CN112255329A - Ion chromatography for determining chloride ions in edetate disodium - Google Patents
Ion chromatography for determining chloride ions in edetate disodium Download PDFInfo
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- CN112255329A CN112255329A CN202010998059.XA CN202010998059A CN112255329A CN 112255329 A CN112255329 A CN 112255329A CN 202010998059 A CN202010998059 A CN 202010998059A CN 112255329 A CN112255329 A CN 112255329A
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- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 title claims abstract description 70
- 238000004255 ion exchange chromatography Methods 0.000 title claims abstract description 32
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 title claims abstract description 31
- 229940124274 edetate disodium Drugs 0.000 title claims abstract description 27
- 239000012085 test solution Substances 0.000 claims abstract description 33
- 238000000034 method Methods 0.000 claims abstract description 22
- 239000012086 standard solution Substances 0.000 claims abstract description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 18
- 239000000243 solution Substances 0.000 claims abstract description 17
- 150000002500 ions Chemical class 0.000 claims abstract description 12
- 238000005303 weighing Methods 0.000 claims abstract description 8
- 238000010812 external standard method Methods 0.000 claims abstract description 6
- 238000004587 chromatography analysis Methods 0.000 claims abstract description 5
- 239000012088 reference solution Substances 0.000 claims abstract description 5
- 238000004458 analytical method Methods 0.000 claims description 14
- HNSDLXPSAYFUHK-UHFFFAOYSA-N 1,4-bis(2-ethylhexyl) sulfosuccinate Chemical compound CCCCC(CC)COC(=O)CC(S(O)(=O)=O)C(=O)OCC(CC)CCCC HNSDLXPSAYFUHK-UHFFFAOYSA-N 0.000 claims description 11
- 238000000926 separation method Methods 0.000 claims description 6
- 239000003112 inhibitor Substances 0.000 claims description 4
- 239000007788 liquid Substances 0.000 claims description 4
- 230000001681 protective effect Effects 0.000 claims description 4
- 239000012487 rinsing solution Substances 0.000 claims 1
- 238000001514 detection method Methods 0.000 abstract description 10
- -1 fluoride ions Chemical class 0.000 abstract description 7
- CPELXLSAUQHCOX-UHFFFAOYSA-M Bromide Chemical compound [Br-] CPELXLSAUQHCOX-UHFFFAOYSA-M 0.000 abstract description 6
- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 abstract description 5
- 239000000126 substance Substances 0.000 abstract description 5
- 238000012360 testing method Methods 0.000 abstract description 4
- 230000035945 sensitivity Effects 0.000 abstract description 2
- 239000003153 chemical reaction reagent Substances 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 3
- 238000006243 chemical reaction Methods 0.000 description 2
- 239000012535 impurity Substances 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 238000001556 precipitation Methods 0.000 description 2
- 229910052709 silver Inorganic materials 0.000 description 2
- 239000004332 silver Substances 0.000 description 2
- SQGYOTSLMSWVJD-UHFFFAOYSA-N silver(1+) nitrate Chemical compound [Ag+].[O-]N(=O)=O SQGYOTSLMSWVJD-UHFFFAOYSA-N 0.000 description 2
- ZAMOUSCENKQFHK-UHFFFAOYSA-N Chlorine atom Chemical compound [Cl] ZAMOUSCENKQFHK-UHFFFAOYSA-N 0.000 description 1
- KRHYYFGTRYWZRS-UHFFFAOYSA-M Fluoride anion Chemical compound [F-] KRHYYFGTRYWZRS-UHFFFAOYSA-M 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 229940006460 bromide ion Drugs 0.000 description 1
- 229910052801 chlorine Inorganic materials 0.000 description 1
- 239000000460 chlorine Substances 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000003480 eluent Substances 0.000 description 1
- 229910052736 halogen Inorganic materials 0.000 description 1
- 150000002367 halogens Chemical class 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000002386 leaching Methods 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000000575 pesticide Substances 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 229910001961 silver nitrate Inorganic materials 0.000 description 1
- 238000004879 turbidimetry Methods 0.000 description 1
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/62—Detectors specially adapted therefor
- G01N30/64—Electrical detectors
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/96—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation using ion-exchange
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
- G01N2030/042—Standards
- G01N2030/047—Standards external
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/62—Detectors specially adapted therefor
- G01N30/64—Electrical detectors
- G01N2030/645—Electrical detectors electrical conductivity detectors
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/96—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation using ion-exchange
- G01N2030/965—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation using ion-exchange suppressor columns
