CN112710751A - Method for measuring tween 80 content in Xingnaojing injection - Google Patents
Method for measuring tween 80 content in Xingnaojing injection Download PDFInfo
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- CN112710751A CN112710751A CN202011512106.1A CN202011512106A CN112710751A CN 112710751 A CN112710751 A CN 112710751A CN 202011512106 A CN202011512106 A CN 202011512106A CN 112710751 A CN112710751 A CN 112710751A
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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
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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
- G01N30/04—Preparation or injection of sample to be analysed
- G01N30/06—Preparation
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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
- G01N30/26—Conditioning of the fluid carrier; Flow patterns
- G01N30/28—Control of physical parameters of the fluid carrier
- G01N30/30—Control of physical parameters of the fluid carrier of temperature
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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
- G01N30/26—Conditioning of the fluid carrier; Flow patterns
- G01N30/28—Control of physical parameters of the fluid carrier
- G01N30/32—Control of physical parameters of the fluid carrier of pressure or speed
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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
- G01N30/26—Conditioning of the fluid carrier; Flow patterns
- G01N30/28—Control of physical parameters of the fluid carrier
- G01N30/34—Control of physical parameters of the fluid carrier of fluid composition, e.g. gradient
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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
- G01N30/62—Detectors specially adapted therefor
- G01N30/74—Optical detectors
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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
- G01N30/26—Conditioning of the fluid carrier; Flow patterns
- G01N30/28—Control of physical parameters of the fluid carrier
- G01N30/32—Control of physical parameters of the fluid carrier of pressure or speed
- G01N2030/324—Control of physical parameters of the fluid carrier of pressure or speed speed, flow rate
Abstract
The invention discloses a method for measuring the content of Tween 80 in a Xingnaojing injection by HPLC-ELSD, which comprises the following steps: (1) preparation of control solutions: accurately weighing appropriate amount of Tween 80 control, and adding water to obtain solution containing Tween 80 2.5mg per 1 ml; (2) preparing a test solution: precisely measuring 5ml of the product, placing the product in a 10ml measuring flask, and adding water to dilute the product to a scale; (3) injecting the reference solution into a high performance liquid chromatograph and an evaporative light scattering detector, and establishing a Tween 80 standard curve by taking the logarithm of the concentration as a horizontal coordinate and the logarithm of the peak area as a vertical coordinate; (4) and (3) injecting the test solution into a high performance liquid chromatograph and an evaporative light scattering detector for determination to obtain the peak area of the Tween 80, so as to obtain the content of the Tween 80 according to the standard curve.
Description
Technical Field
The invention relates to a method for measuring the content of Tween 80 in a Xingnaojing injection by HPLC-ELSD.
Background
The Xingnaojing injection is based on the bezoar chest functioning pill, retains four medicinal materials of musk, borneol, gardenia and radix curcumae through scientific prescription, is refined into water-soluble injection through modern pharmaceutical technology, has the characteristics of convenient administration, rapid blood brain barrier penetration and rapid effect, solves the difficult problem of difficult administration of the traditional pill and coma patients, and better plays the triple roles of awakening resuscitation, fever reduction and brain protection. The traditional Chinese medicine composition is widely used for treating high fever, coma, cerebrovascular diseases, craniocerebral trauma, encephalitis, acute poisoning, various vertigo symptoms and the like in clinic, and has satisfactory curative effect. In order to solve the problems of solubility and uniformity of the liquid medicine, a certain amount of polysorbate 80 (Tween 80) is added to increase the solubility of the effective components.
With the improvement of the requirements on the product quality, the requirements on the detection of the components in the medicine are also increased, and for this reason, the content of tween 80 in the Xingnaojing injection needs to be measured and the research on the measuring method needs to be carried out. In the prior art, CN201410140478.4 and CN201410004997.8 disclose methods for determining the content of tween 80 in a Xuebijing injection and a compound musk injection by using near infrared spectroscopy.
The SEC-ELSD method is used for determining the content of polysorbate 80 in the traditional Chinese medicine injection and the research literature of the method for determining the content of polysorbate 80 in the traditional Chinese medicine injection is used for determining the content of tween 80 in the traditional Chinese medicine injection by adopting a molecular exclusion chromatography-evaporative light scattering method.
