CN110308222A - A kind of related substance detecting method of carbetocin bulk pharmaceutical chemicals - Google Patents

A kind of related substance detecting method of carbetocin bulk pharmaceutical chemicals Download PDF

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Publication number
CN110308222A
CN110308222A CN201910643080.5A CN201910643080A CN110308222A CN 110308222 A CN110308222 A CN 110308222A CN 201910643080 A CN201910643080 A CN 201910643080A CN 110308222 A CN110308222 A CN 110308222A
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solution
acetonitrile
carbetocin
detection method
preparation
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徐刚
刘大鹏
刘早霞
赵秀林
崔宏琴
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Wuhan Saiwo Medical Technology Co Ltd
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Wuhan Saiwo Medical Technology Co Ltd
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/04Preparation or injection of sample to be analysed
    • G01N30/06Preparation
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/26Conditioning of the fluid carrier; Flow patterns
    • G01N30/28Control of physical parameters of the fluid carrier
    • G01N30/34Control of physical parameters of the fluid carrier of fluid composition, e.g. gradient
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/62Detectors specially adapted therefor
    • G01N30/74Optical detectors

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  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

The invention belongs to pharmaceutical technology fields, are related to a kind of carbetocin bulk pharmaceutical chemicals Related substance method.Carbetocin bulk pharmaceutical chemicals Related substance method of the present invention, comprising the following steps: step 1: taking carbetocin bulk pharmaceutical chemicals and impurity reference substance each appropriate, and system suitability solution and test solution is made with the dilution of 20% acetonitrile solution;Step 2: using phenyl bonded silica as chromatographic column filler, using UV detector, selecting acetonitrile and buffer is mobile phase, gradient elution;Detection wavelength is 220nm;Flow velocity is 1.0ml/min;Sampling volume is 20 μ l;Column temperature is 35 ~ 40 DEG C.This method efficiently solves the problems, such as the related substance detection of carbetocin bulk pharmaceutical chemicals and separation, and specificity is strong, reproducible, accuracy is high, can guarantee the controllability in carbetocin bulk pharmaceutical chemicals in relation to substance, improves product quality.

