CN105467048A - Impurity detection method for lansoprazole-containing raw material medicine - Google Patents
Impurity detection method for lansoprazole-containing raw material medicine Download PDFInfo
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- 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
- G01N30/60—Construction of the column
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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
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- G01N2030/027—Liquid chromatography
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Abstract
The invention provides an impurity detection method for a lansoprazole-containing raw material medicine; the method comprises the specific steps: weighing the lansoprazole-containing raw material medicine, placing the lansoprazole-containing raw material medicine into a brown volumetric flask, adding methanol, and dissolving to obtain a test sample solution; measuring to take a proper amount of the test sample solution, and adding a mobile phase to obtain a control solution; weighing a proper amount of impurities A, B, D and E, adding methanol, dissolving and diluting to obtain a mixed impurity stock solution; additionally taking the mixed impurity stock solution, adding the test sample solution to be used as a system suitability solution, and carrying out liquid phase detection, wherein a peak appearing order of the impurities in chromatography is D, E, A, a lansoprazole principal component peak and B, and the retention time of the lansoprazole component peak is 10-13 min; additionally taking the control solution, carrying out liquid phase detection, and controlling the peak height of the lansoprazole component peak to be 10% of the full scale of a recorder; and then measuring to take the test sample solution, carrying out chromatographic detection, and thus completing the impurity detection of the lansoprazole-containing raw material medicine. The lansoprazole related substance determination method has an acetonitrile-water system newly developed, and the system relieves the bearing pressure of a chromatographic column and makes results more accurate.
Description
Technical field
The present invention relates to impurity of the drug detection method, specifically the determination of related substances method of lansoprazole bulk drug and preparation.
Technical background
Lansoprazole bulk drug is our company's independent development and produces, develop be used for clinical formulation have freeze drying powder injection (Lansoprazole for injecting), specification 30mg; Lansoprazole enteric-coated tablet specification 15mg. clinical indication is also had to be gastric ulcer, duodenal ulcer, reflux esophagitis, Zhuo-Ai (Zollinger-Ellison) syndrome (gastrinoma), the related substance that current pharmacopeia and pertinent literature record is high performance liquid chromatography
The determination of related substances method of the former declaration of our company is as follows
Chromatographic condition: be filling agent with octadecylsilane chemically bonded silica; Methanol-water-triethylamine-phosphoric acid (700:300:5:1.5) is mobile phase by phosphoric acid solution (1 → 10) adjust ph to 7.3; Determined wavelength is 284nm; Number of theoretical plate calculates should be not less than 1500 by Lansoprazole.Solution preparation takes sample (or preparation takes content appropriate (being about equivalent to Lansoprazole 50mg)), put in the brown measuring bottle of 25ml, dissolve with methyl alcohol and be diluted to scale, obtain need testing solution, separately measure need testing solution 1ml, add mobile phase and be diluted to 100ml, shake up, in contrast liquid.According to above-mentioned liquid phase chromatogram condition, get contrast solution 10 μ l, injection liquid chromatography, regulate detection sensitivity, make the peak height of major component chromatographic peak be 10% ~ 20% of registering instrument full scale; Precision measures need testing solution and each 10 μ l of contrast solution again, respectively injection liquid chromatography, and record chromatogram is to 2 times of major component peak retention time.Control of Impurities: if any impurity peaks in need testing solution chromatogram, single impurity peak area must not be greater than the half (0.5%) of the main peak area of contrast solution, each impurity peak area and, the main peak area (1%) of contrast solution must not be greater than.
Content determination: chromatographic condition is consistent with determination of related substances method
Solution preparation: take from sample preparation product and be about 50mg, accurately weighed, put in the brown measuring bottle of 25ml, add methyl alcohol and dissolve and to being diluted to scale, shake up, precision measures 2ml, puts in the brown measuring bottle of 25ml, is diluted to scale with mobile phase, shake up as need testing solution; Separately take Lansoprazole reference substance and be about 50mg, with method preparation reference substance solution.Precision measures above-mentioned test liquid and each 10 μ l of reference substance solution, injection liquid chromatography, record chromatogram; By external standard method with calculated by peak area, calculate by dry product, should 99.0% be not less than containing Lansoprazole.
