changed, within all should being encompassed in protection scope of the present invention.
Total ionic strength adjustment buffer degree regulates the preparation of buffer solution: in 50ml beaker, add 20ml deionized water, 25g potassium nitrate and 30g sodium citrate, be stirred to completely and dissolve.Beaker is placed in cooling bath, slowly adds HNO
3solution, and carefully stir evenly, with PHS-2C type precision acidity meter (Shanghai Lei Ci instrument plant), test, making pH is 5.Be cooled to room temperature, proceed in 250ml volumetric flask, with deionized water, be diluted to graticule, fully shake up.
The foundation of Metformin hydrochloride typical curve: with AL204 type electronic balance (Shanghai plum Teller-holder benefit Instrument Ltd.) take respectively 0,20.3,61.5,103.3,144.0,184.5mg Metformin hydrochloride standard items (Di Kang pharmaceutcal corporation, Ltd provides), proceed to respectively in the volumetric flask of 6 50ml, with deionized water, be diluted to graticule, shake up and obtain the dioxopromethazine hydrochloride standard solution that concentration is 0,0.00245,0.00743,0.0125,0.0174,0.0223 mol/L.First 50ml deionized water is added in beaker, add 2 buffer solution, open magnetic force heating stirrer switch, at 18 ℃ of stir speed (S.S.) 120rpm/min, temperature, after cleaning electrode is stable to current potential, read blank electromotive force.Get volumetric flask No. 1, all proceed in clean and dry 50ml beaker, add 2 buffer solution (final pH=5～6 of gained solution), at 18 ℃ of stir speed (S.S.) 120rpm/min, temperature, stir 3min, stop 1min, read and record equilibrium potential value.Then use the same method, measure respectively the equilibrium potential value of test solution in 2,3,4,5, No. 6 volumetric flasks.Measurement result be take the concentration (mol/L) of Metformin hydrochloride as horizontal ordinate, equilibrium potential reading (mV) are as ordinate carries out linear regression, obtains typical curve equation: y=1939.4x-122.07(R
2=0.9965).
The mensuration of Metformin hydrochloride tablet content: Metformin hydrochloride tablet (the 0.25g/ sheet of getting 10 different batches, Tianjin Pacific Pharmaceutical Co., Ltd.) grind respectively, take the abrasive material that weight is 3.3218g, in 20ml deionized water, with very opening up the ultrasonic 20min of QT2060 Ultrasound Instrument (Tianjin Rui Pu Electronic Instrument, Limited), filter, again by residue in 20ml deionized water, with after the ultrasonic 20min of Ultrasound Instrument, filtrate is mixed with the ultrasonic filtrate obtaining for the first time, constant volume is in 100ml volumetric flask, more ultrasonic 10min, and it is fully dissolved.Then when setting up with typical curve, under identical experiment condition, measure, by the above-mentioned typical curve equation of equilibrium potential value substitution reading, calculate the content of Metformin hydrochloride in tablet, result is as shown in table 1.
Table 1 medicine Metformin hydrochloride assay result
In addition, for further detect measure Metformin hydrochloride tablet accuracy, the present invention has done recovery experiment, as shown in table 2.
Table 2 metformin hydrochloride tablet determination of recovery rates
The recovery is 92.97%～96.28% as seen from Table 2, and result is satisfied.
The above results shows, compare with classic method, not only experimental apparatus is simple in the present invention, testing cost is low, and easy, quick, measurement result relatively accurately, the range of linearity is wider, sensitivity is higher, is simple and easy, the most feasible a kind of analytical approach of measuring metformin hydrochloride tablet.
Claims (3)
1. a new method of measuring Metformin hydrochloride content, is characterized in that, adopting chlorion to select electrode is that working electrode, saturated calomel electrode are contrast electrode, and application potentiometry is measured the content of Metformin hydrochloride effective ingredient.
2. method according to claim 1, is characterized in that, described condition determination is: stir speed (S.S.) 120rpm/min, mixing time are 3 min, and 18 ℃ of temperature be take potassium nitrate and sodium citrate as total ionic strength adjustment buffer degree adjusting buffer solution, and its pH scope is 4～6.
3. method according to claim 1 and 2, is characterized in that, described method is carried out quantitative test with employing calibration curve method to sample, and for measuring the content of the Metformin hydrochloride effective constituent of Metformin hydrochloride medicine.
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| CN201310572565.2A CN103698370A (en) | 2013-11-17 | 2013-11-17 | New metformin hydrochloride detection method |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105277705A (en) * | 2014-07-24 | 2016-01-27 | 江苏维赛科技生物发展有限公司 | Preparation method and detection method for biguanide drug residue detection kit |
| CN106596663A (en) * | 2016-12-10 | 2017-04-26 | 武汉市农业科学技术研究院农业环境安全检测研究所 | Method for rapidly detecting metformin hydrochloride |
| CN109580873A (en) * | 2018-12-27 | 2019-04-05 | 湖北航天化学技术研究所 | A kind of measuring method of triamido guanidine nitrate purity |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1351257A (en) * | 2001-11-27 | 2002-05-29 | 中国科学院广州化学研究所 | Method for measuring content of Cl element and its burner |
| CN201653968U (en) * | 2010-05-19 | 2010-11-24 | 辽宁省建设科学研究院 | Detector of ion content in concrete |
| CN102914573A (en) * | 2012-10-24 | 2013-02-06 | 大连大学 | Method for measuring content of diphenhydramine hydrochloride |
-
2013
- 2013-11-17 CN CN201310572565.2A patent/CN103698370A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1351257A (en) * | 2001-11-27 | 2002-05-29 | 中国科学院广州化学研究所 | Method for measuring content of Cl element and its burner |
| CN201653968U (en) * | 2010-05-19 | 2010-11-24 | 辽宁省建设科学研究院 | Detector of ion content in concrete |
| CN102914573A (en) * | 2012-10-24 | 2013-02-06 | 大连大学 | Method for measuring content of diphenhydramine hydrochloride |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105277705A (en) * | 2014-07-24 | 2016-01-27 | 江苏维赛科技生物发展有限公司 | Preparation method and detection method for biguanide drug residue detection kit |
| CN106596663A (en) * | 2016-12-10 | 2017-04-26 | 武汉市农业科学技术研究院农业环境安全检测研究所 | Method for rapidly detecting metformin hydrochloride |
| CN106596663B (en) * | 2016-12-10 | 2019-03-26 | 武汉市农业科学技术研究院农业环境安全检测研究所 | A kind of Metformin hydrochloride rapid detection method |
| CN109580873A (en) * | 2018-12-27 | 2019-04-05 | 湖北航天化学技术研究所 | A kind of measuring method of triamido guanidine nitrate purity |
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Application publication date: 20140402 |