Description

A kind of related substance detecting method of carbetocin bulk pharmaceutical chemicals
Technical field
The invention belongs to pharmaceutical technology fields, are related to a kind of analyzing detecting method of active peptides raw material medicine, especially relate to And the related substance detecting method of carbetocin bulk pharmaceutical chemicals.
Background technique
Carbetocin (Carbetocin), its chemical name is: deammoniation -2- oxygen-methyl-tyrosine -1- κ oxytocin, point Minor: C45H69N11O12S, molecular weight 988.17.
Its structural formula:
Carbetocin is a kind of long-acting oxytocins nonapeptide analog with agonist characteristics of synthesis.Under Epidural cavity or lumbar anesthesia It Single-dose intravenous can be administered immediately after caesarean section, to prevent uterus tension deficiency and postpartum haemorrhage.
The clinic and pharmacological property of carbetocin are with naturally-produced oxytocins similar, can urge with uterine smooth muscle It produces plain receptor to combine, causes the Rythmic contractions characteristic in uterus, on the basis of original contraction, increase its frequency and increase uterus Power.Under non pregnant state, the ocytocin receptor content in uterus is very low, during gestation increases, and peak is reached when childbirth.Therefore block Shellfish oxytocin does not act on non-pregnant uterus, but uterus to gestation and the just uterus that produces are with effective uterus receipts Contracting effect.
Studies have shown that give carbetocin 100 micro- for Single-dose intravenous immediately after caesarean section under Epidural cavity or lumbar anesthesia Gram, in prevention uterus tension deficiency and in terms of reducing postpartum haemorrhage, carbetocin is substantially better than placebo.
Carbetocin can be mingled with plurality of impurities, the detailed feelings of impurity in bulk pharmaceutical chemicals using polypeptide solid-state reaction method Condition is as follows:
Above-mentioned impurity influences whether the quality of carbetocin, it is therefore necessary to content control is carried out to impurity, currently, amino acid Analysis mostly use high performance liquid chromatography (HPLC), but it is accurate to the analysis result of different aminoacids to be different method condition Degree is affected.In Peptide systhesis, in order to preferably control product quality, impurity must accurately be analyzed, existing skill In art, carbetocin impurity analysis is had not been reported.For this purpose, the present invention constructs a kind of dividing for related substance of carbetocin Analysis method, this method specificity is strong, precision is good, and accuracy is high, can will likely degradation impurity and process impurity and principal component It effectively separates, and high sensitivity, can be applied to the quality control of carbetocin bulk pharmaceutical chemicals, to raising carbetocin product matter It measures significant.
Summary of the invention
The present invention provides a kind of carbetocin efficient liquid phase detection method, and chromatographic condition is as follows: with phenyl bonded silica It selects acetonitrile using UV detector for chromatographic column filler and buffer is mobile phase, gradient elution;Wherein the gradient is washed De-, mode is as follows: 0~35 minute, it was 20% that acetonitrile, which elutes ratio,;35~50 minutes, acetonitrile eluted ratio 20% ~ 50%;50 ~55 minutes, it was 50% that acetonitrile, which elutes ratio,;Detection wavelength is 220nm;Flow velocity is 1.0ml/min;Sampling volume is 20 μ l;Column Temperature is 35 ~ 40 DEG C.
In the above method, the buffer is selected from: sodium hexanesulfonate buffer, sodium heptanesulfonate buffer, preferably heptan Alkyl sulfonic acid sodium buffer.
In the above method, the chromatographic column is selected from Waters XBridge BEH Phenyl 4.6*100mm 5 μ m;Agilent ZORBAX SB-Phenyl 4.6*75mm 3.5μm;Phenomenex Luna Phenyl-Hexyl 4.6* 100mm 3μm。
In the above method, the gradient elution, mode is as follows: 0~35 minute, it was 20% that acetonitrile, which elutes ratio,;35~50 Minute, acetonitrile elutes ratio 20% ~ 50%;50~55 minutes, it was 50% that acetonitrile, which elutes ratio,;Detection wavelength is 220nm;Flow velocity For 1.0ml/min;Sampling volume is 20 μ l;Column temperature is 35 ~ 40 DEG C.
The present invention also provides a kind of related substance detecting methods of carbetocin bulk pharmaceutical chemicals, the method comprises the following steps:
Step 1: the preparation of solution:
The preparation of blank solution: 20% acetonitrile solution (v/v);
The preparation of impurity reference substance solution: it is appropriate to weigh carbetocin impurity, add blank solvent to make to dissolve and dilute be made it is miscellaneous Matter reference substance solution;
The preparation of test solution: it is appropriate to weigh carbetocin, and blank solvent is added to make to dissolve and dilute that test solution is made;
Step 2: the setting of high-efficient liquid phase chromatogram condition:
Using phenyl bonded silica as chromatographic column filler, using UV detector, selecting acetonitrile and buffer is mobile phase, and gradient is washed De-: wherein the gradient elution, mode are as follows:
0~35 minute, it was 20% that acetonitrile, which elutes ratio,;35~50 minutes, acetonitrile eluted ratio 20% ~ 50%;50~55 minutes, It is 50% that acetonitrile, which elutes ratio,;Detection wavelength is 220nm;Flow velocity is 1.0ml/min;Sampling volume is 20 μ l;Column temperature is 35 ~ 40 ℃。
Under above-mentioned chromatographic condition, accurate extraction system applicability solution and each 20 μ l of test solution, injecting chromatograph, Record chromatogram.In the map of system suitability solution, each impurity peaks and carbetocin peak separating degree are all larger than 1.5.
Detection method of the carbetocin bulk pharmaceutical chemicals in relation to substance provided by the invention can effectively detect the contracting of card release shellfish Gong Su and each impurity peaks, and separating degree is both greater than 1.5, good separating effect, method specificity is strong, precision is good, and accuracy is high, and It is simple and easy, it is swift to operate, there is important researching value in terms of bulk pharmaceutical chemicals and quality of the pharmaceutical preparations research.
Detailed description of the invention
Fig. 1: methodology validation blank solvent map
Fig. 2: methodology validation system suitability solution map
Fig. 3: methodology validation detection line solution map
Fig. 4: methodology validation quantitative limit solution map
Fig. 5: 0.2% test sample own control solution map of methodology validation
