CN110133134A - A kind of analysis method measuring Quetiapine fumarate sustained-release tablets release - Google Patents
A kind of analysis method measuring Quetiapine fumarate sustained-release tablets release Download PDFInfo
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- CN110133134A CN110133134A CN201910414624.0A CN201910414624A CN110133134A CN 110133134 A CN110133134 A CN 110133134A CN 201910414624 A CN201910414624 A CN 201910414624A CN 110133134 A CN110133134 A CN 110133134A
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- quetiapine fumarate
- sodium sulfate
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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
- G01N2030/022—Column chromatography characterised by the kind of separation mechanism
- G01N2030/027—Liquid chromatography
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Abstract
The invention discloses a kind of analysis methods for measuring Quetiapine fumarate sustained-release tablets release, about measurement Quetiapine fumarate sustained-release tablets release, dissolution medium in the release method is made of water, buffer salt and surfactant, using liquid chromatography analysis test sample.The quetiapine fumarate burst size in the release experimentation of Quetiapine fumarate sustained-release tablets can be improved in dissolution medium in the measuring method, establishes suitable chromatographic condition, achievees the purpose that analysis.
Description
Technical field
Present invention relates particularly to a kind of analysis methods, measure the release of Quetiapine fumarate sustained-release tablets.
Background technique
A kind of nerve drug of Quetiapine fumarate sustained-release tablets, can be used for treating feature and the disease of idiopathic parkinsonism
Shape.The chapters and sections of Quetiapine fumarate sustained-release tablets are not included in Chinese Pharmacopoeia temporarily, are delayed in United States Pharmacopeia about quetiapine fumarate
Releasing piece release is after being tested 4 hours using the buffer solution of the pH4.8 of 900ml as dissolution medium, and reconvert is to 1000ml's
In the buffer solution of pH6.6, it is measured using<711>first method basket method of United States Pharmacopeia.Pass through biology to what we developed
The Quetiapine fumarate sustained-release tablets (200mg) of equivalence preliminary experiment are tested according to above-mentioned release method, in the release
Under the conditions of, it is not achieved 80% in the release at 24 hours the last one time points, does not reach the requirement discharged substantially.Fumaric acid
Quetiapine is water-soluble fine substance, and in 6.6 phosphoric acid solution of pH, solubility > 0.77mg/ml meets sink conditions.
Basic release is not reached under this method this is because having the hydroxypropylcellulose of 50% high viscosity specification, meeting in the prescription developed
Swelling causes drug that cannot be released under this condition.Therefore a new dissolution medium is developed, hydroxypropyl containing high viscosity is made
The Quetiapine fumarate sustained-release tablets of cellulose reach release (> 85%) completely in release experimentation has realistic meaning.
Summary of the invention
The purpose of the present invention is to overcome the above shortcomings, provide it is a kind of analysis quickly, strong interference immunity, high sensitivity
Measurement Quetiapine fumarate sustained-release tablets release analysis method.
The purpose of the present invention is achieved through the following technical solutions: a kind of measurement Quetiapine fumarate sustained-release tablets release
Analysis method, comprising the following steps:
A, the preparation of dissolution medium, dissolution medium are the phosphate-buffered salt of the pH6.8 containing 1% lauryl sodium sulfate:
The phosphate-buffered salt of pH6.8: ten sodium dihydrogen phosphate dihydrate and monohydrate potassium are dissolved in the water, and phosphoric acid is added,
It is uniformly mixed, adjusts pH to 6.8 with phosphoric acid or sodium hydroxide, the lauryl sodium sulfate of addition is uniformly mixed；
B, leaching condition:<711>first method of United States Pharmacopeia, basket method, medium volume 500ml, revolving speed: 100rpm, temperature:
37℃±0.5℃；
C, Quetiapine fumarate sustained-release tablets 6 are taken, investment is operated according to methods equipped in each stripping rotor of dissolution medium respectively, respectively
At 1,2,4,6,9,12,16,20 and 24 hour, dissolution sample solution was taken out from each stripping rotor, will dissolve out sample solution
Through the filtering of 0.45mm pin type filter or centrifuging and taking supernatant；
D, using the release of liquid chromatography for measuring Quetiapine fumarate sustained-release tablets:
The preparation of the phosphate buffered saline solution of the pH6.3 of 0.05% lauryl sodium sulfate: diammonium hydrogen phosphate and triethylamine are dissolved in
In the water of 1L, with phosphorus acid for adjusting pH to 6.3, lauryl sodium sulfate is added, is uniformly mixed；
Chromatographic condition are as follows: chromatographic column: octadecylsilane chemically bonded silica is filler, and column length 100mm, internal diameter 4.6mm are filled out
Fill grain diameter 5mm；Column temperature: 50 DEG C；Flow velocity: 1.0 ml/mins；Detection wavelength: UV280nm, sampling volume: 10 μ L, fortune
The row time: 7 minutes.