The above method has the disadvantages that: when the near infrared spectrum method is adopted for measurement, a correction model is needed, the operation steps are complex, and the daily detection requirements cannot be met. The size exclusion chromatography-evaporative light scattering method adopts a mobile phase with an ammonium acetate buffer solution to reduce the interaction between a sample and a stationary phase, cannot be used in combination with MS, and is limited in popularization and detection.
Based on the reports in the above documents, the invention improves the molecular exclusion chromatography-evaporative light scattering method to obtain the detection method of the invention.
Disclosure of Invention
The invention aims to provide a method for measuring the content of Tween 80 in a Xingnaojing injection by HPLC-ELSD. The purpose of the invention is realized by the following technical scheme: a method for measuring the Tween 80 content in Xingnaojing injection by HPLC-ELSD comprises the following steps:
(1) preparation of control solutions: adding water into Tween 80 as control to obtain control solution;
(2) preparing a test solution: diluting the product with water to obtain test solution;
(3) injecting the reference solution into a high performance liquid chromatograph and an evaporative light scattering detector, and establishing a Tween 80 standard curve by taking the logarithm of the concentration as a horizontal coordinate and the logarithm of the peak area as a vertical coordinate;
(4) injecting the sample solution to be detected into a high performance liquid chromatograph and an evaporative light scattering detector for determination, and obtaining the content of the Tween 80 according to a standard curve;
the chromatographic conditions of the steps (3) and (4): a chromatographic column: agilent ZORBAX SB-C184.6mm X250 mm X5 μm;
mobile phase: mobile phase A: water; mobile phase B: methanol. Gradient elution;
gradient elution conditions:
flow rate: 1.0 ml/min; column temperature: 30 ℃; sample introduction amount: 10 mu l of the mixture; ELSD parameters: temperature of the drift tube: 98.5 ℃; gas flow rate: 2.7 ml/min; gain parameters: 1.
(5) in the step (1), 25.58mg of Tween 80 reference substance is precisely weighed, placed in a 10ml volumetric flask, diluted to a scale by adding water, and shaken uniformly to obtain a reference substance solution with the concentration of 2.558 mg/ml.
(6) And (2) precisely measuring 5ml of the Xingnaojing injection into a 10ml measuring flask, adding water to dilute the Xingnaojing injection to a scale, shaking up, and filtering with a 0.22 mu m microporous membrane to obtain a test solution.
Compared with the prior art, the invention has the following beneficial effects:
compared with the prior art, the method provided by the invention is simple to operate, uses water as a diluent, and is safe and environment-friendly; the detection is rapid, efficient and time-saving, and the Tween 80 can be separated from other components and measured within 12 min; compared with the detection method of tween 80 in other traditional Chinese medicine injections, the gradient elution is adopted, the interference of other components in the Xingnaojing injection can be removed, chromatographic peaks of a test solution and a reference solution only have a single chromatographic peak of tween 80, substances interfering the measurement are effectively removed, and the accuracy and reliability of the measurement result are ensured.
Compared with the prior art, the invention has the advantages that:
drawings
FIG. 1 blank solution (water) chromatographic peaks;
FIG. 2 HPLC chromatogram of Tween 80 control;
FIG. 3 negative solution (without Tween 80) HPLC chromatogram;
FIG. 4 is an HPLC chromatogram of an optimized proreshment injection;
FIG. 5 is an HPLC chromatogram of Xingnaojing injection according to an embodiment of the present invention.
FIG. 6: tween 80 linearity
Detailed Description
The invention is further explained below with reference to the drawings and the detailed description.
