CN106950290A - About the detection method of material in Clindamycin Phosphate Gel - Google Patents
About the detection method of material in Clindamycin Phosphate Gel Download PDFInfo
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- CN106950290A CN106950290A CN201611182189.6A CN201611182189A CN106950290A CN 106950290 A CN106950290 A CN 106950290A CN 201611182189 A CN201611182189 A CN 201611182189A CN 106950290 A CN106950290 A CN 106950290A
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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
Abstract
The present invention is the detection method about material in a kind of Clindamycin Phosphate Gel, pass through the screening of need testing solution preparation condition, the purification of gel pre-treatment, the screening of chromatographic condition, the detection method about material in Clindamycin Phosphate Gel is established, is shown by Method validation research：The method degree of accuracy set up is high, specificity is strong, repeatability is good, good tolerance, by the control in Clindamycin Phosphate Gel about material, the quality of raising product.
Description
Technical field
The present invention relates to the detection inspection technology field of medicine, have in more particularly to a kind of clindamycin phosphate ester gel
Close the detection method of material.
Background technology
Clindamycin Phosphate Gel is mainly used in the treatment of acne vulgaris.Clindamycin is in 1966 by Magerlerin
The hydroxyl of the 7th in lincomycin molecule is replaced to synthesize first Deng with chlorine.Clindamycin phosphate is semi-synthetic clindamycin
Derivative, in vitro without antibacterial activity, but with fat-soluble, Transdermal absorption is easy to compared with clindamycin, into rapid in vivo
It is hydrolyzed to clindamycin and shows antibacterial activity, its mechanism of action is by suppressing bacterioprotein early stage synthesis, so as to suppress
Bacillus acnes, and eliminate inflammation.
At present,《Chinese Pharmacopoeia》In only have the assay method of Determination of Clindamycin for Clindamycin Phosphate Gel, by
It is made up of in clindamycin phosphate ester gel the auxiliary material such as main ingredient clindamycin phosphate and lecithin, hydroxypropyl cellulose, its
Middle auxiliary material, impurity etc. affect the quality of Clindamycin Phosphate Gel, so, this simple content assaying method can not
Quality to clindamycin phosphate ester gel control effectively.Be therefore, the validity of guarantee clindamycin phosphate ester gel,
Security, makes the quality of clindamycin phosphate ester gel production process be effectively controlled, it is necessary to solidifying to clindamycin phosphate ester
Relevant material in glue is detected that this is also a kind of very necessary technological means of quality control.
The content of the invention
The purpose of the present invention is that the detection method provided in a kind of clindamycin phosphate ester gel about material, this
The detection method of limitation is conducive to controlling the quality of preparation, it is ensured that the validity of preparation.
The present invention adopts the following technical scheme that realization：
About the detection method of material in a kind of Clindamycin Phosphate Gel, it is characterised in that comprise the following steps：
A prepares need testing solution：It is 80 by Clindamycin Phosphate Gel volume ratio:20 phosphate buffer -90%
Acetonitrile methanol solution dissolves and the solution of 2~4mg containing clindamycin phosphate in every 1ml is made, and shakes up, and instills 3~5 and drips saturation
The ammonium tetrathiocyanodiaminochromate aqueous solution, shake, take supernatant to filter, take subsequent filtrate as need testing solution；
B prepares contrast solution：Precision measures above-mentioned need testing solution in right amount, is 80 with volume ratio:20 phosphate buffer-
90% acetonitrile methanol solution dissolves and the solution of 70~110ug containing clindamycin phosphate in every 1ml is made, molten as compareing
Liquid；
C prepares reference substance solution：Precision weighs clindamycin reference substance respectively and lincomycin reference substance is each appropriate, adds
Contrast solution made from stating b) process, which dissolves and quantifies dilution, to be made in every 1ml containing 20~40ug of clindamycin and lincomycin 4
~8ug mixed solution, is used as reference substance solution；
Above-mentioned need testing solution, contrast solution and reference substance solution are detected using high performance liquid chromatography, wherein
High-efficient liquid phase chromatogram condition is：
Chromatographic column：Octadecylsilane chemically bonded silica post,
Mobile phase A：Volume ratio is 92：The 8 acetonitrile methanol solution of phosphate buffer -90%,
Mobile phase B：Volume ratio is 52：The 48 acetonitrile methanol solution of phosphate buffer -90%,
Detection wavelength：210nm,
Column temperature：40 DEG C,
Flow velocity is 1.2ml per minute, is eluted in linear gradient elution mode.