A further improvement of the present invention is that: in step A, the pH6.8 phosphate-buffered salt containing 1.0% lauryl sodium sulfate
The production method of solution are as follows: the monohydrate potassium of ten sodium dihydrogen phosphate dihydrate of 22g and 1.9g is dissolved in the water of 4L,
The phosphoric acid of 0.5ml is added, is uniformly mixed, adjusts pH to 6.8 with phosphoric acid or sodium hydroxide, the dodecyl sulphate of 40.0g is added
Sodium is uniformly mixed.
A further improvement of the present invention is that: in step D, the pH6.3 phosphate-buffered salt of 0.05% lauryl sodium sulfate is molten
The production method of liquid are as follows: the triethylamine of 3.96g diammonium hydrogen phosphate and 1ml is dissolved in the water of 1L, with phosphorus acid for adjusting pH to 6.3,
The lauryl sodium sulfate of 0.5g is added, is uniformly mixed.
A further improvement of the present invention is that: in step D, the pH6.3 phosphate-buffered salt of 0.05% lauryl sodium sulfate is molten
The ratio of liquid and acetonitrile is 65:35.
Compared with the prior art, the present invention has the following advantages:
The present invention provides a kind of medium that dissolution is made of water, buffer salt and surfactant, and it is fine can to improve highly viscous hydroxypropyl
The case where dimension element swelling causes drug that must not release, and one suitable analysis method of offer ensures chromatographic peak retention time
Stablize, peak shape is good, achievees the purpose that analysis.
Detailed description of the invention:
Fig. 1 is solvent blank solution chromatogram；
Fig. 2 is reference substance chromatogram；
The sample chromatogram figure of Fig. 3 embodiment one；
The sample chromatogram figure of Fig. 4 embodiment two.
Specific embodiment:
It in order to make the object, technical scheme and advantages of the embodiment of the invention clearer, below will be to the skill in the embodiment of the present invention
Art scheme is clearly and completely described, it is clear that and described embodiment is a module embodiments of the invention, rather than all
Embodiment.The elements and features described in one embodiment of the invention can be with one or more other embodiment party
Elements and features shown in formula combine.It should be noted that being omitted for purposes of clarity, in explanation unrelated to the invention
, the expression and description of component known to persons of ordinary skill in the art and processing.Based on the embodiments of the present invention, this field
Those of ordinary skill's every other embodiment obtained under the premise of not making the creative labor, belongs to guarantor of the present invention
The range of shield.
A kind of analysis method measuring Quetiapine fumarate sustained-release tablets release, about measurement Quetiapine fumarate sustained-release tablets
Release.Dissolution medium in the release method is by water, buffer salt and surfactant composition, using liquid chromatography
Analyze test sample.Dissolution medium in the measuring method can improve highly viscous hydroxypropylcellulose swelling, and piece cannot
Disintegration completely, the case where causing drug that must not release completely, the color obtained under the chromatographic condition in the measuring method
Spectral peak retention time is stablized, and peak shape is good, can achieve the purpose of analysis.
