CN116699013A - Method for separating and detecting related impurities in oseltamium phosphate Wei Kou disintegrating tablet - Google Patents

Method for separating and detecting related impurities in oseltamium phosphate Wei Kou disintegrating tablet Download PDF

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Publication number
CN116699013A
CN116699013A CN202310589579.9A CN202310589579A CN116699013A CN 116699013 A CN116699013 A CN 116699013A CN 202310589579 A CN202310589579 A CN 202310589579A CN 116699013 A CN116699013 A CN 116699013A
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impurity
phosphate
solution
impurities
detecting
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Inventor
安明月
赵磊
修勇
高海涛
侯孟祎
戴鑫瑶
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BEIJING SUNHO PHARMACEUTICAL CO LTD
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BEIJING SUNHO PHARMACEUTICAL CO LTD
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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
    • G01N30/04—Preparation or injection of sample to be analysed
    • G01N30/06—Preparation
    • 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
    • G01N30/14—Preparation by elimination of some components
    • 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
    • Y02P20/00—Technologies relating to chemical industry
    • Y02P20/50—Improvements relating to the production of bulk chemicals
    • Y02P20/55—Design of synthesis routes, e.g. reducing the use of auxiliary or protecting groups

Abstract

The application relates to the field of analytical chemistry, in particular to a method for separating and detecting related impurities in oseltamium phosphate Wei Kou disintegrating tablets. The chromatographic column adopted by the method is prepared by taking octyl silane bonded silica gel as a filler, adopting methanol, acetonitrile and phosphate buffer solution as mobile phases for isocratic elution, separating oseltamivir phosphate and related impurities thereof, and then detecting; the flow rate is 0.9-1.5ml per minute, and the column temperature is 50+ -3 ℃. The application provides a method for separating and measuring related impurities in an oseltamium phosphate Wei Kou disintegrating tablet by a high performance liquid chromatography, which can detect and separate one or more related impurities in the oseltamium phosphate Wei Kou disintegrating tablet at the same time.

