CN107782812A - The method for detecting docusa soft capsule cleaning residual quantity - Google Patents
The method for detecting docusa soft capsule cleaning residual quantity Download PDFInfo
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- CN107782812A CN107782812A CN201610747648.4A CN201610747648A CN107782812A CN 107782812 A CN107782812 A CN 107782812A CN 201610747648 A CN201610747648 A CN 201610747648A CN 107782812 A CN107782812 A CN 107782812A
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Abstract
The invention discloses a kind of method for detecting docusa soft capsule cleaning residual quantity, this method includes：Docusa to be measured is detected by HPLC methods, wherein, the condition of the HPLC methods is：HPLC chromatogram post：C18, 5 microns, 4.6 × 150 millimeters or equivalent post；Mobile phase：The mixed solution of the mol/L tetrabutyl ammonium hydrogen phosphate aqueous solution of 34 parts by volume 0.01 and 66 parts by volume of acetonitrile；Flow velocity：1.5 ml/min；Sample size：100 microlitres；Column temperature：30 degrees Celsius；Detection wavelength：214 nanometers.Thus, this method is used to clean residual quantity with Accurate Determining docusa soft capsule.
Description
Technical field
The present invention relates to pharmaceutical technology field, and specifically, present aspect is related to a kind of detection docusa soft capsule cleaning
The method of residual quantity.
Background technology
Docusa soft capsule is a kind of surfactant, and water and lipoid material can be made to immerse excrement after oral in the intestine
Just, its softening is promoted.In the production process of docusa soft capsule, docusa active pharmaceutical ingredient can remain in process units
On, and docusa is insoluble in water and common organic solvents, is typically dissolved in corn oil, and ultraviolet response is weaker, remains limit
It is low, it is difficult to Accurate Determining.
Thus, the method for detection docusa soft capsule cleaning residual quantity still needs further to be studied.
The content of the invention
It is contemplated that at least solves one of technical problem in correlation technique to a certain extent.Therefore, the present invention
One purpose is to propose a kind of method for detecting docusa soft capsule cleaning residual quantity.
In one aspect of the invention, the present invention proposes a kind of side for detecting docusa soft capsule cleaning residual quantity
Method.According to an embodiment of the invention, this method includes：Docusa to be measured is detected by HPLC methods, the HPLC methods
Condition be：HPLC chromatogram post：C18, 5 microns, 4.6 × 150 millimeters or equivalent post；Mobile phase：The mol/L of 34 parts by volume 0.01
The mixed solution of the tetrabutyl ammonium hydrogen phosphate aqueous solution and 66 parts by volume of acetonitrile；Flow velocity：1.5 ml/min；Sample size：100 is micro-
Rise；Column temperature：30 degrees Celsius；Detection wavelength：214 nanometers.Thus, use this method clear with Accurate Determining docusa soft capsule
Clean residual quantity.
In addition, the method for detection docusa soft capsule cleaning residual quantity according to the above embodiment of the present invention can also have
There is technical characteristic additional as follows：
In some embodiments of the invention, the docusa to be measured for production docusa soft capsule during remain
Docusa active pharmaceutical ingredient in process units.
In some embodiments of the invention, the docusa to be measured on every 25 square centimeters of plates is determined based on following formula
Amount：
Wherein, AsplRepresent the peak area of docusa sample to be measured in HPLC methods detection collection of illustrative plates；AstdRepresent the inspection of HPLC methods
The peak area of docusa reference substance in mapping spectrum；Std wt represent the sample weighting amount of docusa reference substance, and unit is milligram；P
The purity of docusa in docusa reference substance is represented, unit is milligram/milligram；RF represents the average recovery of docusa
Rate.Thus, it is possible to significantly improve the degree of accuracy for measuring docusa soft capsule cleaning residual quantity.
The additional aspect and advantage of the present invention will be set forth in part in the description, and will partly become from the following description
Obtain substantially, or recognized by the practice of the present invention.