The phosphate buffer pH is 3.9 ± 0.05；The phosphate buffer is to use phosphoric acid 3.5ml, and add water 1000ml
It is made with liquor ammoniae fortis 2.5ml.
The linear gradient elution mode such as following table：
| Time (minute) | Mobile phase A (%) | Mobile phase B (%) |
| 0 | 95 | 5 |
| 40 | 5 | 95 |
| 41 | 95 | 5 |
| 46 | 95 | 5 |
About the detection method of material in the Clindamycin Phosphate Gel of the present invention, pass through need testing solution preparation condition
Screening, the purification of gel pre-treatment, the screening of chromatographic condition, establish in Clindamycin Phosphate Gel relevant material
Detection method, is shown by Method validation research：The method degree of accuracy set up is high, specificity is strong, repeatability is good, durable
Property is good.The present invention is by the control in Clindamycin Phosphate Gel about material, improving the quality of product.
Brief description of the drawings
The need testing solution chromatogram that Fig. 1 provides for the present invention；
The reference substance chromatogram that Fig. 2 provides for the present invention；
Fig. 3 is clindamycin Line Chart；
Fig. 4 is lincomycin linear graph.
Embodiment
The present invention is explained with example, it should be understood that example is to be used to illustrate rather than to this below
The limitation of invention.The scope of the present invention is determined with core content according to claims.
Clindamycin Phosphate Gel derives from Ningxia Duowei Medicine Co., Ltd in following embodiments.
First, detection method
1st, the preparation of need testing solution：Precision measures Clindamycin Phosphate Gel in right amount, puts in 10ml measuring bottles, uses phosphoric acid
The acetonitrile methanol of buffer solution -90% solution (volume ratio 80:20) dissolve and be diluted to scale, phosphorus containing clindamycin in every 1ml is made
2~4mg of acid esters gel solution, shakes up, and 3~5 ammonium tetrathiocyanodiaminochromate aqueous solution for dripping saturation are added dropwise, shake, stands, takes supernatant to filter
Cross, take subsequent filtrate as need testing solution；Wherein phosphate buffer is to use phosphoric acid 3.5ml, and add water 1000ml and liquor ammoniae fortis
2.5ml is made, and adjusts pH value to 3.9 ± 0.05 with liquor ammoniae fortis if necessary.
2nd, the preparation of contrast solution：Precision measures need testing solution prepared by appropriate process 1, with diluent (phosphoric acid buffer
The acetonitrile methanol of liquid -90% solution (volume ratio 80:20)) 70~110ug containing clindamycin phosphate in every 1ml is made in quantitative dilution
Solution, be used as contrast solution.
3rd, the preparation of reference substance solution：Precision weighs clindamycin reference substance respectively and lincomycin reference substance is each appropriate,
Plus dissolve and quantify that dilution is made in every 1ml can be mould with woods containing 20~40ug of clindamycin for contrast solution made from said process 2
4~8ug of element mixed solution, is used as reference substance solution.
According to high performance liquid chromatography (general rule 0512) determine, with octadecylsilane chemically bonded silica be filler (4.6mm ×
250mm, 5um or the suitable chromatographic column of efficiency)；Mobile phase A is the acetonitrile methanol solution (92 of phosphate buffer (pH3.9) -90%：
8), Mobile phase B is the acetonitrile methanol solution (52 of phosphate buffer (pH3.9) -90%：48)；Detection wavelength is 210nm；Column temperature is
40℃；Flow velocity is 1.2ml per minute, and linear gradient elution is carried out by table 1.Precision measure need testing solution, reference substance solution with
Each 50ul of contrast solution, is injected separately into liquid chromatograph, records chromatogram.
Table 1：Linear gradient elution mode：
| Time (minute) | Mobile phase A (%) | Mobile phase B (%) |
| 0 | 95 | 5 |
| 40 | 5 | 95 |
| 41 | 95 | 5 |
| 46 | 95 | 5 |
If any the chromatographic peak consistent with clindamycin retention time with lincomycin in need testing solution chromatogram, its content
According to external standard method with calculated by peak area, the 0.5% and 2.0% of labelled amount must not be crossed respectively；Other single impurity (remove relative reservation
Time is less than outside 0.2 peak) peak area cannot be greater than 2/3 times (2.0%) of contrast solution main peak area, other impurities peak area
And cannot be greater than 2 times (6.0%) of contrast solution main peak area.It is less than contrast solution main peak face in need testing solution chromatogram
Ignore at the peak of 0.02 times of product.