Description

Method for separating and detecting related impurities in oseltamium phosphate Wei Kou disintegrating tablet
Technical Field
The application relates to the field of analytical chemistry, in particular to a detection method for separating and detecting related impurities in oseltamium phosphate Wei Kou disintegrating tablets by a high performance liquid chromatography.
Background
Oseltamivir phosphate is a neuraminidase inhibitor for the treatment of avian influenza, influenza a and influenza b. Are marketed in 1999 by the U.S. food and drug administration for the treatment and prevention of influenza. Oseltamium phosphate Wei Huaxue is named (3R, 4R, 5S) -4-acetamido-5-amino-3- (1-ethylpropoxy) -1-cyclohexene-1-carboxylic acid ethyl ester phosphate, and has a molecular formula of C16H28N2 O4.H2 PO4, and a chemical structural formula:
the finished product of the oseltamium phosphate Wei Kou disintegrating tablet can have raw material residues or impurity residues generated in the process preparation, such as 3-hydroxy-4-acetamidobenzoic acid ethyl ester, (3R, 4R, 5S) -4-acetamido-5-amino-3- (1-ethylpropoxy) -1-cyclohexene-1-carboxylic acid and the like, and once the impurities are excessive, the quality of the medicine can be affected, toxicity can be generated, and serious adverse reaction is caused to a human body.
At present, the impurity detection and analysis methods of oseltamivir phosphate and preparations thereof are carried by Chinese pharmacopoeia, USP and EP, but the impurity detection methods of oseltamivir phosphate Wei Kou disintegrating tablets are not covered, only impurities I, II and III in oseltamivir phosphate preparations are detected in Chinese pharmacopoeia, only II, III and V in oseltamivir phosphate preparations are detected in USP, and five related impurities in oseltamivir phosphate preparations cannot be effectively separated and detected.
Therefore, development of an impurity separation detection method with strong specificity is needed, and impurities in the oseltamium phosphate Wei Kou disintegrating tablet can be accurately and sensitively detected in a separation mode, so that the method has important significance for improving the product quality of the oseltamium phosphate Wei Kou disintegrating tablet and improving the medication safety of patients.
Disclosure of Invention
In order to solve the problems, the application provides a separation detection method for impurities in oseltamivir phosphate Wei Kou disintegrating tablets, which meets the measurement requirements of specificity, sensitivity and the like, and can separate and detect five known impurities in oseltamivir phosphate Wei Kou disintegrating tablets, thereby effectively controlling the quality of oseltamivir phosphate disintegrating tablets and reducing the harm to human bodies.
The application aims at providing a method for separating related impurities in oseltamivir phosphate Wei Kou disintegrating tablets, which can effectively separate oseltamivir phosphate and five related impurities thereof, and adopts the following technical scheme:
the method for separating oseltamivir phosphate and related impurities in the oseltamivir phosphate Wei Kou disintegrating tablet by using a high performance liquid chromatography method comprises the steps of adopting a chromatographic column to perform isocratic elution by using octyl silane bonded silica gel as a filler and adopting a mobile phase to separate oseltamivir phosphate and related impurities; the related impurities include one or more of impurities I-V; the impurity I-V is (3R, 4R, 5S) -4-acetamido-5-amino-3- (1-ethylpropoxy) cyclohex-1-ene-1-carboxylic acid methyl ester phosphate, 3-hydroxy-4-acetamidobenzoic acid ethyl ester, (3R, 4R, 5S) -4-acetamido-5-amino-3- (1-ethylpropoxy) -1-cyclohexene-1-carboxylic acid, (3R, 4R, 5S) -5-acetamido-4-amino-3- (1-ethylpropoxy) cyclohex-1-ene-1-carboxylic acid, and (3R, 4R, 5S) -5-acetamido-4-amino-3- (1-ethylpropoxy) cyclohex-1-ene-1-carboxylic acid ethyl ester; the related impurity has the following structural formula:
the mobile phase is methanol, acetonitrile and phosphate buffer solution;
further, the volume ratio of the methanol to the acetonitrile to the phosphate buffer solution in the mobile phase is 20-30:9-18:59-69;
preferably, the volume ratio of the methanol, the acetonitrile and the phosphate buffer solution in the mobile phase is 24:13:64;
preferably, the phosphate buffer solution in the mobile phase is a 0.68% potassium dihydrogen phosphate buffer salt solution;
the flow rate of the mobile phase is 0.9-1.5ml/min; preferably 1.2ml/min;
further, the octyl silane bonded silica gel is Waters symmetry C;
further, the column temperature of the method is 50+/-3 ℃;
preferably, the column temperature of the process is 50 ℃.
According to a second aspect of the application, a method for detecting related impurities in an oseltamium phosphate Wei Kou disintegrating tablet by high performance liquid chromatography is provided, and the method can effectively detect the related impurities in the oseltamium phosphate Wei Kou disintegrating tablet, and adopts the following technical scheme steps:
1. preparing a solution to be tested by using a diluent, wherein the solution to be tested comprises: a sample solution, a control solution and an impurity control solution;
2. detecting the content of oseltamivir phosphate and various impurities in the solution to be detected in the step 1 by adopting a liquid chromatography system;
3. according to the detected chromatogram, the content of oseltamivir phosphate and related impurities in the sample solution is calculated according to an external standard method and the peak area.
Preferably, the preparation steps of the impurity reference substance solution in the step 1 specifically include: and respectively and precisely weighing the reference substances of the impurity I, the impurity II, the impurity III, the impurity IV and the impurity V, and quantitatively diluting with water to prepare a mixed solution containing 2.2 mug of the impurity I, 1.5 mug of the impurity II, 3.5 mug of the impurity III, 5 mug of the impurity IV and 5 mug of the impurity V in each 1ml serving as a reference substance solution.
Preferably, the preparation steps of the sample solution in step 1 specifically include: taking a proper amount of oseltamivir phosphate Wei Kou disintegrating tablet, placing the tablet into a measuring flask, and adding a diluent to prepare a solution containing 1mg of oseltamivir phosphate in each 1 ml.
Preferably, the preparation step of the control solution in step 1 specifically comprises the following steps: precisely measuring 1ml of sample solution, placing into a 100ml measuring flask, adding diluent to scale, shaking, precisely measuring 1ml, placing into a 10ml measuring flask, adding diluent to scale, shaking, filtering, and collecting filtrate as control solution.
Preferably, the diluent in step 1 is water.
The application has the beneficial effects that:
1) The method for separating and detecting the relevant impurities in the oseltamium phosphate Wei Kou disintegrating tablet by using the high performance liquid chromatography can simultaneously separate and detect one or more relevant impurities, and compared with the prior art, the method has the advantages that the separation and detection efficiency is improved;