Embodiment one
Quetiapine fumarate sustained-release tablets agent (specification: 200mg, lot number: 19RD425001 contains 50% hydroxypropylcellulose K4M) releases
Degree of putting measurement:
(1), instrument and condition:
Digestion instrument: Agilent digestion instrument,<711>first method of United States Pharmacopeia, blue laws；
Dissolution medium: the buffer salt of the pH6.8 containing 1.0% sodium dodecyl sulfate solution；
Medium volume: 500ml；
Revolving speed: 100rpm；
Temperature: 37 °C ± 0.5 °C；
Sampling mode: automatic sampling；
Sample volume: 10ml；
Sample time: 1,2,4,6,9,12,16,20 and 24 hours.
(2), experimental procedure:
Take this product 6, it is weighed and record single slice weight, it puts into each stripping rotor, operates according to methods respectively, respectively 1,2,4,6,9,
12,16,20 and 24 hours, dissolution solution is taken out from each stripping rotor, by dissolution sample solution through 0.45mm pin type filter (factory
Family: An Pu, diameter: 25mm) filtration, discard primary filtrate 3ml.
Inject the blank solution (dissolution medium) of 80 μ l into high performance liquid chromatograph respectively, reference substance solution and each for examination
Product solution, record chromatogram and integral analysis.
Mobile phase are as follows: the dodecyl pH value containing 0.05% is 6.3 sodium sulphate buffer salt solutions (by 3.96g phosphoric acid hydrogen two
The triethylamine of ammonium and 1ml are dissolved in the water of 1L, with phosphorus acid for adjusting pH to 6.3.The lauryl sodium sulfate of 500mg, mixing is added
Uniformly.): acetonitrile=65:35；
Chromatographic condition are as follows: chromatographic column: water generation octadecylsilane chemically bonded silica chromatographic column (Xbridge C18), column length
100mm, internal diameter 4.6mm, filler particles partial size 5mm；Column temperature: 50 DEG C；Flow velocity: 1.0 ml/mins；Detection wavelength:
UV280nm, sampling volume: 10 μ L, runing time: 7 minutes.
Methodological study:
Sample introduction reproducibility: reference substance solution is taken continuously into 6 needles, to calculate the %RSD, % of the peak area of quetiapine fumarate chromatographic peak
RSD is respectively less than 3.0, and the precision of illustration method is good.
Specificity: in reference substance solution, the retention time of quetiapine fumarate is respectively 2.1 minutes, blank solution and sky
White auxiliary material is interference in this retention time.
The rate of recovery: the rate of recovery under three kinds of concentration levels is examined, as a result within the scope of 97.0%-103.0%.
Repeatability: in most latter two sample point, the %RSD of 6 quetiapine fumarate results measured is respectively less than 10.0；?
The last one sample point repeats sampling 6 times, and the %RSD of the measurement result of quetiapine fumarate is respectively less than 2.0；
Stability: reference substance solution and test solution are set to place under experimental bench in two days at room temperature and be stablized.
Measurement result:
1 hour: 20%；2 hours: 29%；4 hours: 43%；6 hours: 53%；9 hours: 64%；
12 hours: 73%；16 hours: 81%；20 hours: 87%；24 hours: 91%.
Embodiment two
Quetiapine fumarate sustained-release tablets agent (specification: 200 mg, lot number: 19RD425002 contains 50% hydroxypropylcellulose K15M)
Drug release determination:
(1), instrument and condition:
Digestion instrument: Agilent digestion instrument,<711>first method of United States Pharmacopeia, blue laws；
Dissolution medium: the buffer salt of the pH6.8 containing 1.0% sodium dodecyl sulfate solution；
Medium volume: 500ml；
Revolving speed: 100rpm；
Temperature: 37 °C ± 0.5 °C；
Sampling mode: automatic sampling；
Sample volume: 10ml；
Sample time: 1,2,4,6,9,12,16,20 and 24 hours.