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
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- Investigating Or Analyzing Materials By The Use Of Electric Means (AREA)
Abstract
The invention discloses an ion chromatography method for determining chloride ions in edetate disodium, which comprises the following steps: s1, preparing a test solution: precisely weighing an edetate disodium sample, placing the edetate disodium sample in a volumetric flask, and adding water to a constant volume for later use; s2, preparing a control solution: precisely transferring the chloride ion standard solution, placing the chloride ion standard solution into a volumetric flask, and adding water to a constant volume for later use; s3, ion chromatography determination: and respectively and directly feeding the test solution and the reference solution into an ion chromatograph, carrying out chromatographic analysis, respectively calculating peak areas, and calculating the content of chloride ions in the test solution according to a single-point external standard method. The method judges whether chloride ions in the test solution exceed the standard or not through ion chromatography specificity, and distinguishes the chloride ions from other ions causing chemical method turbid results, such as fluoride ions, sulfate ions and bromide ions; the pretreatment process of the test solution is simplified, and the sample is directly injected after being dissolved by adding water; meanwhile, the sample volume of the test sample is obviously reduced, and the detection sensitivity is improved.
Description
Technical Field
The invention relates to the technical field of a detection method of halogen elements, in particular to an ion chromatography for detecting chloride ions in edetate disodium.
Background
Edetate disodium is commonly used as a raw material in the production of pharmaceuticals and pesticides. The existence of chloride ions as impurity ions in the disodium edetate reagent can affect the performance and equipment safety of products, and the disodium edetate reagent can use chlorine-containing substances in the production process and has the possibility of chloride ion impurity residues, so that the detection of the chloride ions in the high-purity disodium edetate reagent becomes a necessary link in the production process.
The existing common method for detecting chloride ions, namely a chemical turbidimetry method, has the following disadvantages: 1. under the condition of an acid environment, silver ions in a silver nitrate test solution and chloride ions in a test solution are subjected to a precipitation reaction, so that the solution is easy to be turbid, and the method cannot specifically distinguish the reasons of the turbidity of the test solution, for example, the chloride ions, sulfate radicals, fluoride ions and bromide ions in the test solution can cause the silver ions to be subjected to a white or off-white precipitation reaction; 2. the pretreatment is complicated, and sometimes the test solution needs to be filtered; 3. the sample sampling amount needs 1.0g, and the method is not suitable for testing trace samples; 4. the detection is not sensitive enough.
Disclosure of Invention
The invention aims to provide an ion chromatography for determining chloride ions in edetate disodium, aiming at the defects in the prior art.
In order to achieve the purpose, the invention adopts the technical scheme that:
provides an ion chromatography method for detecting chloride ions in edetate disodium, which comprises the following steps:
s1, preparing a test solution: precisely weighing an edetate disodium sample, placing the edetate disodium sample in a volumetric flask, and adding water to a constant volume for later use;
s2, preparing a control solution: precisely transferring the chloride ion standard solution, placing the chloride ion standard solution into a volumetric flask, and adding water to a constant volume for later use;
s3, ion chromatography determination: directly feeding the test solution and the reference solution into an ion chromatograph, performing chromatographic analysis, calculating peak areas respectively, and calculating the content of chloride ions in the test solution according to a single-point external standard method;
wherein the ion chromatography analysis conditions comprise:
using a Thermo ICS-1100 ion chromatograph, Chromeleon7.2.8 chromatographic workstation, Dionex IonPacTMAG18 (4X 250mm) column, Dionex IonPacTMAS18 (4X 50mm) protective column, ADRS6004mm inhibitor, conductivity detector, leacheate Dionex EGC III KOH RFICTM；
The analysis time is 100min, and the method comprises three stages: in the time period of 0-2min, the initial leacheate concentration is 15mM and is kept for 2 min; increasing the concentration of the leacheate from 15mM to 100mM within a time period of 2-87 min; the concentration of the leacheate was instantaneously reduced from 100mM to 15mM and maintained for 13min over a period of 87-100 min.