2) The method for detecting the related impurities in the oseltamium phosphate Wei Kou disintegrating tablet can effectively separate the known impurities which are difficult to separate, and has good specificity.
Drawings
In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present application, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.
FIG. 1 is a chromatogram of an impurity control solution;
FIG. 2 is a chromatogram of an impurity I localization solution;
FIG. 3 is a chromatogram of an impurity II localization solution;
FIG. 4 is a chromatogram of an impurity III localization solution;
FIG. 5 is a chromatogram of an impurity IV localization solution;
FIG. 6 is a chromatogram of an impurity V localization solution;
FIG. 7 is a chromatogram of an oseltamium phosphate Wei Kou disintegrating tablet sample (test article) solution;
FIG. 8 is a chromatogram of an impurity I-IV quantitative limiting solution;
FIG. 9 is a chromatogram of an impurity V quantitative limiting solution;
Detailed Description
It should be noted that the following detailed description is illustrative and is intended to provide further explanation of the application. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs.
The technical solutions of the present application will be clearly and completely described below in connection with specific embodiments, and it is apparent that the described embodiments are some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.
Example 1
Chromatographic conditions:
the elution was carried out with octyl silane bonded silica as packing (Waters symmetry C) and methanol-acetonitrile-phosphate buffer (24:13:64) as mobile phase. The detection wavelength was 207nm, the flow rate was 1.2ml/min, and the column temperature was 50 ℃.
Example 2
The application provides a method specificity test:
1. reagent configuration:
blank solution: and (3) water.
Impurity control stock: accurately weighing the right amount of the reference substances of the impurity I, the impurity II, the impurity III, the impurity IV and the impurity V, accurately weighing, adding water for quantitative dilution, and preparing a solution containing 22 mug of the impurity I, 15 mug of the impurity II, 35 mug of the impurity III, 50 mug of the impurity IV and 50 mug of the impurity V per 1 ml.
Oseltamivir phosphate stock: accurately weighing oseltamivir phosphate reference substance about 20mg in a 10ml measuring flask, adding water for quantitative dilution to scale, and shaking uniformly to obtain oseltamivir phosphate stock solution.
Mixing solution: 1ml of reference stock solution of the impurities I, II, III, IV and V and 5ml of oseltamivir phosphate stock solution are respectively measured precisely, placed in a 10ml measuring flask, and quantitatively diluted by adding water to prepare a mixed solution containing 2.2 mug of the impurities I, 1.5 mug of the impurities II, 3.5 mug of the impurities III, 5 mug of the impurities IV, 5 mug of the impurities V and 1mg of oseltamivir phosphate per 1 ml.
Test solution: taking 5 pieces of oseltamium phosphate Wei Kou disintegrating tablet, placing the 5 pieces into a 100ml measuring flask, precisely measuring 5ml, placing the 5ml into a 10ml measuring flask, adding a diluent to dilute to a scale, and shaking uniformly to obtain a sample solution.
Impurity I localization solution: the stock solutions of impurity I were measured in appropriate amounts, and diluted quantitatively with water to prepare a solution containing about 22. Mu.g of impurity I per 1 ml.
Impurity II localization solution: the stock solutions of impurity II were measured in appropriate amounts, and diluted quantitatively with water to prepare a solution containing about 15. Mu.g of impurity II per 1 ml.
Impurity III localization solution: the stock solutions of impurity III were measured in appropriate amounts, and diluted quantitatively with water to prepare a solution containing about 35. Mu.g of impurity III per 1 ml.
Impurity IV localization solution: the stock solutions of impurity IV were measured in appropriate amounts, and diluted quantitatively with water to prepare a solution containing about 50. Mu.g of impurity IV per 1 ml.
Impurity V localization solution: the impurity V stock solutions were measured in appropriate amounts, and diluted quantitatively with water to prepare a solution containing about 50. Mu.g of impurity V per 1 ml.
2. Determination method and results:
15 μl of the above solution was injected into a liquid chromatograph, and a chromatogram was recorded (see FIGS. 1-7) as follows:
TABLE 1 impurity separation and positioning test results
The results show that the minimum separation degree between the impurities and the main component is 1.580, which meets the requirements, and the good separation can be achieved between the impurities and the main component.
The application provides a sensitivity test of a method:
1. reagent configuration:
impurity control stock: and weighing a proper amount of reference substances of the impurities I, II, III, IV and V, precisely weighing, adding water for dissolving and quantitatively diluting to obtain solutions of the impurities I, II, III, IV and V with the concentrations of about 108 mug/ml, 103 mug/ml, 83 mug/ml, 100 mug/ml and 100 mug/ml respectively, and taking the solutions as stock solutions.
Quantitative limiting solution: and gradually diluting the impurity reference substance stock solution to S/N of not less than 10.
2. Determination method and results:
15 μl of the above solution was injected into a liquid chromatograph, and a chromatogram (see FIGS. 8 to 9) was recorded, with the following results:
TABLE 2 quantitative limit test results for known impurities
Example 3
Oseltamium phosphate Wei Kou disintegrating tablet samples (30 mg) were tested by the method provided by the application, and the result shows that the sample solution is chromatographed (figure 7) and table 3.
TABLE 3 detection results of oseltamium phosphate Wei Kou disintegrating tablet sample
Impurity name Impurity I Impurity II Impurity III Impurity IV Impurity V Other single impurities Total impurities
Amount of detection 0.046％ 0.050％ 0.048％ Not detected Not examinedOut of Not detected 0.14％
The solution chromatogram of the oseltamium phosphate Wei Kou disintegrating tablet sample (figure 7) and the results in table 3 show that: the detection amount of the impurity I in the oseltamium phosphate Wei Kou disintegrating tablet sample is 0.046%, the detection amount of the impurity II is 0.050%, the detection amount of the impurity III is 0.048%, the impurities IV and V are not detected, and the oseltamium phosphate Wei Kou disintegrating tablet sample meets the requirements of relevant impurity limits in oseltamium phosphate bulk drugs or capsule preparations carried by Chinese pharmacopoeia, EP and BP.
Finally, it should be noted that: the foregoing is merely a preferred embodiment of the application, and it is to be understood that the application is not limited to the form disclosed herein but is not to be construed as excluding other embodiments, but is capable of numerous other combinations, modifications and environments and is capable of modifications within the scope of the inventive concept, either as taught or as a matter of routine skill or knowledge in the relevant art. And that modifications and variations which do not depart from the spirit and scope of the application are intended to be within the scope of the appended claims.