Prior art defect
(1) methyl alcohol system viscosity is strong, and post pressure is up to 225bar, and the column length time bears high pressure, and post bed fillers can be caused to run off, and the degraded of post effect is fast, and chromatographic peak trails.
(2) determination of related substances test liquid concentration high (2.0mg/ml), chromatographic column has over capacity risk, major component peak symmetry is poor, the symmetrical factor at middle major component peak is that 2.30 (should be 0.95 ~ 1.05) are undesirable, and impurity D and E overlaps, impurity B and major component peak cannot baseline separation.System is undesirable, and the result of mensuration can be sayed without true parasexuality.
(3) control of l.o.i, maximum list assorted only 0.5%, total assorted only 1.0%, do not meet the relevant regulations of " technological guidance's principle of chemicals impurity research ", standard has to be hoisted.
(4) assay solution preparation: existing common laboratory balance energy precise, to 10mg, samples 50mg and adopts two steps to be diluted to mensuration concentration, complicated operation, it is large that multistep dilution can cause surveying result error.
Summary of the invention
According to running inconvenience above, the invention provides following improvement.
Content is consistent with the chromatographic condition of determination of related substances method
Chromatographic condition: be filling agent with octadecylsilane chemically bonded silica; Acetonitrile-water-triethylamine (400: 600: 1) is mobile phase by phosphoric acid solution (1 → 10) adjust ph to 7.3; Determined wavelength is 284nm; Number of theoretical plate calculates should be not less than 4000 by Lansoprazole.
The solution preparation of content determination: precision takes lansoprazole bulk drug 15mg (preparation takes content or fine powder is about equivalent to Lansoprazole 15mg), put in the brown measuring bottle of 100ml, add the ultrasonic 2min of mobile phase make dissolving and be diluted to scale, shake up as test liquid (preparation filtration); Another precision takes Lansoprazole GB reference substance 15mg, puts in the brown measuring bottle of 100ml, adds mobile phase appropriate, ultrasonic 2min dissolves and is diluted to scale, shakes up, in contrast product solution, precision measures each 10 μ l of above-mentioned two kinds of solution, injection liquid chromatography, record chromatogram; By external standard method with calculated by peak area, bulk drug is pressed dry product and is calculated, and should be not less than 99.0% containing Lansoprazole; Tablet and injection calculate by labelled amount and should be 95.0 ~ 105.0 containing Lansoprazole.
The solution preparation of determination of related substances method:
(1) take and be placed in brown measuring bottle containing lansoprazole bulk drug (powder formulation), add methyl alcohol dissolve and dilute that to make mass concentration be that the solution of 1mg/mL Lansoprazole is as need testing solution, (preparation need testing solution filters, and gets subsequent filtrate as need testing solution).
(2) measure need testing solution appropriate, adding that mobile phase is mixed with containing mass concentration is the solution solution in contrast of 1 μ g/mL Lansoprazole.
(3) impurity A 10mg, B40mg, D10mg, E10mg is taken respectively in the measuring bottle of same 100ml, add methyl alcohol dissolve and be diluted to scale, another precision measures 1.0ml and adds methanol dilution to 10ml, as poly-doped impurity storing solution, (described impurity A is 2-[(RS)-[[trimethyl 1 is oxidized 4-(2,2,2-trifluoro ethoxy) pyridine-2-yl] methyl] sulfinyl]-1H-benzimidazole; Described impurity B is 2-(((3-methyl-4 (2,2,2-trifluoro ethoxy)-2-pyridine radicals) methyl) sulfonyl)-1H-benzimidazole; Described impurity D is hydroxybenzimidazole; Described impurity E is mercaptobenzimidazole.)
