CN109521117A - A kind of detection method of the ibuprofen injection in relation to substance - Google Patents
A kind of detection method of the ibuprofen injection in relation to substance Download PDFInfo
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- CN109521117A CN109521117A CN201811494603.6A CN201811494603A CN109521117A CN 109521117 A CN109521117 A CN 109521117A CN 201811494603 A CN201811494603 A CN 201811494603A CN 109521117 A CN109521117 A CN 109521117A
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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
- G01N2030/022—Column chromatography characterised by the kind of separation mechanism
- G01N2030/027—Liquid chromatography
Abstract
A kind of detection method the invention discloses ibuprofen injection in relation to substance, the related substance includes arginine, is detected using high performance liquid chromatography, is carried out qualitatively or quantitatively to related substance, testing conditions include detector: ELSD detector；Chromatographic column: alkyl silane bonded silica gel column or nh 2 column；Mobile phase: including organic phase, water phase, the volume ratio of organic phase and water phase is 50 ~ 70:50 ~ 30, preferably 65:35.Method of the invention can accurately monitor the related substance of arginine, to provide guarantee for the quality of ibuprofen injection and safety.
Description
Technical field
The present invention relates to Drug-related Substances fields, more particularly to a kind of detection side of the ibuprofen injection in relation to substance
Method.
Background technique
Ibuprofen injection is produced by Cumberland Pharmaceuticals company, the U.S., and in June, 2009 is through FDA batches
Quasi- listing, trade name " CALDOLOR " do not enter Chinese market, are mostly inpatient and can not take oral drug therapy
Light, moderate or severe pain crowd and fever crowd.South Korea is in login state at present, and Australia, Canada are in
State before registering.Prescription is made of by patent protection, the injection brufen and arginine, and the two molar ratio is 1:0.92.Its
There are two (1) 4ml:400mg (2) 8ml:800mg for listing specification.Usage and dosage is intravenous drip in its specification.Dosage
It must not exceed 3200mg/ days.Intravenous drip prodrug must dilute.Final concentration is diluted to no more than 4mg/ml.1, ease pain: every 6
Hour intravenous drip dosage is 400mg to 800mg, and the time of instiling must not be lower than 30 minutes.2, antipyretic: every 4-6 hours instillation
After 400mg or 4 hour instillation 100-200mg, if it is necessary, row vein instillation 400mg again, the time of instiling must not be lower than 30 points
Clock.It is domestic temporarily to be listed without ibuprofen injection, there are 30 or more pharmacy corporations to be declared.According to " drug registration Management Office
Method ", this product category chemicals classification 6.
1.1 brufen physicochemical properties, brufen chemical name 2- (4- isobutyl phenenyl) propionic acid, molecular formula C13H18O2,
Molecular weight 206.28.Chemical structural formula: brufen is crystalline white powder, is soluble in ethyl alcohol, acetone, chloroform or second
Ether is practically insoluble in water, readily soluble in sodium hydroxide solution or sodium bicarbonate solution；Fusing point is 74.5-77.5 DEG C.
1.2 mechanism of action and pharmacokinetics, brufen are non-steroidal anti-inflammatory drugs, and substantially mechanism of action may be inhibition epoxidase
Biosynthesis, and epoxidase is the key enzyme of internal synthesis of prostaglandins.It is same that non-steroidal anti-inflammatory drugs reduces prostaglandin synthesis
When reduce the generation of cell factor complicated in inflammatory reaction, this is also antipyretic basis.Brufen can make the patient body that has a fever
Temperature drop does not make significant difference to normal person's body temperature to normal.In animal and adult, the plasma half-life of brufen all compared with
It is short, conjugation product is formed after oxidative metabolism in vivo and is mainly drained through urine.All metabolites found in human body exist
Toxicity research was all carried out in zoopery and there is pharmacological activity.