Brief description of the drawings
The above-mentioned and/or additional aspect and advantage of the present invention will become in the description from combination accompanying drawings below to embodiment
Substantially and it is readily appreciated that, wherein：
Fig. 1 is the HPLC spectrograms of diluent 50v% acetonitrile solutions according to an embodiment of the invention；
Fig. 2 is the HPLC spectrograms of cleaning agent standard liquid according to an embodiment of the invention；
Fig. 3 is the HPLC spectrograms of blank cotton swab extraction solution according to an embodiment of the invention；
Fig. 4 is the HPLC spectrograms of docusa reference substance according to an embodiment of the invention；
Fig. 5 is the HPLC spectrograms of docusa sample to be measured according to an embodiment of the invention；
Fig. 6 is docusa canonical plotting according to an embodiment of the invention.
Embodiment
Embodiments of the invention are described below in detail.The embodiments described below is exemplary, is only used for explaining this hair
It is bright, and be not considered as limiting the invention.Unreceipted particular technique or condition in embodiment, according to text in the art
Offer described technology or condition or carried out according to product description.Agents useful for same or the unreceipted production firm person of instrument,
For the conventional products of acquisition purchased in market can be passed through.
In one aspect of the invention, the present invention proposes a kind of side for detecting docusa soft capsule cleaning residual quantity
Method.The method for cleaning residual quantity to detection docusa soft capsule according to embodiments of the present invention below is described in detail.Root
According to embodiments of the invention, this method includes：
Step (1)：Prepare reference substance stock solution
In this step, docusa reference substance stock solution is prepared.Specifically, prepare 2 parts according to the following steps are parallel
Reference substance stock solution, (a), which is weighed, have been determined the docusa reference substance of moisture and has been placed in 100mL volumetric flasks, and (b) is added
Appropriate acetonitrile solution shaking makes its dissolving, and (c) is settled to 100mL using acetonitrile solution.
According to one embodiment of present invention, weigh the weight of the docusa reference substance for having determined moisture not by
Especially limitation, those skilled in the art can be selected according to being actually needed, and one according to an embodiment of the invention specific
Embodiment, the weight for weighing the docusa reference substance for having determined moisture can be 50mg, thus, it is possible to after significantly improving
The degree of accuracy of docusa soft capsule cleaning residual quantity is measured in continuous detecting step.
According to still a further embodiment, the concentration of acetonitrile solution is not particularly restricted, people in the art
Member can be selected according to being actually needed, a specific embodiment according to an embodiment of the invention, acetonitrile solution it is dense
Degree can be 50v%, and docusa soft capsule cleaning residual quantity is measured in following detection step thus, it is possible to further improve
The degree of accuracy.
Step (2)：Prepare reference substance solution
In this step, it is diluted preparation reference substance solution by measuring reference substance stock solution.Specifically, (d) is measured
Reference substance stock solution is taken to be placed in 50mL volumetric flasks, (e) adds acetonitrile solution and be settled to 50mL, and shaking makes its mixing.
According to one embodiment of present invention, the volume for measuring reference substance stock solution is not particularly restricted, this area
Technical staff can be selected according to being actually needed, and a specific embodiment according to an embodiment of the invention, measure control
The volume of product stock solution can be 5mL, and inventor is by testing it was unexpectedly observed that measuring the reference substance stock solution of the volume
The degree of accuracy that docusa soft capsule cleaning residual quantity is measured in following detection step can further be improved.
According to still a further embodiment, the concentration of acetonitrile solution is not particularly restricted, people in the art
Member can be selected according to being actually needed, a specific embodiment according to an embodiment of the invention, acetonitrile solution it is dense
Degree can be 50v%, and docusa soft capsule cleaning residual quantity is measured in following detection step thus, it is possible to further improve
The degree of accuracy.
Step (3)：Prepare specificity solution
In this step, blank cotton swab extraction solution is prepared first, specifically, blank cotton swab is put into vial,
Diluent 50v% acetonitrile solutions are added, vial is sealed and carries out ultrasound successively, vortex processing, to obtain blank
Cotton swab extracts solution.In addition, inventor has prepared the cleaning agent CIP-100 solution that concentration is 50 μ g/mL, as cleaning agent standard
Solution.
According to one embodiment of present invention, the volume for adding diluent 50v% acetonitrile solutions is not particularly restricted,
Those skilled in the art can be selected according to the actual requirements, according to the specific embodiment of the present invention, add diluent
The volume of 50v% acetonitrile solutions can be 4.0mL, and docusa is measured in following detection step thus, it is possible to significantly improve
Soft capsule cleans the degree of accuracy of residual quantity.
