CN107315059A - The content assaying method of rifampin and its impurity in a kind of rifampicin capsules - Google Patents
The content assaying method of rifampin and its impurity in a kind of rifampicin capsules Download PDFInfo
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- CN107315059A CN107315059A CN201710595788.9A CN201710595788A CN107315059A CN 107315059 A CN107315059 A CN 107315059A CN 201710595788 A CN201710595788 A CN 201710595788A CN 107315059 A CN107315059 A CN 107315059A
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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
- G01N30/62—Detectors specially adapted therefor
- G01N30/74—Optical detectors
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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
- G01N30/86—Signal analysis
- G01N30/8624—Detection of slopes or peaks; baseline correction
- G01N30/8631—Peaks
- G01N30/8634—Peak quality criteria
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Abstract
The present invention relates to the content assaying method of rifampin and its impurity in a kind of rifampicin capsules, it the described method comprises the following steps：Step 1, the preparation of reference substance solution：Precision weighs rifampin reference substance in right amount, and precision weighs quinoid rifampin reference substance and N oxidation rifampin reference substances are each appropriate, plus acetonitrile (respectively about 10mg adds 1ml acetonitriles) makes dissolving；Step 2, the preparation of need testing solution：Take rifampicin capsules content appropriate, it is accurately weighed, plus a small amount of acetonitrile (about rifampin 10mg adds 1ml acetonitriles) dissolving；Step 3, determination method：Precision measures rifampin reference substance solution and each 5 μ l of need testing solution, high performance liquid chromatograph is injected separately into, chromatogram is recorded, according to chromatogram, rifampin and quinoid rifampin in rifampicin capsules content are calculated using peak area method, N aoxidizes the content of rifampin.
Description
Technical field：
The present invention relates to a kind of content of the middle active ingredient of pharmaceutical preparation and the content assaying method of impurity, more particularly to
The content assaying method of rifampin and its impurity in a kind of antituberculotic rifampicin capsules.
Background technology：
Rifampin is the semi-synthetic broad spectrum antibiotic of rifomycins, common name：Rifampin, English name：
RIFAMPICINTABLETS.Multiple pathogenic microorganisms are had antibacterial activity by antituberculotic.Rifampicin oral absorbs good,
1.5~4 hours blood concentration peakings after medication.This product combine with other anti-tubercular drugs for it is various it is lungy just control with it is multiple
Control, include the treatment of tubercular meningitis.
The method that prior art reports rifampin content in a variety of application rifampicin capsules by HPLC,
Such as following methods：Using LichrospherRP-8 posts, 0.075mol/L KH2PO4：Acetonitrile：Methanol=1：1：1 is mobile phase,
254nm detections,
Its assay method is：Rifampicin capsules 20 is taken, by the finely ground mixing of content, accurately weighs and (is approximately equivalent in right amount
Rifampin 30mg), put in 50ml measuring bottles, plus methanol dissolves and is diluted to scale, shakes up, filtering, discards primary filtrate, accurate measuring
Filtrate 5ml is put in 50ml volumetric flasks, plus mobile phase is diluted to scale, shakes up, and takes 10ul to inject hplc determination.
Another prior art reports following methods
Chromatographic condition is：Octyl group silane group silica gel is filler, and theoretical cam curve is calculated by rifampin peak to be not less than
1500.2.1 mobile phase：Methanol：Acetonitrile：0.075mol/L potassium dihydrogen phosphates：1.0mol/L citric acid soln=30：30：
36：4, Detection wavelength：254nm, column temperature：Room temperature
The preparation of reference substance solution：Precision weighs rifampin reference substance in right amount, is dissolved with acetonitrile and is quantitatively diluted to every 1mL
In solution containing about 0.08mg, as reference substance solution.
The preparation of need testing solution：Test sample is taken, accurately weighed, finely ground, precision is weighed (is approximately equivalent to rifampin in right amount
80mg), dissolved with acetonitrile and be quantitatively diluted to the solution in every 1mL containing about 0.8mg, filtered with 0.45 μm of filter membrane, precision is measured
Appropriate subsequent filtrate, the solution in every 1mL containing about 0.08mg, as need testing solution are quantitatively diluted to acetonitrile.