Preferably, in S1, the specific process of preparing the test solution is as follows: weighing 40.00mg of the sample, placing the sample in a 100mL volumetric flask, and adding water to a constant volume for later use.
Preferably, in S2, the mass concentration of the chloride ion standard solution is 10 μ g/mL.
Preferably, in S2, the specific process of preparing the control solution is as follows: and transferring 160 mu L of the chloride ion standard solution, placing the chloride ion standard solution into a 100mL volumetric flask, and adding water to a constant volume for later use.
Preferably, in S3, the flow rate of the leaching solution is 1.0mL/min within a time period of 0-15 min; and the flow rate of the rinsing liquid is 1.5mL/min within a time period of 15-100 min.
Preferably, in S3, the ion chromatography analysis conditions further include: the amount of sample was 25. mu.L.
Preferably, in S3, the ion chromatography analysis conditions further include: the column temperature of the separation column is 30 ℃, and the column temperature of the protection column is 30 ℃; the operating temperature of the conductivity detector was 35 ℃.
By adopting the technical scheme, compared with the prior art, the invention has the following technical effects:
the method judges whether chloride ions in the test solution exceed the standard or not through ion chromatography specificity, and distinguishes the chloride ions from other ions causing chemical method turbid results, such as fluoride ions, sulfate ions and bromide ions; the pretreatment process of the test solution is simplified, and the sample is directly injected after being dissolved by adding water; meanwhile, the sample volume of a sample to be tested is obviously reduced by only 40mg, compared with the prior art, the use amount is reduced by 60 percent, the detection sensitivity is improved, the detection limit can reach 10 mu g/L in the solution, and the detection limit in the sample can reach 0.00025 percent.
Drawings
FIG. 1 is a chromatogram for separating chloride ions from fluoride ions, bromide ions and sulfate ions in disodium edetate according to the present invention.
Detailed Description
The invention is further described with reference to the following drawings and specific examples, which are not intended to be limiting.
It should be noted that the embodiments and features of the embodiments may be combined with each other without conflict.
Materials, reagents and the like used in the following examples are commercially available from public unless otherwise specified.
As shown in figure 1, the invention provides an ion chromatography method for determining chloride ions in edetate disodium, which comprises the following steps:
s1, preparing a test solution: precisely weighing an edetate disodium sample, placing the edetate disodium sample in a volumetric flask, and adding water to a constant volume for later use;
s2, preparing a control solution: precisely transferring the chloride ion standard solution, placing the chloride ion standard solution into a volumetric flask, and adding water to a constant volume for later use;
s3, ion chromatography determination: directly feeding the test solution and the reference solution into an ion chromatograph, performing chromatographic analysis, calculating peak areas respectively, and calculating the content of chloride ions in the test solution according to a single-point external standard method;
wherein the ion chromatography analysis conditions comprise:
using a Thermo ICS-1100 ion chromatograph, Chromeleon7.2.8 chromatographic workstation, Dionex IonPacTMAG18 (4X 250mm) column, Dionex IonPacTMAS18 (4X 50mm) protective column, ADRS6004mm inhibitor, conductivity detector, eluentDionex EGCⅢKOH RFICTM；
The analysis time is 100min, and the method comprises three stages: in the time period of 0-2min, the initial leacheate concentration is 15mM and is kept for 2 min; increasing the concentration of the leacheate from 15mM to 100mM within a time period of 2-87 min; the concentration of the leacheate was instantaneously reduced from 100mM to 15mM and maintained for 13min over a period of 87-100 min.