Example 1
A method for measuring Tween 80 content in XINGNAOJING injection comprises preparing test solution, preparing reference solution, and detecting by high performance liquid chromatography-ELSD; the reference solution is methanol solution containing ophiopogonin D' 0.2mg/ml, and the high performance liquid detection conditions are as follows: agilent ZORBAX SB-C184.6mm X250 mm X5 μm; mobile phase: mobile phase A: water; mobile phase B: methanol. Gradient elution;
gradient elution conditions:
flow rate: 1.0 ml/min; column temperature: 30 ℃; sample introduction amount: 10 mu l of the mixture; ELSD parameters: temperature of the drift tube: 98.5 ℃; gas flow rate: 2.7 ml/min; gain parameters: 1.
the best determination method of the test solution comprises the following steps:
control solution: adding water into Tween 80 as control to obtain control solution; test solution: diluting the product with water to obtain test solution; injecting the reference solution into a high performance liquid chromatograph and an evaporative light scattering detector, and establishing a Tween 80 standard curve by taking the logarithm of the concentration as a horizontal coordinate and the logarithm of the peak area as a vertical coordinate; and (3) injecting the sample solution to be detected into a high performance liquid chromatograph and an evaporative light scattering detector for determination, and obtaining the content of the Tween 80 according to a standard curve.
The complete assay procedure is described below with respect to the optimal assay method in connection with the test solution.
1 Instrument and device and reagent
The instrument equipment comprises: see table 1; the reagent and reagent are shown in Table 2.
Table 1: instrumentation and equipment
| Name (R) | Model number | Manufacturer of the product | Device numbering |
| Liquid chromatograph | Agilent1200 ELSD detector | Agilent | FC055 |
| Electronic balance | MS150DU | Mettler | FC070 |
| Ultrapure water machine | Milli-Q | Millipore | GC311 |
| Ultrasonic instrument | KQ-500DB | KUNSHAN ULTRASONIC INSTRUMENTS Co.,Ltd. | FC167 |
Table 2: reagent
2 chromatographic conditions
A chromatographic column: agilent ZORBAX SB-C184.6mm X250 mm X5 μm
Mobile phase: mobile phase A: water (W)
Mobile phase B: methanol
Gradient elution:
a detector: temperature of the drift tube: 98.5 ℃; gas flow rate: 2.7 ml/min; gain parameters: 1
Column temperature: 30 deg.C
Flow rate: 1.0ml/min
Sample introduction amount: 10 μ l
Operating time: 40min
3 preparation of the solutions
Control solution: accurately weighing appropriate amount of Tween 80 control, and adding water to obtain solution containing Tween 80 2.5mg per 1 ml.
Test solution: precisely measuring 5ml of the product, placing into a 10ml measuring flask, and diluting with water to scale.
4 specificity
The formulations of the solutions are shown in Table 3.
Table 3: preparation of Each solution
And (3) determination: precisely measuring 10 μ l of each solution in Table 3, injecting into a liquid chromatograph, and recording chromatogram, wherein the results are shown in Table 4 and accompanying drawings 1-5.
Table 4: result of specialization
| Name (R) | Retention time min | Peak area | Theoretical plate | Degree of separation |
| Control solution | 6.355 | 7.6824 | 1353 | — |
| Test solution | 6.338 | 7.2819 | 1185 | — |
And (4) conclusion: the theoretical plate of Tween 80 peak is greater than 1000, the blank solution and the negative control solution have no interference of impurity peak, the retention time of the control solution and the test solution is consistent, and the peak shape is good, which indicates that the specificity of the method is good.
5 Linear and Range
Accurately weighing 525.27mg of Tween 80 reference substance, placing in a 50ml volumetric flask, adding water to dilute to scale, and using as reference substance mother liquor.
Precisely measuring 1.25ml, 2ml, 2.5ml, 3ml, 3.75ml and 5ml of the control mother liquor respectively, placing the control mother liquor into a 10ml volumetric flask, and adding water to the scales to obtain linear solutions with the concentrations of 1.313mg/ml, 2.101mg/ml, 2.626mg/ml, 3.152mg/ml, 3.940mg/ml and 5.253mg/ml respectively.
Precisely measuring 10 μ l of each solution, injecting into a liquid chromatograph, recording chromatogram, drawing a standard curve by taking the logarithm of concentration as abscissa and the logarithm of peak area as ordinate, and calculating a regression equation and a correlation coefficient, wherein r is not less than 0.999, and the result is shown in Table 5 and FIG. 6.