Fig. 6: methodology validation test solution map
Fig. 7: methodology validation accuracy solution map
Form is again described in further details the contents of the present invention by the following examples, but not that should not be interpreted as the present invention with regard to this Following embodiment is only limitted in above-mentioned subject area.Under the premise of not departing from above-mentioned technology of the invention, according to the common skill in this field The corresponding modification replaced or change that art knowledge and customary means are made, is included in the present invention.
Embodiment one: the selection of chromatographic column
Conclusion: it takes impurity reference substance solution and test solution that mixed solution injection high performance liquid chromatograph is made, obtains chromatography Figure, principal component and rear other impurities separating degree are 1.3, are unable to satisfy test requirements document.
Embodiment two: the selection of chromatographic column
Conclusion: it takes impurity reference substance solution and test solution that mixed solution injection high performance liquid chromatograph is made, obtains chromatography Figure, principal component and rear other impurities separating degree are 1.1, are unable to satisfy test requirements document.
Embodiment three: the selection of chromatographic column
Conclusion: it takes impurity reference substance solution and test solution that mixed solution injection high performance liquid chromatograph is made, obtains chromatography Figure, principal component and rear other impurities separating degree are 1.9, meet test requirements document.
Example IV: the selection of buffer salt
Conclusion: it takes impurity reference substance solution and test solution that mixed solution injection high performance liquid chromatograph is made, obtains chromatography Figure, impurity IMP-03 and IMP-07 points be unable to do without, and principal component and rear other impurities separating degree are 1.4, are unable to satisfy test requirements document.
Embodiment five: the selection of buffer salt
Conclusion: it takes impurity reference substance solution and test solution that mixed solution injection high performance liquid chromatograph is made, obtains chromatography Figure, each impurity can good separation, principal component and rear other impurities separating degree are 1.9, meet test requirements document.
Embodiment six: the selection of column temperature
Conclusion: it takes impurity reference substance solution and test solution that mixed solution injection high performance liquid chromatograph is made, obtains chromatography Figure, each impurity can good separation, principal component and rear other impurities separating degree are 1.5, meet the requirements, but method durability compared with Difference.
Embodiment seven: the selection of column temperature
Conclusion: it takes impurity reference substance solution and test solution that mixed solution injection high performance liquid chromatograph is made, obtains chromatography Figure, each impurity can good separation, principal component and rear other impurities separating degree are 1.9, meet test requirements document.
Embodiment eight: system suitability and specificity are tested
Solution is prepared:
Diluent: 20% acetonitrile solution (v/v)
Impurity stock solution: IMP-01 10.36mg, IMP-02 10.18mg, IMP-03 10.55mg, IMP-04 are weighed respectively 10.49mg, IMP-05 10.82mg, IMP-06 10.29mg, IMP-07 10.17mg are set in 50ml measuring bottle, add 0.1% acetic acid Scale is dissolved and be diluted to, each impurity stock solution is obtained.
Positioning solution: measuring each impurity stock solution 1ml respectively and set in 10ml measuring bottle respectively, diluent is added to be diluted to scale, Solution is positioned as each impurity.
System suitability solution: weighing carbetocin 10.25mg in 10ml measuring bottle, add IMP-01, IMP-02, Each 0.1ml of IMP-03, IMP-04, IMP-05, IMP-06, IMP-07 impurity stock solution adds diluent to dissolve and is diluted to scale, It shakes up, as system suitability solution.
Each component retention time and separating degree:
Conclusion: blank solvent does not interfere the detection of main peak and impurity peaks, and the separating degree of main peak and preceding other impurities peak is all larger than 1.5, system suitability and specificity meet regulation.
Embodiment nine: quantitative limit and detection limit test
Solution is prepared
Diluent: 20% acetonitrile solution (v/v)
Quantitative limit solution: take IMP-01, IMP-02 under system suitability and specificity item, IMP-03, IMP-04, IMP-05, IMP-06 and IMP-07 impurity stock solution adds diluent to be diluted to the solution of each about 0.5 μ g/ml.
Detection limit solution: it measures quantitative limit solution 3ml and sets in 10ml measuring bottle, add diluted to scale, shake up.
Quantitative limit repetitive test result
Conclusion: quantifying for each impurity is limited to 0.05%, and each continuous 6 needle quantitative limit solution peak area RSD of known impurities is respectively less than 10%. Detection is limited to 0.015%, meets regulation.
Embodiment ten: accuracy test
Solution is prepared
Dilution (blank solvent): 20% acetonitrile solution (v/v)
Impurity stock solution: IMP-01 15.24mg, IMP-02 14.35mg, IMP-03 14.15mg, IMP-04 are weighed respectively 15.85mg, IMP-05 18.67mg, IMP-06 16.73mg, IMP-07 14.44mg are set in 50ml measuring bottle, add diluent molten Scale is solved and be diluted to, each impurity stock solution is obtained.
Impurity mixing reference substance stock solution: take IMP-01, IMP-02, IMP-03, IMP-04, IMP-05, IMP-06 and Each 2ml of IMP-07 impurity stock solution, sets in 20ml measuring bottle, and diluent is added and dissolves and be diluted to scale, shakes up to obtain the final product.
Test solution: weighing carbetocin 20.08mg, sets 20ml measuring bottle, adds diluent to dissolve and is diluted to quarter Degree, as test solution.
Reference substance solution: by 500 times of dilution agent of dilution of test solution, as contrast solution (0.2%).
Accuracy solution: weigh carbetocin 20.86mg, 20.67mg, 20.57mg, 20.46mg, 20.88mg, 20.59mg is set respectively in 6 20ml measuring bottles, each that mixing reference substance stock solution 1ml is added, and is dissolved with diluent and is diluted to quarter Degree, shakes up to obtain the final product.
Accuracy test result
Conclusion: 6 parts of accuracy solution measurement results are shown: IMP-01, IMP-02, IMP-03, IMP-04, IMP-05, IMP-06 With the IMP-07 rate of recovery in 90% ~ 108% range, RSD value is respectively less than 5%, and accuracy meets regulation.