It is accurate respectively to draw reference substance solution and each 10mL of need testing solution, high performance liquid chromatograph is injected, is inhaled with ultraviolet
The peak area that detector determines rifampin (C43H58N4O12) at wavelength 254nm is received, its content is calculated.
Another prior art reports following methods
The content of rifampicin capsules by HPLC
It is prepared by solution:It is prepared by reference substance solution:Precision is weighed to dry to the rifampin and carbamazepine reference substance of constant weight and fitted
Amount, puts in 100mL measuring bottles, is dissolved with methanol respectively, obtain containing rifampin and Carbamazepine be respectively 0.25g/L with
0.15g/L reference substance solution.
It is prepared by need testing solution:Rifampicin capsules 20 is taken, content is poured out, is well mixed.Precision weighs (about phase in right amount
When in rifampin 80mg), put in 100mL measuring bottles, liquid feeding 5mL is put in 100mL measuring bottles, and scale is diluted to mobile phase, is shaken up,
Chromatographic condition:Chromatographic column:SphorisorbC18 posts (5m, 4mm 150mm)；Mobile phase:Methanol:0.02mol/L phosphorus
Acid dihydride potassium (75:25)；Examined at 280nm,
Determination method：Take the rifampicin capsules of different lot numbers to measure, calculate labelled amount.
Prior art the disadvantage is that, sensitivity accuracy is not high, stability is poor.
The content of the invention：
The present invention obtains the content assaying method of rifampin and its impurity in a kind of new rifampicin capsules, institute by screening
The method of stating comprises the following steps：
Step 1, the preparation of reference substance solution：Precision weighs rifampin reference substance in right amount, plus (about 10mg adds a small amount of acetonitrile
1ml acetonitriles) dissolving；Precision weighs quinoid rifampin reference substance and N- oxidation rifampin reference substances are each appropriate, plus acetonitrile is (respectively about
10mg adds 1ml acetonitriles) make dissolving；
Step 2, the preparation of need testing solution：Take rifampicin capsules content appropriate, it is accurately weighed, plus a small amount of acetonitrile is (about
Rifampin 10mg adds 1ml acetonitriles) dissolving；
Step 3, determination method：Precision measures rifampin reference substance solution and each 5 μ l of need testing solution, is injected separately into efficient liquid
Chromatography, records chromatogram, and according to chromatogram, rifampin and quinone in rifampicin capsules content are calculated using peak area method
Formula rifampin, N- aoxidizes the content of rifampin；
Wherein, the chromatographic condition of the high performance liquid chromatography is as follows：Using octyl silane group silica gel as filler；With
0.1% trifluoroacetic acid aqueous solution is mobile phase A, using acetonitrile as Mobile phase B, according to the form below elution；Detection wavelength is 254nm；Flow velocity
For 1.0ml/min；Column temperature is 30 DEG C
It is preferred that, method of the invention, step is as follows：
Step 1, the preparation of reference substance solution：Weigh quinoid rifampin reference substance and N- oxidation rifampin reference substances are each suitable
Amount, plus acetonitrile (respectively about 10mg adds 1ml acetonitriles) make dissolving, and with acetonitrile-water (1: 1), quantitatively dilution is made in every 1ml containing about quinoid
Rifampin about 40 μ g, N- oxidation rifampin about 40 μ g mixed solution；
Step 2, the preparation of rifampin reference substance solution：Precision weighs rifampin reference substance in right amount, plus a small amount of acetonitrile is (about
10mg adds 1ml acetonitriles) after dissolving, with acetonitrile-water (1: 1), quantitatively solution in every 1ml containing about 10 μ g is made in dilution, is used as sharp good fortune
Flat reference substance solution；
Step 3, the preparation of need testing solution：Face and use brand-new.Take this product content appropriate, it is accurately weighed, plus a small amount of acetonitrile