1.3 in the big perceived social support in the world seven (U.S., Britain, Japan etc.), and NSAIDs is comparatively fast developed, from 1998 to
2008 annual sales amounts rise 116.8 hundred million dollars by 3,800,000,000 dollars, increase by 208%.China produces non-since the forties in last century
Steroidal anti-inflammatory medicine, entire industry have developed more mature.China is Fia, second-biggest-in-the-world NSAIDs production, outlet
State.In terms of hospital administration, non-steroidal anti-inflammatory drugs has become one of maximum kind of amplification.- 2010 years 2005, non-steroidal was anti-
Good growth is presented in the charges for drug cumulative year after year of national 22 city emphasis hospital markets in scorching medicine.It sells within 2010
4.90 hundred million yuan of volume, the first half of the year in 2011 is i.e. to 3.9 hundred million yuan.In entire sample hospital non-steroidal drug medication, brufen
Charges for drug is in the 5th, about 34,340,000 yuan within 2010.Main dosage form is oral and topical administration both at home and abroad.In brufen water
Solubility very little, therefore, certain dosage forms of brufen, especially injection are difficult to develop.But the advantages of injection, absorbs fast, work
With rapid, it be that other dosage forms are irreplaceable, be especially injected intravenously, medical fluid can be directly entered blood circulation, be more suitable for rescue danger
Heavy patient, and without gastrointestinal tract, it is not influenced by digestive system and food.Therefore injection is made in brufen, liver head is avoided to cross effect
It answers, and accelerates the speed of action of brufen.If after listing, it is contemplated that will increase city of the brufen in nonsteroidal analgesic-antipyretic
Market share.
Starting material, intermediate, condensate, the side reaction product mainly brought into process of production in relation to substance, with
And catabolite in storage etc..Related substance research is one of critical project, content in drug quality research
Not only reflect the direct indicator of drug purity, but also there are important security implications, the related substance of injection is even more pharmaceutical research
The most important thing, the present invention has studied a kind of related substance detecting method of ibuprofen injection, ensured ibuprofen injection
High quality and high safety performance.
Summary of the invention
Present invention solves the technical problem that being detection method of the existing ibuprofen injection in relation to substance, when related substance
It when including arginine, is found during application, arginic related substance in ibuprofen injection cannot be detected, but through grinding
Studying carefully in discovery ibuprofen injection arginic has important influence in relation to quality and security performance of the substance to injection.
Specifically, providing a kind of detection method of the ibuprofen injection in relation to substance, carried out using high performance liquid chromatography
Detection, carries out related substance qualitative or quantitative, and testing conditions include,
Detector: ELSD detector；
Chromatographic column: alkyl silane bonded silica gel column or nh 2 column；
Mobile phase: including organic phase, water phase, the volume ratio of organic phase and water phase is 50~70:50~30, preferably 65:
35。
Qualitative detection in the present invention can be used conventional method progress, such as reference substance selected to carry out pair by external standard method
It should analyze, or after separating each ingredient by HPLC, carry out qualitative analysis by general survey means, such as mass spectrum, thin
Layer, ultraviolet etc..
Quantitative detection in the present invention can be used the conventional methods such as external standard method, area normalization method and carry out content calculating.
In quantitative analysis, if being calculated using external standard method using conventional means production standard curve；But fixed
Property analysis when, then without making standard curve, can be determined by retention time.
In one particular embodiment of the present invention, the chromatographic column is nh 2 column.
In one embodiment, the organic phase be selected from methanol or/and acetonitrile, in a specific embodiment of the present invention for
Acetonitrile.
In one embodiment, the water phase is the aqueous solution of potassium-containing hydrogen salt, in a specific embodiment of the present invention
It is ammonium hydrogen carbonate for bicarbonate described in acetonitrile.
In one embodiment, the water phase is 1~10mmol/L bicarbonate aqueous solution, in specific reality of the invention
Applying water phase in example is 5mmol/L ammonium bicarbonate aqueous solution.
In a specific embodiment of the present invention, the chromatographic column is Kromasil 100-5-NH2.
In the present invention, the liquid chromatographic detection condition further include it is below 1.~it is 5. one or more in v:
1. chromatographic column specification: 3.0~4.6mm × 50~300mm, 5 μm, preferably 4.6mm × 250mm, 5 μm；
2. drift tube temperature: 100~115 DEG C, preferably 110 DEG C；
3. carrier gas flux (air): 1.0~3.0L/min, preferably 2.0L/min；
4. sample volume: 10~100 μ l, preferably 50 μ l.