(2), experimental procedure:
Take this product 6, it is weighed and record single slice weight, it puts into each stripping rotor, operates according to methods respectively, respectively 1,2,4,6,9,
12,16,20 and 24 hours, dissolution solution is taken out from each stripping rotor, by dissolution sample solution through 0.45mm pin type filter (factory
Family: An Pu, diameter: 25mm) filtration, discard primary filtrate 2ml.
Inject the blank solution (dissolution medium) of 10 μ l into high performance liquid chromatograph respectively, reference substance solution and each for examination
Product solution, record chromatogram and integral analysis.
Mobile phase are as follows: the dodecyl pH value containing 0.05% is 6.3 sodium sulphate buffer salt solutions (by 3.96g phosphoric acid hydrogen two
The triethylamine of ammonium and 1ml are dissolved in the water of 1L, with phosphorus acid for adjusting pH to 6.3.The lauryl sodium sulfate of 500mg, mixing is added
Uniformly.): acetonitrile=65:35；
Chromatographic condition are as follows: chromatographic column: water generation octadecylsilane chemically bonded silica chromatographic column (XBridge C18), column length
100mm, internal diameter 4.6mm, filler particles partial size 5mm；Column temperature: 50 DEG C；Flow velocity: 1.0 ml/mins；Detection wavelength:
UV280nm, sampling volume: 10 μ L, runing time: 7 minutes.
System suitability:
Reference substance solution is taken continuously into 6 needles, to calculate the %RSD of the peak area of Quetiapine chromatographic peak, %RSD is respectively less than 3.0, conforms to
It asks；
Measurement result:
1 hour: 21%；2 hours: 30%；4 hours: 43%；6 hours: 54%；9 hours: 66%；
12 hours: 75%；16 hours: 84%；20 hours: 90%；24 hours: 94%.
The present invention measures richness with the phosphate buffered saline containing 1.0% lauryl sodium sulfate is dissolution medium for the first time
The release of horse acid quetiapine sustained release tablet, and use containing 0.05% lauryl sodium sulfate buffer salt and acetonitrile mixture as
Mobile phase achievees the purpose that analysis.
Finally, it should be noted that although the present invention and its advantage have been described in detail above it should be appreciated that not
Can be carried out in the case where beyond the spirit and scope of the present invention being defined by the claims appended hereto various changes, substitution and
Transformation.Moreover, the scope of the present invention is not limited only to the specific reality of process, equipment described in specification, means, method and steps
Apply example.One of ordinary skilled in the art holds from the disclosure it will be readily understood that can be used according to the present invention
The row function essentially identical to corresponding embodiment described herein obtains the result essentially identical with it, existing and future
Process, equipment, means, method or step to be developed.Therefore, the attached claims are intended to wrap in the range of them
Include such process, equipment, means, method or step.
Claims (4)
1. a kind of analysis method for measuring Quetiapine fumarate sustained-release tablets release, it is characterised in that: the following steps are included:
A, the preparation of dissolution medium, dissolution medium are the phosphate-buffered salt of the pH6.8 containing 1% lauryl sodium sulfate:
The phosphate-buffered salt of pH6.8: ten sodium dihydrogen phosphate dihydrate and monohydrate potassium are dissolved in the water, and phosphoric acid is added,
It is uniformly mixed, adjusts pH to 6.8 with phosphoric acid or sodium hydroxide, the lauryl sodium sulfate of addition is uniformly mixed；
B, leaching condition:<711>first method of United States Pharmacopeia, basket method, medium volume 500ml, revolving speed: 100rpm, temperature:
37℃±0.5℃；
C, Quetiapine fumarate sustained-release tablets 6 are taken, investment is operated according to methods equipped in each stripping rotor of dissolution medium respectively, respectively
At 1,2,4,6,9,12,16,20 and 24 hour, dissolution sample solution was taken out from each stripping rotor, will dissolve out sample solution
Through the filtering of 0.45mm pin type filter or centrifuging and taking supernatant；
D, using the release of liquid chromatography for measuring Quetiapine fumarate sustained-release tablets:
The preparation of the phosphate buffered saline solution of the pH6.3 of 0.05% lauryl sodium sulfate: diammonium hydrogen phosphate and triethylamine are dissolved in
In the water of 1L, with phosphorus acid for adjusting pH to 6.3, lauryl sodium sulfate is added, is uniformly mixed；
Chromatographic condition are as follows: chromatographic column: octadecylsilane chemically bonded silica is filler, and column length 100mm, internal diameter 4.6mm are filled out
Fill grain diameter 5mm；Column temperature: 50 DEG C；Flow velocity: 1.0 ml/mins；Detection wavelength: UV280nm, sampling volume: 10 μ L, fortune
The row time: 7 minutes.