(4) separately get 1ml poly-doped impurity storing solution to add test liquid and be diluted to 10ml as system suitability solution, according to the chromatographic condition under assay item, get system suitability solution 10 μ l, injection liquid chromatography, controlling impurity B becomes the degree of separation of swarming to be not less than 8.0 with Lansoprazole, in chromatogram, the peak sequence of each impurity is D, E, A, Lansoprazole major component peak, B, and Lansoprazole becomes swarming retention time to be that (more preferably Lansoprazole becomes swarming retention time to be 11min to 10-13min.)。
(5) separately get contrast solution 10ul injection liquid chromatography, regulate detection sensitivity, control Lansoprazole and become the peak height of swarming to be 10% of registering instrument full scale.
(6) measure need testing solution 10 μ l again, injection liquid chromatography, record chromatogram to Lansoprazole becomes 3.5 times of swarming retention time, can complete the defects inspecting containing lansoprazole bulk drug.
(7) result calculates: as aobvious impurity peaks in need testing solution collection of illustrative plates, and outside the solvent before deduction impurity D or auxiliary material peak, the peak area of impurity D, A must not cross 1 times (0.1%) of contrast liquid main peak area; Must not cross after the peak area of impurity E is multiplied by correction factor 0.4 1 times (0.1%) of contrast liquid main peak area; The peak area of impurity B must not cross 4 times (0.4%) of contrast liquid main peak area; Any unknown single must not mix 1 times (0.1%) contrasting liquid main peak area; All impurity peak area sums must not be crossed 5 times (0.5%) of contrast liquid main peak area.
In step (3), in described poly-doped impurity storing solution, the concentration of 2-[(RS)-[[trimethyl 1 is oxidized 4-(2,2,2-trifluoro ethoxy) pyridine-2-yl] methyl] sulfinyl]-1H-benzimidazole is 10 μ g/mL; The concentration of 2-(((3-methyl-4 (2,2,2-trifluoro ethoxy)-2-pyridine radicals) methyl) sulfonyl)-1H-benzimidazole is 40 μ g/mL; The concentration of hydroxybenzimidazole is 10 μ g/mL; The concentration of mercaptobenzimidazole is 10 μ g/mL.
Lansoprazole for injecting is comprised containing lansoprazole bulk drug; Oral Lansoprazole enteric-coated tablet.
Different according to formulation, Control of Impurities limit is shown in list 1.
Chart 1
Technical scheme of the present invention is adopted to have following beneficial effect:
(1) the acetonitrile-water system that Lansoprazole determination of related substances method is newly developed, what this system not only alleviated chromatographic column bears pressure (it is 123.2bar that system chromatographic column newly developed bears pressure).
(2) under system newly developed, the retention time of major component is about 11min, and peak type is more sharp-pointed, and symmetry good (symmetrical factor is 0.94), the separation between each impurity is all greater than 1.5, and system has obvious improvement.
(3) belongingness research has been carried out to the characteristic impurity in product, and according to route of administration (oral Lansoprazole enteric-coated tablet, Lansoprazole for injecting) difference, formulate the control limit meeting " technological guidance's principle of chemicals impurity research " and Products quality, standard is promoted, improve product quality, for the security of clinical application lays a solid foundation.
(4) simplify the solution preparation method of content determination, it is more convenient to operate, and result is more accurate.
Accompanying drawing explanation
Fig. 1 is the system suitability collection of illustrative plates under methyl alcohol system.
Fig. 2 is the test sample collection of illustrative plates under methyl alcohol system.
Fig. 3 is the system suitability collection of illustrative plates under acetonitrile system.
Fig. 4 is the test sample collection of illustrative plates under acetonitrile system.
Fig. 5 is the real figure of lansoprazole bulk drug related substance.
Fig. 6 is the real figure of Lansoprazole for injecting related substance.
Fig. 7 is the real figure of Lansoprazole enteric-coated tablet related substance.
Embodiment
Embodiment 1
For Lansoprazole for injecting, checked for impurities.
Precision takes Lansoprazole for injecting (preparation takes content or fine powder is about equivalent to 50mg in right amount), puts in the brown measuring bottle of 50ml, adds methyl alcohol and dissolves and be diluted to scale, shakes up (preparation filtration), gets subsequent filtrate as need testing solution.
It is appropriate that precision measures test liquid, adds mobile phase and be mixed with solution solution in contrast containing 1 μ g/mL Lansoprazole.