Claims (11)

1. a kind of carbetocin efficient liquid phase detection method, which is characterized in that use chromatographic condition as follows: with phenyl bonded silica Glue is chromatographic column filler, using UV detector, selects acetonitrile and buffer is mobile phase, gradient elution;The wherein gradient Elution, mode are as follows: 0~35 minute, it was 20% that acetonitrile, which elutes ratio, and 35~50 minutes, acetonitrile eluted ratio 20% ~ 50%, 50~55 minutes, it was 50% that acetonitrile, which elutes ratio,;Detection wavelength is 220nm;Flow velocity is 1.0ml/min;Sampling volume is 20 μ l;Column temperature is 35 ~ 40 DEG C.
2. detection method according to claim 1, which is characterized in that the buffer is selected from: sodium hexanesulfonate buffering Liquid, sodium heptanesulfonate buffer, preferably sodium heptanesulfonate buffer.
3. detection method according to claim 1, which is characterized in that the chromatographic column be selected from:
Waters XBridge BEH Phenyl 4.6*100mm 5μm;
Agilent ZORBAX SB-Phenyl 4.6*75mm 3.5μm;
Phenomenex Luna Phenyl-Hexyl 4.6*100mm 3μm。
4. detection method according to claim 1, it is characterised in that: the gradient elution mode is 0~35 minute, second It is 20% that nitrile, which elutes ratio,;35~50 minutes, acetonitrile eluted ratio 20% ~ 50%;50~55 minutes, acetonitrile eluted ratio and is 50%.
5. detection method according to claim 1, it is characterised in that: Detection wavelength 220nm.
6. detection method according to claim 1, it is characterised in that: flow velocity 1.0ml/min.
7. detection method according to claim 1, it is characterised in that: sampling volume is 20 μ l.
8. detection method according to claim 1, it is characterised in that: column temperature is 35 ~ 40 DEG C.
9. a kind of efficient liquid phase detection method of carbetocin bulk pharmaceutical chemicals in relation to substance, which comprises the following steps:
Step 1: the preparation of solution:
The preparation of blank solution: 20% acetonitrile solution (v/v);
The preparation of system suitability solution: taking carbetocin bulk pharmaceutical chemicals and impurity reference substance each appropriate, dilute with 20% acetonitrile solution It releases and mixed solution is made, as system suitability solution;
The preparation of test solution: it is appropriate to weigh carbetocin, and blank solvent is added to make to dissolve and dilute that test solution is made;
Step 2: the setting of high-efficient liquid phase chromatogram condition:
Using phenyl bonded silica as chromatographic column filler, using UV detector, selecting acetonitrile and buffer is mobile phase, and gradient is washed De-: wherein the gradient elution, mode are as follows:
0~35 minute, it was 20% that acetonitrile, which elutes ratio,;35~50 minutes, acetonitrile eluted ratio 20% ~ 50%;50~55 minutes, It is 50% that acetonitrile, which elutes ratio,;Detection wavelength is 220nm;Flow velocity is 1.0ml/min;Sampling volume is 20 μ l;Column temperature is 35 ~ 40 ℃。
10. detection method according to claim 9, which is characterized in that the impurity are as follows:
11. detection method according to claim 9, which is characterized in that the preparation of the solution includes following content:
The preparation of blank solution: 20% acetonitrile solution (v/v);
The preparation of impurity reference substance solution: weighing carbetocin impurity, and blank solvent is added to make to dissolve and dilute to be made in every 1ml Solution containing 20 μ g, as impurity reference substance solution;
The preparation of system suitability solution: taking carbetocin bulk pharmaceutical chemicals and impurity reference substance each appropriate, dilute with 20% acetonitrile solution It releases and mixed solution is made, as system suitability solution;
The preparation of test solution: it is appropriate to weigh carbetocin, and blank solvent is added to make to dissolve and dilute that test solution is made.
CN201910643080.5A 2019-07-17 2019-07-17 A kind of related substance detecting method of carbetocin bulk pharmaceutical chemicals Pending CN110308222A (en)

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CN111060635A (en) * 2019-11-27 2020-04-24 吉尔生化(上海)有限公司 Analysis and detection method of carbetocin
CN111077243A (en) * 2019-12-16 2020-04-28 成都市海通药业有限公司 Detection method for oxytocin injection
CN113252807A (en) * 2021-04-15 2021-08-13 武汉大安制药有限公司 High performance liquid chromatography separation method for oxytocin raw material medicine related substances

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