After (about rifampin 10mg adds 1ml acetonitriles) dissolving, with acetonitrile-water (1: 1), quantitatively dilution is made in every 1ml containing about rifampin 1mg
Solution, filtration, take subsequent filtrate, be used as need testing solution；
Step 4, determination method：Precision measures rifampin reference substance solution and each 5 μ l of need testing solution, is injected separately into liquid phase color
Spectrometer, records chromatogram.By external standard method with calculated by peak area rifampin content；
Wherein, the chromatographic condition of the high performance liquid chromatography is as follows：Using octyl silane group silica gel as filler；With
0.1% trifluoroacetic acid aqueous solution is mobile phase A, using acetonitrile as Mobile phase B, according to the form below elution；Detection wavelength is 254nm；Flow velocity
For 1.0ml/min；Column temperature is 30 DEG C,
The method of the present invention is obtained by screening, and screening process is as follows：
(1) using the method for Chinese Pharmacopoeia version in 2015：Using octyl silane group silica gel as filler (Waters
Symmetry C8,4.6 × 150mm, 3.5 μm), with methanol-acetonitrile -0.075mol/L potassium dihydrogen phosphate -1.0mol/L Chinese hollys
Rafter acid solution (30: 30: 36: 4) is mobile phase.The separation situation test of rifampin impurity is carried out, Fig. 1 is as a result seen.As a result show：It is miscellaneous
Quinoid rifampin and impurity A are unable to reach baseline separation in matter mixed solution.
(2) using USP40 method：Using octyl silane group silica gel as filler (Waters Symmetry C8,
4.6 × 150mm, 3.5 μm), it is high with water-acetonitrile-pH3.1 potassium dihydrogen phosphate -1.0mol/L citric acid solns -5.0mol/L
Sodium chlorate solution (51: 35: 10: 2: 2) is mobile phase, carries out the separation situation test of rifampin impurity, as a result sees Fig. 2.As a result show
Show：N- aoxidizes rifampin and 3- formyls Rifamycin Sodium and can not be sufficiently separated.
(3) method optimization 1：
Using octyl silane group silica gel as filler (Waters Symmetry C8,4.6 × 150mm, 3.5 μm)；With
0.1% trifluoroacetic acid aqueous solution is mobile phase A, using acetonitrile as Mobile phase B；Detection wavelength is 254nm；Flow velocity is 1.0ml/min；
Column temperature is 30 DEG C.Elution program is as follows：
Impurity separation situation test is carried out to rifampin using said determination method, Fig. 3 is as a result seen.As a result show：Quinoid
Rifampin and impurity A baseline separation, run time are longer, need to further optimize.
(4) method optimization 2：
Using octyl silane group silica gel as filler (Waters Symmetry C8,4.6 × 150mm, 3.5 μm)；With
0.1% trifluoroacetic acid aqueous solution is mobile phase A, using acetonitrile as Mobile phase B；Detection wavelength is 254nm；Flow velocity is 1.0ml/min；
Column temperature is 30 DEG C.Elution program is as follows：
Impurity separation situation test is carried out to rifampin using said determination method, Fig. 4 is as a result seen.As a result show：Quinoid
Rifampin and impurity A baseline separation, run time are moderate, but there is RRT=0.61 and 0.64 two impurity more than 0.6%
It can not be kept completely separate, and the bulk drug that existing bulk drug supplier provides can persistently have the two impurity, therefore chromatographic condition is still
Need to further it optimize.
(5) method optimization 3：
Using octyl silane group silica gel as filler (Agilent Zorbax Eclipse XDB C8,4.6*250mm,
5μm)；Using 0.1% trifluoroacetic acid aqueous solution as mobile phase A, using acetonitrile as Mobile phase B；Detection wavelength is 254nm；Flow velocity is
1.0ml/min；Column temperature is 30 DEG C.Elution program is as follows：
Impurity separation situation test is carried out to rifampin using said determination method, Fig. 5 is as a result seen.As a result show：RRT=
The impurity separating degree that two of 0.61 and 0.64 are more than 0.6% is respectively that 24 and 14 separation are good, and remaining impurity is also separated well,
But there is unknown impuritie to be separation before main peak, further optimization.