Claims (9)

1. The impurity separation detection method of the oseltamivir phosphate Wei Kou disintegrating tablet is characterized in that a chromatographic column adopted by the method takes octyl silane bonded silica gel as a filler, a mobile phase is adopted for isocratic elution, the flow rate of the mobile phase is 0.9-1.5ml/min, the column temperature is 50+/-3 ℃, the detection wavelength is 207nm, and oseltamivir phosphate and related impurities thereof are separated; the related impurities include one or more of impurities I-V; the impurity I-V is (3R, 4R, 5S) -4-acetamido-5-amino-3- (1-ethylpropoxy) cyclohex-1-ene-1-carboxylic acid methyl ester phosphate, 3-hydroxy-4-acetamidobenzoic acid ethyl ester, (3R, 4R, 5S) -4-acetamido-5-amino-3- (1-ethylpropoxy) -1-cyclohexene-1-carboxylic acid, (3R, 4R, 5S) -5-acetamido-4-amino-3- (1-ethylpropoxy) cyclohex-1-ene-1-carboxylic acid, and (3R, 4R, 5S) -5-acetamido-4-amino-3- (1-ethylpropoxy) cyclohex-1-ene-1-carboxylic acid ethyl ester; the mobile phase is methanol, acetonitrile and phosphate buffer solution; the related impurity has the following structural formula:
2. the method for separating and detecting impurities according to claim 1, wherein the mobile phase is composed of methanol, acetonitrile and phosphate buffer solution according to a volume ratio of 20-30:9-18:59-69.
3. The method for separating and detecting impurities according to claim 2, wherein the volume ratio of methanol, acetonitrile and phosphate buffer solution in the mobile phase is 24:13:64.
4. The method for separating and detecting impurities according to claim 3, wherein the phosphate buffer solution in the mobile phase is 0.5% -0.75% potassium dihydrogen phosphate buffer salt solution.
5. The method for detecting impurity separation according to claim 1, wherein the flow rate of the mobile phase is 0.9 to 1.5ml/min.
6. The method for separating and detecting impurities according to claim 1, wherein the column temperature is 50.+ -. 3 ℃.
7. The method for detecting impurity separation according to claim 1, comprising the steps of:
s1, preparing a solution to be tested by using a diluent, wherein the solution to be tested comprises the following components: a sample solution, a control solution and an impurity control solution;
s2, detecting the content of oseltamivir phosphate and various impurities in the solution to be detected in the step S1 by adopting a liquid chromatography system;
s3, calculating the content of related impurities in the sample solution according to the detected chromatogram and the peak area by an external standard method.
8. The method for detecting impurity isolation according to claim 7, wherein the step of preparing the impurity control solution in step S1 comprises the steps of: and respectively weighing the reference substances of the impurity I, the impurity II, the impurity III, the impurity IV and the impurity V in proper amounts, adding water for quantitative dilution to prepare a mixed solution containing 2.2 mug of the impurity I, 1.5 mug of the impurity II, 3.5 mug of the impurity III, 5 mug of the impurity IV and 5 mug of the impurity V in each 1 ml.
9. The method for detecting impurity separation according to claim 7, wherein the diluent in step S1 is water.
CN202310589579.9A 2023-05-22 2023-05-22 Method for separating and detecting related impurities in oseltamium phosphate Wei Kou disintegrating tablet Pending CN116699013A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117214369A (en) * 2023-11-09 2023-12-12 山东百诺医药股份有限公司 Liquid chromatography method for detecting related substances of oseltamium phosphate Wei Ganhun suspension

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117214369A (en) * 2023-11-09 2023-12-12 山东百诺医药股份有限公司 Liquid chromatography method for detecting related substances of oseltamium phosphate Wei Ganhun suspension
CN117214369B (en) * 2023-11-09 2024-02-02 山东百诺医药股份有限公司 Liquid chromatography method for detecting related substances of oseltamium phosphate Wei Ganhun suspension

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