According to still a further embodiment, ultrasound, the condition for the processing that is vortexed are not particularly restricted, art technology
Personnel can be selected according to the actual requirements, and according to the specific embodiment of the present invention, ultrasound, the condition for the processing that is vortexed can
Think ultrasonic 5min, vortex 1min, the cleaning of docusa soft capsule is measured in following detection step thus, it is possible to further improve
The degree of accuracy of residual quantity.
Step (4)：Wipe docusa process units
In this step, by using cotton swab docusa process units, to obtain docusa sample to be measured
Solution.Specifically, selecting multiple sample points in docusa process units, the area of each sample point is 25 square centimeters,
Wherein each sample point, which matches somebody with somebody a vial and posts respective labels respectively, to be distinguish between, and blank cotton swab is put into vial
And diluent 50v% acetonitrile solutions are added, with blank cotton swab in each sample point by from left to right or from top to bottom direction wipes,
Wipe and cotton swab has been put into corresponding vial, vial is sealed and carries out ultrasound successively, vortex processing, so as to
To docusa sample solution to be measured.
According to one embodiment of present invention, the volume for adding diluent 50v% acetonitrile solutions is not particularly restricted,
Those skilled in the art can be selected according to the actual requirements, according to the specific embodiment of the present invention, add diluent
The volume of 50v% acetonitrile solutions can be 4.0mL, and docusa is measured in following detection step thus, it is possible to significantly improve
Soft capsule cleans the degree of accuracy of residual quantity.
According to still a further embodiment, ultrasound, the condition for the processing that is vortexed are not particularly restricted, art technology
Personnel can be selected according to the actual requirements, and according to the specific embodiment of the present invention, ultrasound, the condition for the processing that is vortexed can
Think ultrasonic 5min, vortex 1min, the cleaning of docusa soft capsule is measured in following detection step thus, it is possible to further improve
The degree of accuracy of residual quantity.
Step (5)：Gather docusa characteristic peak
In this step, the characteristic peak of docusa reference substance and docusa sample to be measured is gathered by HPLC methods.Tool
Body, the HPLC methods condition includes：HPLC chromatogram post：C18, 5 microns, 4.6 × 150 millimeters or equivalent post；Mobile phase：34 bodies
The mixed solution of the product mol/L tetrabutyl ammonium hydrogen phosphate aqueous solution of part 0.01 and 66 parts by volume of acetonitrile；Flow velocity：1.5 ml/min
Clock；Sample size：100 microlitres；Column temperature：30 degrees Celsius；Detection wavelength：214 nanometers.Thus, use this method can be with Accurate Determining
Docusa soft capsule cleans residual quantity.
Inventor by experiment it was unexpectedly observed that the chromatographic condition in detecting step can significantly affect detection obtain it is more
The accuracy of storehouse ester calcium soft capsule cleaning residual quantity.In view of this, inventor therefrom determines above-mentioned chromatogram by many experiments
Condition, thus, it is possible to significantly improve the degree of accuracy of docusa soft capsule cleaning residual quantity.
Step (6)：Determine that docusa soft capsule cleans residual quantity
In this step, the amount of the docusa to be measured on every 25 square centimeters of plates is determined based on following formula：
Wherein, AsplRepresent the peak area of docusa sample to be measured in HPLC methods detection collection of illustrative plates；AstdRepresent the inspection of HPLC methods
The peak area of docusa reference substance in mapping spectrum；Std wd represent the sample weighting amount of docusa reference substance, and unit is milligram；P
The purity of docusa in docusa reference substance is represented, unit is milligram/milligram；RF represents the average recovery of docusa
Rate.Thus, it is possible to significantly improve the degree of accuracy for measuring docusa soft capsule cleaning residual quantity.
Below with reference to specific embodiment, present invention is described, it is necessary to which explanation, these embodiments are only to describe
Property, without limiting the invention in any way.
Conventional method
Unless stated otherwise, HPLC detections are carried out using following method in embodiment below：
HPLC method conditions include：HPLC chromatogram post：C18, 5 microns, 4.6 × 150 millimeters or equivalent post；Mobile phase：34 volumes
The mixed solution of the 0.01 mol/L tetrabutyl ammonium hydrogen phosphate aqueous solution of part and 66 parts by volume of acetonitrile；Flow velocity：1.5 ml/min；
Sample size：100 microlitres；Column temperature：30 degrees Celsius；Detection wavelength：214 nanometers.The retention time of docusa is 4.7min.