5. mode: shunting.
The carrier gas includes air.
It is in one embodiment, described that detection method includes the following steps:
(1) test solution, reference substance solution are prepared；
(2) respectively by test solution, reference substance solution sample detection.
The test solution is ibuprofen injection to be detected.
The preparation of test solution, reference substance solution, unlimited sequence.
In one embodiment, described to prepare test solution or/and solvent that reference substance solution uses is acetonitrile water
Solution, volume fraction are 50~70%, in a specific embodiment of the present invention acetonitrile solution, volume fraction 65%.
In the present invention, the related substance includes arginic related substance in ibuprofen injection.
Further, the related substance is selected from the mixture of one or both of citrulling, ornithine.
Use method in the prior art that test solution concentration can not be detected for ornithine in 0.15wt%.In order to mention
The detection sensitivity of high ornithine, therefore test solution concentration is improved, and increase sample volume, but because the low wave of wavelength selection
Section, baseline fluctuation significantly increase, and seriously affect the accuracy of experimental result, so that can not normally detect, are examined afterwards using evaporative light
It is low that survey device solves the problems, such as that ornithine responds, and mobile phase is changed to volatile salt.The beneficial effects of the present invention are: using
The related substance of method detection ibuprofen injection of the invention, the related substance of arginine especially in injection detect sensitive
Degree is high, and chromatography peak symmetry is good, and theoretical cam curve is high, can accurately monitor the related substance of arginine, to inject for brufen
The quality of liquid and safety provide guarantee.
Detailed description of the invention
A kind of detection method embodiment 1 blank solution chromatogram of the ibuprofen injection in relation to substance of Fig. 1 present invention；
A kind of detection method embodiment 1 system suitability solution chromatography of the ibuprofen injection in relation to substance of Fig. 2 present invention
Figure；
A kind of detection method embodiment 1 reference substance solution chromatogram of the ibuprofen injection in relation to substance of Fig. 3 present invention；
A kind of detection method embodiment 2 mixed solution chromatogram of the ibuprofen injection in relation to substance of Fig. 4 present invention；
A kind of detection method embodiment 3 mixed solution chromatogram of the ibuprofen injection in relation to substance of Fig. 5 present invention.
Specific embodiment
Embodiment 1
Inspection method: tetra- general rules 0512 of ChP2015, high effective liquid chromatography for measuring.
Instrument: Agilent 1260 matches ELSD detector
Chromatographic column: 100-5-NH2,4.6mm × 250mm, 5 μm of Kromasil or equivalent chromatographic column；
Mobile phase: acetonitrile -5mmol/L ammonium bicarbonate soln=65:35；
Sample volume: 50 μ l；Column temperature: 30 DEG C；Drift tube temperature: 110 DEG C；Carrier gas flux (air): 2.0L/min；
Mode: it shunts.
Diluent (blank solution): 65% acetonitrile solution.
Citrulling reference substance stock solution (0.2mg/ml): it is appropriate that precision weighs citrulling reference substance, uses second again with water dissolution
Nitrile quantitatively dilutes the solution that 0.2mg/ml is made, shake up to get.
Ornithine reference substance stock solution (0.2mg/ml): it is appropriate that precision weighs ornithine reference substance, uses second again with water dissolution
Nitrile quantitatively dilutes the solution that 0.2mg/ml is made, shake up to get.
Citrulling and ornithine reference substance solution: accurate measurement citrulling and ornithine reference substance stock solution are each suitable respectively
Amount, sets in same measuring bottle, solution of every 1ml containing about citrulling and each 0.03mg of ornithine is made with blank solution dilution, as
Reference substance solution.
System suitability solution: precision measures ibuprofen injection 2.0ml and sets in 10ml volumetric flask, then accurate measurement melon ammonia
Acid, each 1.5ml of ornithine reference substance stock solution set in same measuring bottle, be diluted to scale with 65% acetonitrile solution, shake up to get.