Table 5: linear result
| Serial number | Concentration mg/ml | Peak area | Logarithm of concentration | Logarithm of peak area |
| 1 | 1.313 | 8.660 | 0.11826 | 0.93752 |
| 2 | 2.101 | 20.542 | 0.32243 | 1.31264 |
| 3 | 2.626 | 31.586 | 0.41929 | 1.49949 |
| 4 | 3.152 | 44.024 | 0.49859 | 1.64369 |
| 5 | 3.940 | 66.402 | 0.59550 | 1.82218 |
| 6 | 5.253 | 111.804 | 0.72041 | 2.04846 |
And (4) conclusion: the regression equation of tween 80 is 1.849x +0.720, and the correlation coefficient r is 1, which meets the specification.
6 precision
6.1 precision of sample introduction
Precisely weighing the Tween 80 reference substance 525.27, placing in a 50ml volumetric flask, adding water to dilute to scale, precisely weighing 2.5ml, placing in a 10ml volumetric flask, adding water to dilute to scale to obtain a reference substance solution.
Precisely measuring 5ml of the product, placing the product in a 10ml measuring flask, and adding water to dilute the product to a scale to obtain a test solution.
Precisely measuring 10 μ l of the solution, injecting into a liquid chromatograph, continuously sampling 6 needles, recording chromatogram, requiring that the retention time RSD is not more than 1.0%, and the peak area RSD is not more than 2.0%, and the result is shown in Table 6.
Table 6: result of sample introduction precision
And (4) conclusion: the retention time RSD of the Tween 80 is not more than 0.1 percent, the peak area RSD is not more than 1.9 percent, and the standard is met.
6.2 repeatability
Precisely measuring 5ml of the product, placing the product in a 10ml measuring flask, adding water to dilute the product to a scale, using the product as a test solution, and preparing 6 parts by the same method.
Precisely measuring 10 μ l of each solution, injecting into a liquid chromatograph, recording chromatogram, and requiring content result RSD not more than 2.0%, the results are shown in Table 7.
Table 7: repetitive results
And (4) conclusion: the result of the content of the Tween 80, RSD, is not more than 1.0 percent and meets the regulation.
6.3 intermediate precision
Precisely measuring 5ml of the product, placing the product in a 10ml measuring flask, adding water to dilute the product to a scale, using the product as a test solution, and preparing 6 parts by the same method.
Precisely measuring 10 μ l of each solution, injecting into a liquid chromatograph, carrying out experiment by changing people, recording chromatogram, and requiring content result RSD not more than 2.0%, the result is shown in Table 8.
Table 8: intermediate precision results
And (4) conclusion: the result of the content of the Tween 80, namely RSD, does not exceed 1.1 percent and meets the regulation.
7 degree of accuracy
The formulations of the solutions are shown in Table 9.
Table 9: preparation of Each solution
And (3) determination: precisely measuring 10 mul of each concentration recovery rate solution in the table 9, injecting the solution into a liquid chromatograph, recording a chromatogram, and requiring the recovery rate to be between 90% and 108% and the RSD not to exceed 3.0%, wherein the results are shown in the table 10.
Table 10: accuracy results
And (4) conclusion: the recovery rate of the Tween 80 is between 101 and 108 percent, and the RSD is 2.1 percent, which meets the regulation.
8 solution stability
Accurately weighing 525.56mg of Tween 80 reference substance, placing in a 50ml volumetric flask, adding water to dilute to a scale, accurately weighing 2.5ml, placing in a 10ml volumetric flask, adding water to dilute to a scale to obtain a reference substance solution.
Precisely measuring 5ml of the product, placing the product in a 10ml measuring flask, and adding water to dilute the product to a scale to obtain a test solution.
Precisely measuring the above solutions at 0h, 2h, 4h, 6h, 12h and 24h respectively to obtain 10 μ l of each solution, injecting into a liquid chromatograph, recording chromatogram, requiring retention time RSD not more than 1.0% and peak area RSD not more than 3.0%, and finding results in Table 11.
Table 11: solution stability results
And (4) conclusion: the retention time is not more than 0.1 percent, the peak area RSD is not more than 2.4 percent, and the stability of the reference solution is good within 24 hours at room temperature and the stability of the test solution is good within 28 hours at room temperature.
9 sample assay
Precisely measuring 5ml of the product, placing the product in a 10ml measuring flask, and adding water to dilute the product to a scale to obtain a test solution. Precisely measuring 10 μ l of the test solution, injecting into a liquid chromatograph, and recording chromatogram, wherein the results are shown in Table 12.