Embodiment 1
In the present embodiment, inventor has measured diluent 50v% acetonitrile solutions according to the description of conventional method
HPLC spectrograms, with reference to figure 1, going out for diluent is noiseless between peak position and docusa characteristic peak positions.
Embodiment 2
In the present embodiment, inventor has measured cleaning agent standard liquid according to the description of conventional method, with reference to figure 2, clearly
Going out for lotion standard liquid is noiseless between peak position and docusa characteristic peak positions.
Embodiment 3
In the present embodiment, blank cotton swab is put into vial by inventor, adds 4.0mL diluent 50v% second
The nitrile aqueous solution, by vial sealing and ultrasound 5 minutes, be vortexed 1 minute, so as to obtain blank cotton swab extraction solution, then press
Description according to conventional method measures the HPLC spectrograms of blank cotton swab extraction solution, and with reference to figure 3, blank cotton swab extracts the appearance of solution
It is noiseless between position and docusa characteristic peak positions.
Embodiment 4
In the present embodiment, inventor is prepared for docusa reference substance stock solution and docusa reference substance solution,
And the HPLC spectrograms of docusa reference substance solution are measured according to the description of conventional method.Specifically, docusa reference substance
Stock solution is prepared according to the following steps：(i) weigh 50mg and determined the docusa reference substance of moisture and be placed in
In 100mL volumetric flasks, (iii), which adds appropriate 50v% acetonitrile solutions shaking, makes its dissolving, and (iv) uses 50v% aqueous acetonitriles
Liquid is settled to 100mL.Docusa reference substance solution is prepared according to the following steps：(v) 5mL reference substance stock solutions are measured
It is placed in 50mL volumetric flasks, (vi) adds 50v% acetonitrile solutions and be settled to 50mL, and shaking makes its mixing.With reference to figure 4, more storehouses
It is noiseless between the characteristic peak and diluent peak and other miscellaneous peaks of ester calcium reference substance.
Embodiment 5
In the present embodiment, inventor obtains docusa to be measured by using cotton swab docusa process units
Sample solution.Specifically, selecting multiple sample points in docusa process units, the area of each sample point is 25 squares lis
Rice, it is distinguish between wherein each sample point matches somebody with somebody a vial and posts respective labels respectively, blank is put into vial
Cotton swab simultaneously adds 4.0mL diluent 50v% acetonitrile solutions, with blank cotton swab in each sample point by from left to right or from top to bottom
Direction is wiped, and has wiped and cotton swab is put into corresponding vial, and vial is sealed and is ultrasonically treated 5min, whirlpool successively
Rotation processing 1min, obtains docusa sample solution to be measured, has then measured docusa to be measured according to the description of conventional method
The HPLC collection of illustrative plates of sample solution, with reference to figure 5, because docusa soft capsule process units has cleaned up, no docusa remains,
Therefore docusa characteristic peak is not detected.
Embodiment 6
In the present embodiment, it is linear in the range of the μ g/mL of μ g/mL of concentration 10~200 to have investigated docusa by inventor.
Specifically, inventor has prepared 6 parts of docusa solution, concentration be respectively 10 μ g/mL, 25 μ g/mL, 40 μ g/mL, 50 μ g/mL,
100 μ g/mL and 200 μ g/mL, then determine its characteristic peak area according to the description of conventional method, and concentration is made with peak area
Figure, with reference to figure 6, docusa is linear good in the range of the μ g/mL of μ g/mL of concentration 10~200.
Embodiment 7
In the present embodiment, inventor has investigated the degree of accuracy of conventional method.Specifically, inventor adds in sample solution
Enter theoretical concentration (70 μ g/mL) 50%, 100% and 120% docusa solution, 3 parts of samples of each horizontal preparation, according to
The description of conventional method determines its docusa peak area and calculates average recovery rate, and the average recovery rate of 50% horizontal sample is
100.2%, the average recovery rate of 100% horizontal sample is 100.5%, and the average recovery rate of 120% horizontal sample is
100.6%, the relative standard deviation between 9 parts of varying level results is 0.7%, and the degree of accuracy is good
In the description of this specification, reference term " one embodiment ", " some embodiments ", " example ", " specifically show
The description of example " or " some examples " etc. means specific features, structure, material or the spy for combining the embodiment or example description
Point is contained at least one embodiment or example of the present invention.In this manual, to the schematic representation of above-mentioned term not
Identical embodiment or example must be directed to.Moreover, specific features, structure, material or the feature of description can be with office
Combined in an appropriate manner in one or more embodiments or example.In addition, in the case of not conflicting, the skill of this area
Art personnel can be tied the different embodiments or example and the feature of different embodiments or example described in this specification
Close and combine.