2. a kind of analysis method for measuring Quetiapine fumarate sustained-release tablets release according to claim 1, it is characterised in that:
In step A, the production method of the pH6.8 phosphate buffered saline solution containing 1.0% lauryl sodium sulfate are as follows: by 12 hydrations of 22g
The monohydrate potassium of sodium dihydrogen phosphate and 1.9g are dissolved in the water of 4L, and the phosphoric acid of 0.5ml is added, and are uniformly mixed, are used phosphoric acid
Or sodium hydroxide adjusts pH to 6.8；The lauryl sodium sulfate of 40.0g is added, is uniformly mixed.
3. a kind of analysis method for measuring Quetiapine fumarate sustained-release tablets release according to claim 1, it is characterised in that:
In step D, the production method of the pH6.3 phosphate buffered saline solution of 0.05% lauryl sodium sulfate are as follows: by 3.96g phosphoric acid hydrogen two
The triethylamine of ammonium and 1ml are dissolved in the water of 1L, with phosphorus acid for adjusting pH to 6.3, the lauryl sodium sulfate of 0.5g are added, mixing is equal
It is even.
4. a kind of analysis method for measuring Quetiapine fumarate sustained-release tablets release according to claim 1, it is characterised in that:
In step D, the pH6.3 phosphate buffered saline solution of 0.05% lauryl sodium sulfate and the ratio of acetonitrile are 65:35.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110967433A (en) * | 2019-12-28 | 2020-04-07 | 湖南九典制药股份有限公司 | Method for measuring dissolution rate of potassium sodium hydrogen citrate |
| CN112834679A (en) * | 2020-12-31 | 2021-05-25 | 苏州海科医药技术有限公司 | Analysis method for clinically researching concentration of quetiapine in plasma sample |
| CN114137130A (en) * | 2021-12-21 | 2022-03-04 | 南通联亚药业有限公司 | Method for detecting release degree of pramipexole dihydrochloride sustained-release tablets |
| CN114814045A (en) * | 2022-06-27 | 2022-07-29 | 湖南慧泽生物医药科技有限公司 | Method for determining in-vitro release degree of quetiapine fumarate sustained release tablets |
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| CN103076410A (en) * | 2013-01-06 | 2013-05-01 | 江苏长泰药业有限公司 | Dissolution rate detection method for simvastatin |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110967433A (en) * | 2019-12-28 | 2020-04-07 | 湖南九典制药股份有限公司 | Method for measuring dissolution rate of potassium sodium hydrogen citrate |
| CN112834679A (en) * | 2020-12-31 | 2021-05-25 | 苏州海科医药技术有限公司 | Analysis method for clinically researching concentration of quetiapine in plasma sample |
| CN114137130A (en) * | 2021-12-21 | 2022-03-04 | 南通联亚药业有限公司 | Method for detecting release degree of pramipexole dihydrochloride sustained-release tablets |
| CN114814045A (en) * | 2022-06-27 | 2022-07-29 | 湖南慧泽生物医药科技有限公司 | Method for determining in-vitro release degree of quetiapine fumarate sustained release tablets |
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