It is that 160411,160412 batches of Clindamycin Phosphate Gels carry out relevant material inspection according to the method described above by lot number
Survey, as a result statistics such as table 2 below：
2nd, the pre-treatment of need testing solution --- the influence factor checking of the ammonium tetrathiocyanodiaminochromate aqueous solution is added dropwise
The ammonium tetrathiocyanodiaminochromate aqueous solution purification process of increase drop saturation in the pretreatment process of need testing solution, will be without this mistake
The need testing solution of journey and the need testing solution for having this process carry out filtration time contrast, relevant material testing result and contrasted, system
Meter such as table 3 below：
Understand from the above, plus the saturation Reinecke's salt aqueous solution is purified on the testing result about material without influence, and
The speed of filtering can be increased substantially, 5s/2ml is shorten to by original 2min/2ml, it is known that the purification of saturation Reinecke's salt is added dropwise
This step is feasible.
3rd, method validation data
1st, specificity is verified
Blank solvent (according to need testing solution preparation process, the mixed solution of diluent+Reinecke's salt), blank control is molten
(gel that other auxiliary materials in addition to active ingredient clindamycin phosphate are made, is made liquid according to need testing solution preparation method
Solution), mixed reference substance solution (clindamycin phosphate, clindamycin, lincomycin reference substance mixed solution), crin it is mould
Plain phosphoric acid gels need testing solution is distinguished fluid injection chromatography and detected, as a result blank solvent, placebo solution, mixing
Reference substance solution is noiseless to the measure of impurity, and specificity is good；Impurity separating degree is good, and peak shape is symmetrical, and detection method is feasible,
Meet detection to require.
2nd, linear verification
Precision weighs clindamycin, lincomycin reference substance in right amount, and concentration respectively clindamycin is made of diluent
100ug/ml, lincomycin 20ug/ml mixing reference substance stock solution.Mixing reference substance storing solution is diluted to 5 respectively
Concentration level, sample introduction in accordance with the law, using peak area as ordinate, solution concentration is abscissa, calculates regression equation, clindamycin recurrence side
Journey is y=2E+06x-2693.7r2=0.999, lincomycin regression equation is y=2E+07x+5256.3R2=0.9997.Examination
Test result to show, clindamycin is in the range of 0.0992~0.1050mg/ml, and in good linear relationship, lincomycin exists
In the range of 0.0011~0.0198mg/ml, in good linear relationship.
The relevant substance-measuring range of linearity of the clindamycin of table 4
The relevant substance-measuring range of linearity of the lincomycin of table 5
3rd, it is repeated
Same 6 parts of lot number test sample (lot number 160416) is taken, is determined according to relevant substance-measuring method.As a result average content
Respectively：Clindamycin 0.0406%, RSD is 1.21%, and lincomycin 0.0102%, RSD is 1.39%, maximum single miscellaneous average
Peak area is that 27278, RSD is 1.75%, and total miscellaneous average peak area is that 73145.RSD is 1.40%, and repeatability is good.
The relevant substance-measuring renaturation result of the test table of the clindamycin of table 6, lincomycin
| Numbering | 1 | 2 | 3 | 4 | 5 | 6 | It is average | RSD% |
| Determination of Clindamycin (%) | 0.0401 | 0.0407 | 0.0409 | 0.0400 | 0.0406 | 0.0413 | 0.0406 | 1.21 |
| Content of lincomycin (%) | 0.0102 | 0.0101 | 0.01 | 0.0102 | 0.0104 | 0.0103 | 0.0102 | 1.39 |
Other the unknown maximum single miscellaneous peak areas of table 7 and total miscellaneous peak area
| Numbering | 1 | 2 | 3 | 4 | 5 | 6 | It is average | RSD% |
| Maximum list miscellaneous peak area | 27842 | 27436 | 26954 | 27663 | 27224 | 26547 | 27278 | 1.75 |
| Total miscellaneous peak area | 74301 | 73458 | 74887 | 72542 | 73415 | 72145 | 73145 | 1.40 |
4th, stability of solution
Take with a need testing solution, from after preparing, by relevant substance-measuring method, respectively 0,2,4,6,8,12 hours
Sample introduction is determined.Results peaks area average is：Clindamycin average value is for 336003.097, RSD：0.95%；Lincomycin
Peak area average value is 1.37% for 154539.517, RSD；Maximum list miscellaneous peak area average is：27537.333, RSD are
1.65%, total miscellaneous peak area average is：72913.524, RSD be 0.76%.Show need testing solution from after preparing 12 hours
It is interior to determine basicly stable.