As a preferred embodiment, in S1, the specific process of preparing the test solution is as follows: weighing 40.00mg of the sample, placing the sample in a 100mL volumetric flask, and adding water to a constant volume for later use.
As a preferred embodiment, in S2, the mass concentration of the chloride ion standard solution is 10 mug/mL; the specific process of preparing the reference solution comprises the following steps: and transferring 160 mu L of the chloride ion standard solution, placing the chloride ion standard solution into a 100mL volumetric flask, and adding water to a constant volume for later use.
As a preferred embodiment, in S3, the flow rate of the rinsing liquid is 1.0mL/min within a time period of 0-15 min; and the flow rate of the rinsing liquid is 1.5mL/min within a time period of 15-100 min.
As a preferred embodiment, in S3, the ion chromatography analysis conditions further include: the amount of sample was 25. mu.L.
As a preferred embodiment, in S3, the ion chromatography analysis conditions further include: the column temperature of the separation column is 35 ℃, and the column temperature of the protection column is 35 ℃; the operating temperature of the conductivity detector was 30 ℃.
The specific analysis process for measuring the content of the chloride ions in the test solution is as follows:
comparing whether the area of the peak of the chloride ion peak in the test solution is larger than that of the peak of the chloride ion peak in the contrast solution or not according to the obtained ion chromatograms of the test solution and the contrast solution, and if the area of the chloride ion peak in the test solution is smaller than or equal to that of the chloride ion peak in the contrast solution, indicating that the chloride ion in the test solution is not more than 0.004%; if the area of the chloride ion peak in the test solution is larger than that of the chloride ion peak in the control solution and is not more than 2 times of that of the chloride ion peak, calculating the content (%) of the chloride ion in the test sample according to a single-point external standard method; if the area of the chloride ion peak in the test solution is larger than that of the chloride ion peak in the control solution by more than 2 times, the control solution is prepared again, the area of the chloride ion peak is in the range of 0.5-2 times of that of the test solution, and then the content (%) of the chloride ion in the test sample is calculated according to a single-point external standard method.
Example 1
An ion chromatography method for detecting chloride ions in edetate disodium comprises the following steps:
s1, preparing a test solution: weighing 40.00mg of edetate disodium serving as a medicinal auxiliary material, placing the edetate disodium in a 100mL volumetric flask, and adding water to a constant volume for later use;
s2, preparing a control solution: 160 mu L (10 mu g/mL) of chloride ion standard solution is transferred and placed in a 100mL volumetric flask, and water is added for constant volume for standby;
s3, measurement by ion chromatography: the chromatographic conditions of the ion chromatography are as follows: thermo ICS-1100 type ion chromatograph, Chromeleon7.2.8 chromatography workstation, Dionex IonPacTMAG18 (4X 250mm) column, Dionex IonPacTMAS18 (4X 50mm) protective column, ADRS6004mm inhibitor, conductivity detector, leacheate Dionex EGC III KOH RFICTMFlow rate of the eluent: 1.0mL/min (0-15min), 1.5mL/min (15-100min), an analysis time of 100min, comprising three stages: in the time period of 0-2min, the initial leacheate concentration is 15mM and is kept for 2 min; increasing the concentration of the leacheate from 15mM to 100mM within a time period of 2-87 min; instantly reducing the concentration of the leacheate from 100mM to 15mM and keeping the concentration for 13min within a time period of 87-100min, wherein the sample injection amount is 25 mu L, the column temperature of the separation column is 35 ℃, and the column temperature of the protection column is 35 ℃; the working temperature of the conductivity detector is 30 ℃;
the number of theoretical plates of chloride ions in this example was 6900; the chloride ions, the fluoride ions, the bromide ions and the sulfate ions have good separation degree; the degrees of separation were respectively: fluorine ion: 7.4, chloride ion: 13.3, sulfate ion: 2.4, bromide ion: 24.3; the detection limit of the chloride ion solution can reach 10 mu g/L, and the detection limit in the sample can reach 0.00025%; furthermore, the chloride ion reproducibility RSD was 0.5%; the chloride ion concentration C (ppb) is in the range of 10-500 mug/L, and has good linearity with the peak area A, the linear correlation coefficient r is 0.9999, and the linear equation is C is 4216.1344 xA-1.1705.