Table 12: results of content determination of three batches of samples
And (4) conclusion: the content results of the three batches of samples are between 4.9mg/ml and 5.0mg/ml, and the content result RSD is not more than 0.9 percent, which accords with the regulation, and indicates that the method can be used for measuring the content of the Xingnaojing injection Tween 80.
The above-described embodiments of the present invention are to be considered as illustrative and not restrictive, and therefore all slight modifications, equivalent changes and modifications made to the above examples in accordance with the spirit of the present invention are within the scope of the present invention.
Claims (3)
1. A method for measuring the Tween 80 content in a Xingnaojing injection by an HPLC-ELSD method is characterized by comprising the following steps:
(1) preparation of control solutions: adding water into Tween 80 as control to obtain control solution;
(2) preparing a test solution: adding water into the Xingnaojing injection to prepare a test solution;
(3) injecting the reference solution into a high performance liquid chromatograph and an evaporative light scattering detector, and establishing a Tween 80 standard curve by taking the logarithm of the concentration as a horizontal coordinate and the logarithm of the peak area as a vertical coordinate;
(4) injecting the test solution into a high performance liquid chromatograph and an evaporative light scattering detector for measurement, and obtaining the content of Tween 80 according to a standard curve;
the chromatographic conditions of the steps (3) and (4):
a chromatographic column: agilent ZORBAX SB-C184.6mm X250 mm X5 μm;
mobile phase: mobile phase A: water; mobile phase B: methanol;
gradient elution conditions:
flow rate: 1.0 ml/min; column temperature: 30 ℃; sample introduction amount: 10 mu l of the mixture; ELSD parameters: temperature of the drift tube: 98.5 ℃; gas flow rate: 2.7 ml/min; gain parameters: 1.
2. the method for determining the content of tween 80 in the Xingnaojing injection by HPLC-ELSD as claimed in claim 1, wherein in the step (1), 25.58mg of tween 80 control is precisely weighed, placed in a 10ml volumetric flask, diluted to the scale by adding water, and shaken up to obtain the control solution with the concentration of 2.558 mg/ml.
3. The HPLC-ELSD method for determining the Tween 80 content in the Xingnaojing injection as claimed in claim 1, wherein in the step (2), 5ml of Xingnaojing injection is precisely measured and placed in a 10ml measuring flask, water is added for dilution to a scale, shaking is carried out uniformly, and the sample solution is obtained by filtering with a 0.22 μm microporous membrane.
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| CN202011512106.1A CN112710751A (en) | 2020-12-19 | 2020-12-19 | Method for measuring tween 80 content in Xingnaojing injection |
| PCT/CN2021/099586 WO2022127051A1 (en) | 2020-12-19 | 2021-06-11 | Method for measuring content of tween 80 in xingnaojing injection |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022127051A1 (en) * | 2020-12-19 | 2022-06-23 | 无锡济煜山禾药业股份有限公司 | Method for measuring content of tween 80 in xingnaojing injection |
| CN115290772A (en) * | 2022-07-18 | 2022-11-04 | 长春圣金诺生物制药有限公司 | Method for detecting polysorbate 80 content in recombinant urate oxidase for injection |
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| US7241586B2 (en) * | 2005-02-17 | 2007-07-10 | Medtronic Minimed, Inc. | Polypeptide formulations and methods for making, using and characterizing them |
| CN107688072B (en) * | 2016-08-05 | 2021-06-29 | 河南天地药业股份有限公司 | Detection method of Xingnaojing injection |
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| CN111208214B (en) * | 2018-11-21 | 2023-06-06 | 江苏众红生物工程创药研究院有限公司 | Method for detecting tween content in pharmaceutical preparation by liquid phase method |
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Cited By (2)
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| WO2022127051A1 (en) * | 2020-12-19 | 2022-06-23 | 无锡济煜山禾药业股份有限公司 | Method for measuring content of tween 80 in xingnaojing injection |
| CN115290772A (en) * | 2022-07-18 | 2022-11-04 | 长春圣金诺生物制药有限公司 | Method for detecting polysorbate 80 content in recombinant urate oxidase for injection |
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Application publication date: 20210427 |