(6) method optimization 4：Using octyl silane group silica gel as filler (Agilent Eclipse Plus C8,4.6
× 250mm, 5 μm or similar nature)；Using 0.1% trifluoroacetic acid aqueous solution as mobile phase A, using acetonitrile as Mobile phase B；Detect ripple
A length of 254nm；Flow velocity is 1.0ml/min；Column temperature is 30 DEG C.Elution program is as follows：
Impurity separation situation test is carried out to rifampin using said determination method, Fig. 6 is as a result seen.As a result show：This
Under part, known impurities and unknown impuritie separation are all right in rifampin, and this method meets containing rifampin, contains rifampin
Rifampin assay in pharmaceutical composition.
Brief description of the drawings
Impurity separates situation under the conditions of 2015 editions rifampicin capsules of Fig. 1 Chinese Pharmacopoeias
Impurity separates situation under the conditions of USP40 editions rifampicin capsules of Fig. 2
Fig. 3 methods optimize 1 chromatogram
Fig. 4 methods optimize 2 chromatograms
Fig. 5 methods optimize 3 chromatograms
Rifampin impurity separation situation after the optimization of Fig. 6 methods
Embodiment：
The present invention is further illustrated by the following examples, but not as limitation of the present invention.
Embodiment 1
Step 1, the preparation of reference substance solution：Weigh quinoid rifampin reference substance and N- oxidation rifampin reference substances are each suitable
Amount, plus acetonitrile (respectively about 10mg adds 1ml acetonitriles) make dissolving, and with acetonitrile-water (1: 1), quantitatively dilution is made in every 1ml containing about quinoid
Rifampin about 40 μ g, N- oxidation rifampin about 40 μ g mixed solution；
Step 2, the preparation of rifampin reference substance solution：Precision weighs rifampin reference substance in right amount, plus a small amount of acetonitrile is (about
10mg adds 1ml acetonitriles) after dissolving, with acetonitrile-water (1: 1), quantitatively solution in every 1ml containing about 10 μ g is made in dilution, is used as sharp good fortune
Flat reference substance solution；
Step 3, the preparation of need testing solution：Face and use brand-new.Take this product content appropriate, it is accurately weighed, plus a small amount of acetonitrile
After (about rifampin 10mg adds 1ml acetonitriles) dissolving, with acetonitrile-water (1: 1), quantitatively dilution is made in every 1ml containing about rifampin 1mg
Solution, filtration, take subsequent filtrate, be used as need testing solution；
Step 4, determination method：Precision measures rifampin reference substance solution and each 5 μ l of need testing solution, is injected separately into liquid phase color
Spectrometer, records chromatogram.By external standard method with calculated by peak area rifampin content；
Wherein, the chromatographic condition of the high performance liquid chromatography is as follows：Using octyl silane group silica gel as filler；With
0.1% trifluoroacetic acid aqueous solution is mobile phase A, using acetonitrile as Mobile phase B, according to the form below elution；Detection wavelength is 254nm；Flow velocity
For 1.0ml/min；Column temperature is 30 DEG C,
4th, the scope of application：Rifampin, the pharmaceutical composition containing rifampin.