The clindamycin stability test result of table 8
The lincomycin stability test result of table 9
The maximum single miscellaneous stability test result of table 10
The gross area stability test result of table 11
Claims (4)
1. about the detection method of material in a kind of Clindamycin Phosphate Gel, it is characterised in that comprise the following steps：
A prepares need testing solution：It is 80 by Clindamycin Phosphate Gel volume ratio:The 20 acetonitrile first of phosphate buffer -90%
Alcoholic solution dissolves and the solution of 2~4mg containing clindamycin phosphate in every 1ml is made, and shakes up, and instills 3~5 Lei Shi for dripping saturation
Ammonium salt aqueous solution, shakes, takes supernatant to filter, take subsequent filtrate as need testing solution；
B prepares contrast solution：Precision measures above-mentioned need testing solution in right amount, is 80 with volume ratio:20 phosphate buffer -90%
Acetonitrile methanol solution dissolves and the solution of 70~110ug containing clindamycin phosphate in every 1ml is made, and is used as contrast solution；
C prepares reference substance solution：Precision weighs clindamycin reference substance respectively and lincomycin reference substance is each appropriate, adds and states
b）Contrast solution made from process dissolve and quantify dilution be made in every 1ml containing 20~40ug of clindamycin and lincomycin 4~
8ug mixed solution, is used as reference substance solution；
Above-mentioned need testing solution, contrast solution and reference substance solution are detected using high performance liquid chromatography, wherein efficiently
Liquid phase chromatogram condition is：
Chromatographic column：Octadecylsilane chemically bonded silica post,
Mobile phase A：Volume ratio is 92：The 8 acetonitrile methanol solution of phosphate buffer -90%,
Mobile phase B：Volume ratio is 52：The 48 acetonitrile methanol solution of phosphate buffer -90%,
Detection wavelength：210nm,
Column temperature：40 DEG C,
Flow velocity is 1.2ml per minute, is eluted in linear gradient elution mode.
2. according to the detection method in the Clindamycin Phosphate Gel described in claim 1 about material, it is characterised in that institute
It is 3.9 ± 0.05 to state phosphate buffer pH.
3. according to the detection method in the Clindamycin Phosphate Gel described in claim 1 or 2 about material, it is characterised in that
The phosphate buffer is to use phosphoric acid 3.5ml, the 1000ml and liquor ammoniae fortis 2.5ml that adds water to be made.
4. according to the detection method in the Clindamycin Phosphate Gel described in claim 1 about material, it is characterised in that institute
Stating linear gradient elution mode is, at 0 minute, according to mobile phase A：Mobile phase B=95:5 ratio elution, at 40 minutes, according to
Mobile phase A：Mobile phase B=5:95 ratio elution, at 41 minutes, according to mobile phase A：Mobile phase B=95:5 ratio elution, 46
During minute, according to mobile phase A：Mobile phase B=95:5 ratio elution.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108226324A (en) * | 2017-12-14 | 2018-06-29 | 兆科药业（广州）有限公司 | A kind of impurity control method of Clindamycin Hydrochloride |
| CN112684056A (en) * | 2020-12-30 | 2021-04-20 | 海南海神同洲制药有限公司 | Content determination method of clindamycin phosphate vaginal tablets |
| CN113092635A (en) * | 2021-03-19 | 2021-07-09 | 海南通用康力制药有限公司 | Quality detection method of clindamycin phosphate for injection |
| CN114224904A (en) * | 2021-12-17 | 2022-03-25 | 成都天台山制药有限公司 | Clindamycin phosphate and quality control method |