Although embodiments of the invention have been shown and described above, it is to be understood that above-described embodiment is example
Property, it is impossible to limitation of the present invention is interpreted as, one of ordinary skill in the art within the scope of the invention can be to above-mentioned
Embodiment is changed, changed, replacing and modification.
Claims (3)
- A kind of 1. method for detecting docusa soft capsule cleaning residual quantity, it is characterised in that including：Docusa to be measured is detected by HPLC methods, wherein, the condition of the HPLC methods is：HPLC chromatogram post：C18, 5 microns, 4.6 × 150 millimeters or equivalent post；Mobile phase：The mixed solution of the mol/L tetrabutyl ammonium hydrogen phosphate aqueous solution of 34 parts by volume 0.01 and 66 parts by volume of acetonitrile；Flow velocity：1.5 ml/min；Sample size：100 microlitres；Column temperature：30 degrees Celsius；Detection wavelength：214 nanometers.
- 2. according to the method for claim 1, it is characterised in that the docusa to be measured is production docusa soft capsule During remain in the docusa active pharmaceutical ingredient in process units.
- 3. the method according to right wants 2, it is characterised in that determined based on following formula described to be measured more on every 25 square centimeters of plates The amount of storehouse ester calcium：<mrow> <mi>A</mi> <mi>m</mi> <mi>o</mi> <mi>u</mi> <mi>n</mi> <mi>t</mi> <mo>=</mo> <mfrac> <mrow> <mi>A</mi> <mi>s</mi> <mi>p</mi> <mi>l</mi> </mrow> <mrow> <mi>A</mi> <mi>s</mi> <mi>t</mi> <mi>d</mi> </mrow> </mfrac> <mo>&times;</mo> <mfrac> <mrow> <mi>S</mi> <mi>t</mi> <mi>d</mi> <mi>w</mi> <mi>t</mi> </mrow> <mrow> <mn>100</mn> <mi>m</mi> <mi>L</mi> </mrow> </mfrac> <mo>&times;</mo> <mi>P</mi> <mo>&times;</mo> <mfrac> <mrow> <mn>5</mn> <mi>m</mi> <mi>L</mi> </mrow> <mrow> <mn>50</mn> <mi>m</mi> <mi>L</mi> </mrow> </mfrac> <mo>&times;</mo> <mfrac> <mrow> <mn>4</mn> <mi>m</mi> <mi>L</mi> </mrow> <mn>1</mn> </mfrac> <mo>&times;</mo> <mfrac> <mn>1</mn> <mrow> <mi>R</mi> <mi>F</mi> </mrow> </mfrac> <mo>&times;</mo> <mn>1000</mn> <mi>u</mi> <mi>g</mi> </mrow>Wherein, AsplRepresent the peak area of docusa sample to be measured in HPLC methods detection collection of illustrative plates；AstdRepresent the peak area of docusa reference substance in HPLC methods detection collection of illustrative plates；Std wt represent the sample weighting amount of docusa reference substance, and unit is milligram；P represents the purity of docusa in docusa reference substance, and unit is milligram/milligram；RF represents the average recovery rate of docusa.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110470746A (en) * | 2018-05-09 | 2019-11-19 | 人福普克药业（武汉）有限公司 | A method of detection calcitriol soft capsule cleans residual quantity |
| CN110487919A (en) * | 2018-05-14 | 2019-11-22 | 人福普克药业（武汉）有限公司 | A method of detection amantadine hydrochloride soft capsule cleans residual quantity |
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| CN110470746A (en) * | 2018-05-09 | 2019-11-19 | 人福普克药业（武汉）有限公司 | A method of detection calcitriol soft capsule cleans residual quantity |
| CN110487919A (en) * | 2018-05-14 | 2019-11-22 | 人福普克药业（武汉）有限公司 | A method of detection amantadine hydrochloride soft capsule cleans residual quantity |
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Application publication date: 20180309 |