Test solution (20mg/ml): precision measures ibuprofen injection 2.0ml and sets in 10ml volumetric flask, with 65% second
Nitrile solution is quantitatively diluted to scale, shake up to get.
Measurement: precision measures each 50 μ l of blank solution, system suitability solution and injects liquid chromatograph, records chromatogram.
Blank solution should not interfere the detection of each known impurities, in system suitability solution citrulling and ornithine with front and back chromatographic peak
Separating degree should meet the requirements.Accurate again to measure reference substance solution and each 50 μ l of test solution, injecting chromatograph records chromatography
Figure.
Criterion: impurity peak area should must not cross the peak area of reference substance solution in test solution.
Embodiment 2
Inspection method: tetra- general rules 0512 of ChP2015, high effective liquid chromatography for measuring.
Instrument: Agilent 1260 matches DAD detector.
Chromatographic column: 100-5-NH2,4.6mm × 250mm, 5 μm of Kromasil or equivalent chromatographic column.
Mobile phase: acetonitrile -5mmol/L ammonium bicarbonate soln=60:40.
Sample volume: 20 μ l；Column temperature: 30 DEG C；Wavelength: 205nm；Flow velocity: 1.3m/min.
Diluent (blank solution): 60% acetonitrile solution.
Citrulling reference substance stock solution (0.6mg/ml): it is appropriate that precision weighs citrulling reference substance, simultaneously with diluent dissolution
The solution of 0.6mg/ml is made in quantitative dilution, shake up to get.
Ornithine reference substance stock solution (1mg/ml): it is appropriate that precision weighs ornithine reference substance, is dissolved and is determined with diluent
The solution of 1mg/ml is made in amount dilution, shake up to get.
Mixed solution: precision weighs arginine about 10mg and sets 5ml measuring bottle, then accurate measurement citrulling reference substance stock solution
1ml is set in same measuring bottle, is quantitatively diluted and is made containing arginine about 2mg/ml with ornithine reference substance stock solution, citrulling is about
The solution of 0.05mg/ml and ornithine about 1mg/ml, as mixed solution.
Measurement: precision measures each 20 μ l of blank solution, impurity stock solution, mixed solution and injects liquid chromatograph, records color
Spectrogram.Blank solution should not interfere the detection of each known impurities, citrulling and ornithine and front and back chromatographic peak in mixed solution
Separating degree should meet the requirements.
As a result: under this condition, by positioning solution (mixed solution) it is found that good separation can be reached between each peak, but
Being is that baseline fluctuation is larger, influences defects inspecting.
Embodiment 3
Inspection method: tetra- general rules 0512 of ChP2015, high effective liquid chromatography for measuring.
Instrument: Agilent 1260 matches DAD detector.
Chromatographic column: 100-5-NH2,4.6mm × 250mm, 5 μm of Kromasil or equivalent chromatographic column.
Mobile phase: acetonitrile -30mmol/L potassium dihydrogen phosphate (pH5.4)=60:40.
Sample volume: 20 μ l；Column temperature: 30 DEG C；Wavelength: 205nm；Flow velocity: 1.3m/min.
Diluent (blank solution): 60% acetonitrile solution.Citrulling reference substance stock solution (0.6mg/ml): precision weighs melon
Propylhomoserin reference substance is appropriate, is dissolved with diluent and quantifies dilution the solution of 0.6mg/ml is made, shake up to get.
Ornithine reference substance stock solution (1mg/ml): it is appropriate that precision weighs ornithine reference substance, is dissolved and is determined with diluent
The solution of 1mg/ml is made in amount dilution, shake up to get.
Mixed solution: precision weighs arginine about 88mg and sets 20ml measuring bottle, then accurate measurement citrulling and ornithine respectively
Reference substance stock solution is each appropriate, sets in same measuring bottle, every 1ml about arginine about 5mg is made with dilution dilution agent, containing citrulling and
The solution of each about 0.008mg of ornithine, as mixed solution.
Test solution (2mg/ml): precision measures ibuprofen injection 1.0ml and sets in 50ml volumetric flask, with 60% acetonitrile
Solution is quantitatively diluted to scale, shake up to get.