| CN114354810A (en) * | 2022-01-04 | 2022-04-15 | 武汉九州钰民医药科技有限公司 | Method for detecting impurity N in clindamycin phosphate and method for separating impurity |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SU588490A1 (en) * | 1975-07-28 | 1978-01-15 | Московский ордена Трудового Красного Знамени технологический институт пищевой промышленности | Method of quantitative determining of choline in a formulated feed |
| CN102062758A (en) * | 2009-11-18 | 2011-05-18 | 上海医药工业研究院 | Impurity analysis and preparation method for clindamycin phosphate |
| CN104374843A (en) * | 2014-11-11 | 2015-02-25 | 广东东阳光药业有限公司 | Method for simultaneously detecting methylparaben, propylparaben and dibutyl hydroxy toluene in gel |
| CN105092757A (en) * | 2015-08-06 | 2015-11-25 | 苏州二叶制药有限公司 | Clindamycin phosphate analysis method |
-
2016
- 2016-12-20 CN CN201611182189.6A patent/CN106950290B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SU588490A1 (en) * | 1975-07-28 | 1978-01-15 | Московский ордена Трудового Красного Знамени технологический институт пищевой промышленности | Method of quantitative determining of choline in a formulated feed |
| CN102062758A (en) * | 2009-11-18 | 2011-05-18 | 上海医药工业研究院 | Impurity analysis and preparation method for clindamycin phosphate |
| CN104374843A (en) * | 2014-11-11 | 2015-02-25 | 广东东阳光药业有限公司 | Method for simultaneously detecting methylparaben, propylparaben and dibutyl hydroxy toluene in gel |
| CN105092757A (en) * | 2015-08-06 | 2015-11-25 | 苏州二叶制药有限公司 | Clindamycin phosphate analysis method |
Non-Patent Citations (5)
| Title |
|---|
| J.A. ORWA ET AL.: "Liquid chromatography method for separation of clindamycin from related substances", 《JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS》 * |
| 国家药典委员会: "《中华人民共和国药典 2015年版二部》", 30 June 2015, 中国医药科技出版社 * |
| 夏振华 等: "克林霉素磷酸酯凝胶的HPLC测定", 《中国医药工业杂志》 * |
| 夏振华 等: "克林霉素磷酸酯及其有关物质USP测定方法的优化研究", 《抗感染药学》 * |
| 梁键谋 等: "HPLC梯度洗脱法检测克林霉素磷酸酯及其注射剂的有关物质", 《中国现代应用药学》 * |
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108226324A (en) * | 2017-12-14 | 2018-06-29 | 兆科药业（广州）有限公司 | A kind of impurity control method of Clindamycin Hydrochloride |
| CN108226324B (en) * | 2017-12-14 | 2021-01-12 | 兆科（广州）眼科药物有限公司 | Impurity control method of clindamycin hydrochloride |
| CN112684056A (en) * | 2020-12-30 | 2021-04-20 | 海南海神同洲制药有限公司 | Content determination method of clindamycin phosphate vaginal tablets |
| CN112684056B (en) * | 2020-12-30 | 2022-04-29 | 海南海神同洲制药有限公司 | Content determination method of clindamycin phosphate vaginal tablets |
| WO2022142152A1 (en) * | 2020-12-30 | 2022-07-07 | 海南海神同洲制药有限公司 | Content measurement method for clindamycin phosphate vaginal tablet |
| CN113092635A (en) * | 2021-03-19 | 2021-07-09 | 海南通用康力制药有限公司 | Quality detection method of clindamycin phosphate for injection |
| CN114224904A (en) * | 2021-12-17 | 2022-03-25 | 成都天台山制药有限公司 | Clindamycin phosphate and quality control method |
| CN114224904B (en) * | 2021-12-17 | 2024-03-08 | 成都天台山制药股份有限公司 | Clindamycin phosphate and quality control method |
| CN114354810A (en) * | 2022-01-04 | 2022-04-15 | 武汉九州钰民医药科技有限公司 | Method for detecting impurity N in clindamycin phosphate and method for separating impurity |
| CN114354810B (en) * | 2022-01-04 | 2024-04-19 | 武汉九州钰民医药科技有限公司 | Method for detecting impurity N in clindamycin phosphate and method for separating impurity |
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Address after: 750101 Telescope Development Zone, Yongning County, Yinchuan City, Ningxia Hui Autonomous Region Patentee after: Ningxia Zhouyang Pharmaceutical Co.,Ltd. Address before: 750101 Telescope Development Zone, Yongning County, Yinchuan City, Ningxia Hui Autonomous Region Patentee before: NINGXIA DUOWEI PHARMACEUTICAL Co.,Ltd. |