Under the item of edetate disodium recorded in the four parts of the Chinese pharmacopoeia 2015 edition, the method is particularly suitable for the situation that the chemical method detection result of chloride ions cannot be effectively confirmed, and under the condition of interference, whether the chloride ions are in the concentration can be further confirmed by the method.
While the invention has been described with reference to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention.
Claims (7)
1. An ion chromatography method for detecting chloride ions in edetate disodium is characterized by comprising the following steps:
s1, preparing a test solution: precisely weighing an edetate disodium sample, placing the edetate disodium sample in a volumetric flask, and adding water to a constant volume for later use;
s2, preparing a control solution: precisely transferring the chloride ion standard solution, placing the chloride ion standard solution into a volumetric flask, and adding water to a constant volume for later use;
s3, ion chromatography determination: directly feeding the test solution and the reference solution into an ion chromatograph, performing chromatographic analysis, calculating peak areas respectively, and calculating the content of chloride ions in the test solution according to a single-point external standard method;
wherein the ion chromatography analysis conditions comprise:
using a Thermo ICS-1100 ion chromatograph, Chromeleon7.2.8 chromatographic workstation, Dionex IonPacTMAG18 (4X 250mm) column, Dionex IonPacTMAS18 (4X 50mm) protective column, ADRS6004mm inhibitor, conductivity detector, leacheate Dionex EGC III KOH RFICTM；
The analysis time is 100min, and the method comprises three stages: in the time period of 0-2min, the initial leacheate concentration is 15mM and is kept for 2 min; increasing the concentration of the leacheate from 15mM to 100mM within a time period of 2-87 min; the concentration of the leacheate was instantaneously reduced from 100mM to 15mM and maintained for 13min over a period of 87-100 min.
2. The ion chromatography method for detecting chloride ions in edetate disodium as claimed in claim 1, wherein the specific process of preparing the test solution in S1 is as follows: weighing 40.00mg of the sample, placing the sample in a 100mL volumetric flask, and adding water to a constant volume for later use.
3. The ion chromatography method for detecting chloride ions in edetate disodium as claimed in claim 1, wherein the mass concentration of the chloride ion standard solution in S2 is 10 μ g/mL.
4. The ion chromatography method for detecting chloride ions in edetate disodium as claimed in claim 3, wherein the control solution is prepared by the following steps in S2: and transferring 160 mu L of the chloride ion standard solution, placing the chloride ion standard solution into a 100mL volumetric flask, and adding water to a constant volume for later use.
5. The ion chromatography method for detecting chloride ions in edetate disodium as claimed in claim 1, wherein in S3, the flow rate of the rinsing solution is 1.0mL/min within 0-15 min; and the flow rate of the rinsing liquid is 1.5mL/min within a time period of 15-100 min.
6. The ion chromatography method for the determination of chloride ion in edetate disodium of claim 1, wherein in S3, the analysis conditions of the ion chromatography method further comprise: the amount of sample was 25. mu.L.
7. The ion chromatography method for the determination of chloride ion in edetate disodium of claim 1, wherein in S3, the analysis conditions of the ion chromatography method further comprise: the column temperature of the separation column is 35 ℃, and the column temperature of the protection column is 35 ℃; the operating temperature of the conductivity detector was 30 ℃.
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| CN108956815A (en) * | 2018-07-05 | 2018-12-07 | 科之杰新材料集团有限公司 | The test method of chloride ion content in a kind of sea sand |
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