Measurement: precision measures each 20 μ l of blank solution, impurity stock solution, mixed solution and injects liquid chromatograph, records color
Spectrogram.Blank solution should not interfere the detection of each known impurities, citrulling and ornithine and front and back chromatographic peak in mixed solution
Separating degree should meet the requirements.Accurate again to measure each 20 μ l of test solution, injecting chromatograph records chromatogram.As a result: at this
Under part, by the chromatogram of positioning solution (mixed solution) it is found that good separation can be reached between each peak, but mixed solution map
In, ornithine is because responding lower non-appearance.
The above description is only an embodiment of the present invention, is not intended to limit the scope of the invention, all to utilize this hair
Equivalent structure or equivalent flow shift made by bright description is applied directly or indirectly in other relevant technology necks
Domain is included within the scope of the present invention.
Claims (10)
1. a kind of detection method of ibuprofen injection in relation to substance, which is characterized in that examined using high performance liquid chromatography
It surveys, related substance is carried out qualitative or quantitative, testing conditions include,
Detector: ELSD detector；
Chromatographic column: alkyl silane bonded silica gel column or nh 2 column；
Mobile phase: including organic phase, water phase, the volume ratio of organic phase and water phase is 50 ~ 70:50 ~ 30, preferably 65:35.
2. detection method of a kind of ibuprofen injection in relation to substance according to claim 1, which is characterized in that the color
Spectrum column is nh 2 column.
3. detection method of a kind of ibuprofen injection in relation to substance according to claim 1, which is characterized in that described to have
Machine is mutually selected from methanol or/and acetonitrile, preferably acetonitrile.
4. detection method of a kind of ibuprofen injection in relation to substance according to claim 1, which is characterized in that the water
It is mutually the aqueous solution of potassium-containing hydrogen salt, the bicarbonate is preferably ammonium hydrogen carbonate.
5. detection method of a kind of ibuprofen injection in relation to substance according to claim 1 or 4, which is characterized in that institute
Stating water phase is 1 ~ 10mmol/L bicarbonate aqueous solution, preferably 5mmol/L ammonium bicarbonate aqueous solution.
6. detection method of a kind of ibuprofen injection in relation to substance according to claim 1, which is characterized in that the color
Spectrum column is Kromasil 100-5-NH2.
7. detection method of a kind of ibuprofen injection in relation to substance according to claim 1, which is characterized in that the liquid
Phase chromatographic test strip part further include it is below 1. ~ 4. in it is one or more:
1. chromatographic column specification: 3.0 ~ 4.6mm × 50 ~ 300mm, 5 μm, preferably 4.6mm × 250mm, 5 μm；
2. drift tube temperature: 100 ~ 115 DEG C, preferably 110 DEG C；
3. carrier gas flux: 1.0 ~ 3.0 L/min, preferably 2.0L/min；
4. sample volume: 10 ~ 100 μ l, preferably 50 μ l.
8. detection method of a kind of ibuprofen injection in relation to substance according to claim 1, which is characterized in that the inspection
Survey method the following steps are included:
(1) test solution, reference substance solution are prepared；
(2) respectively by test solution, reference substance solution sample detection.
9. detection method of a kind of ibuprofen injection in relation to substance according to claim 1, which is characterized in that described to have
Closing substance includes arginic related substance.
10. detection method of a kind of ibuprofen injection in relation to substance according to claim 9, which is characterized in that described
Arginic related substance is selected from the mixture of one or both of citrulling, ornithine.
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| CN112526013A (en) * | 2020-11-20 | 2021-03-19 | 人福普克药业（武汉）有限公司 | Method for detecting concentration of related substances in ibuprofen medicament based on ultra-high liquid chromatography |
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| CN112526013A (en) * | 2020-11-20 | 2021-03-19 | 人福普克药业（武汉）有限公司 | Method for detecting concentration of related substances in ibuprofen medicament based on ultra-high liquid chromatography |
| CN112526013B (en) * | 2020-11-20 | 2022-09-06 | 人福普克药业（武汉）有限公司 | Method for detecting concentration of related substances in ibuprofen medicament by using ultra-high liquid chromatography |
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