Claims (2)
1. the content assaying method of rifampin and its impurity, the described method comprises the following steps in a kind of rifampicin capsules：
Step 1, the preparation of reference substance solution：Precision weighs rifampin reference substance in right amount, plus (about 10mg adds 1ml second to a small amount of acetonitrile
Nitrile) dissolving；Precision weighs quinoid rifampin reference substance and N- oxidation rifampin reference substances are each appropriate, plus (respectively about 10mg adds acetonitrile
1ml acetonitriles) make dissolving；
Step 2, the preparation of need testing solution：Take rifampicin capsules content appropriate, it is accurately weighed, plus a small amount of acetonitrile (Yue Lifu
Flat 10mg adds 1ml acetonitriles) dissolving；
Step 3, determination method：Precision measures rifampin reference substance solution and each 5 μ l of need testing solution, is injected separately into high-efficient liquid phase color
Spectrometer, records chromatogram, and according to chromatogram, rifampin and quinoid profit in rifampicin capsules content are calculated using peak area method
Good fortune is put down, and N- aoxidizes the content of rifampin；
Wherein, the chromatographic condition of the high performance liquid chromatography is as follows：Using octyl silane group silica gel as filler；With 0.1%
Trifluoroacetic acid aqueous solution is mobile phase A, using acetonitrile as Mobile phase B, according to the form below elution；Detection wavelength is 254nm；Flow velocity is
1.0ml/min；Column temperature is 30 DEG C
2. according to the method described in claim 1, it is characterised in that step is as follows：
Step 1, the preparation of reference substance solution：Weigh quinoid rifampin reference substance and N- oxidation rifampin reference substances are each appropriate, plus
Acetonitrile (respectively about 10mg adds 1ml acetonitriles) makes dissolving, and with acetonitrile-water (1: 1), quantitatively dilution is made in every 1ml containing about quinoid rifampin
About 40 μ g, N- oxidation rifampins about 40 μ g mixed solution；
Step 2, the preparation of rifampin reference substance solution：Precision weighs rifampin reference substance in right amount, plus (about 10mg adds a small amount of acetonitrile
1ml acetonitriles) after dissolving, with acetonitrile-water (1: 1), quantitatively solution in every 1ml containing about 10 μ g is made in dilution, is compareed as rifampin
Product solution；
Step 3, the preparation of need testing solution：Face and use brand-new.Take this product content appropriate, it is accurately weighed, plus acetonitrile is (about sharp on a small quantity
The flat 10mg of good fortune adds 1ml acetonitriles) dissolving after, with acetonitrile-water (1: 1) quantitatively dilution be made in every 1ml it is molten containing about rifampin 1mg
Liquid, filtration, takes subsequent filtrate, is used as need testing solution；
Step 4, determination method：Precision measures rifampin reference substance solution and each 5 μ l of need testing solution, is injected separately into liquid chromatogram
Instrument, records chromatogram.By external standard method with calculated by peak area rifampin content；
Wherein, the chromatographic condition of the high performance liquid chromatography is as follows：Using octyl silane group silica gel as filler；With 0.1%
Trifluoroacetic acid aqueous solution is mobile phase A, using acetonitrile as Mobile phase B, according to the form below elution；Detection wavelength is 254nm；Flow velocity is
1.0ml/min；Column temperature is 30 DEG C,
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109580806A (en) * | 2018-11-09 | 2019-04-05 | 佛山科学技术学院 | One kind is for the remaining measuring method of rifampicin medicine in aquatic products |
| CN112022831A (en) * | 2020-09-04 | 2020-12-04 | 四川制药制剂有限公司 | Preparation method of rifampicin capsule |
| CN113109493A (en) * | 2021-04-14 | 2021-07-13 | 安徽万邦医药科技股份有限公司 | Method for measuring rifampicin in plasma by high performance liquid chromatography-mass spectrometry |
| CN113933399A (en) * | 2020-06-29 | 2022-01-14 | 重庆华邦制药有限公司 | Method for separating and detecting rifampicin and related impurities in rifampicin for injection |
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2017
- 2017-07-20 CN CN201710595788.9A patent/CN107315059B/en active Active
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109580806A (en) * | 2018-11-09 | 2019-04-05 | 佛山科学技术学院 | One kind is for the remaining measuring method of rifampicin medicine in aquatic products |
| CN113933399A (en) * | 2020-06-29 | 2022-01-14 | 重庆华邦制药有限公司 | Method for separating and detecting rifampicin and related impurities in rifampicin for injection |
| CN113933399B (en) * | 2020-06-29 | 2023-08-15 | 重庆华邦制药有限公司 | Method for separating and detecting rifampicin and related impurities in rifampicin for injection |
| CN112022831A (en) * | 2020-09-04 | 2020-12-04 | 四川制药制剂有限公司 | Preparation method of rifampicin capsule |
| CN113109493A (en) * | 2021-04-14 | 2021-07-13 | 安徽万邦医药科技股份有限公司 | Method for measuring rifampicin in plasma by high performance liquid chromatography-mass spectrometry |
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