Precision takes impurity A, B, D, E are appropriate, add methyl alcohol to dissolve and dilute and make poly-doped impurity storing solution, in poly-doped impurity storing solution, the mass concentration of impurity A, B, D, E is respectively the poly-doped impurity storing solution of 10 μ g/mL, 40 μ g/mL, 10 μ g/mL, 10 μ g/mL.
Separately get 1ml poly-doped impurity storing solution to add test liquid and be diluted to 10ml as system suitability solution, according to the chromatographic condition method under assay item, get system suitability solution 10 μ l, injection liquid chromatography, impurity B becomes the degree of separation of swarming should be not less than 8.0 (in chromatogram, the peak sequence of each impurity is D, E, A, Lansoprazole major component, B) with Lansoprazole, Lansoprazole becomes swarming retention time to be 11min; Separately get contrast solution 10ul injection liquid chromatography, regulate detection sensitivity, make the peak height of major component chromatographic peak be 10% of registering instrument full scale; Precision measures need testing solution 10 μ l again, injection liquid chromatography, and record chromatogram to Lansoprazole becomes 3.5 times of swarming retention time.As aobvious impurity peaks in need testing solution collection of illustrative plates, outside the solvent before deduction impurity D or auxiliary material peak, the peak area of impurity D must not cross 2 times (0.2%) of contrast liquid main peak area; Must not cross after the peak area of impurity E is multiplied by correction factor 0.4 1 times (0.1%) of contrast liquid main peak area; The peak area of impurity D must not cross 1 times (0.1%) of contrast liquid main peak area; The peak area of impurity B must not cross 4 times (0.4%) of contrast liquid main peak area; Any unknown single must not mix 1 times (0.1%) contrasting liquid main peak area; All impurity peak area sums must not be crossed 6 times (0.6%) of contrast liquid main peak area.
Lansoprazole determination of related substances method our company newly developed has carried out comprehensive checking, and the quantitative limit of this impurity, linear, accuracy result are in table 2 under this systems.
Table 2 (Lansoprazole for injecting determination of related substances method the result gathers)
For embodying the science of Lansoprazole determination of related substances method newly developed, the strict and technology of Control of Impurities is perspective, gets test result and has carried out list and contrast and see chart 3; And get same system suitability solution and same batch sample and undertaken measuring contrast by two systems, see accompanying drawing spectrum 1-4;
The key parameter contrast of table 3 Lansoprazole determination of related substances method new-old system
Embodiment 2
Get lansoprazole bulk drug that our company produces, Lansoprazole for injecting, Lansoprazole enteric-coated tablet detect by determination method newly developed in accordance with the law, see real Fig. 5 ~ 7.
The real figure of Fig. 5 lansoprazole bulk drug related substance.
The real figure of Fig. 6 Lansoprazole for injecting related substance.
The real figure of Fig. 7 Lansoprazole enteric-coated tablet related substance.
Claims (5)
1., containing a method for detecting impurities for lansoprazole bulk drug, it is characterized in that, comprise the steps:
(1) take and be placed in brown measuring bottle containing lansoprazole bulk drug, add methyl alcohol and dissolve and be diluted to scale, shake up, filter, get subsequent filtrate as need testing solution;
(2) measure need testing solution appropriate, adding that mobile phase is mixed with containing mass concentration is the solution solution in contrast of 1 μ g/mL Lansoprazole;
(3) take impurity A, B, D, E are appropriate, add methyl alcohol to dissolve and dilute and make poly-doped impurity storing solution, described impurity A is 2-[(RS)-[[trimethyl 1 is oxidized 4-(2,2,2-trifluoro ethoxy) pyridine-2-yl] methyl] sulfinyl]-1H-benzimidazole; Described impurity B is 2-(((3-methyl-4 (2,2,2-trifluoro ethoxy)-2-pyridine radicals) methyl) sulfonyl)-1H-benzimidazole; Described impurity D is hydroxybenzimidazole; Described impurity E is mercaptobenzimidazole;
(4) separately get 1ml poly-doped impurity storing solution to add test liquid and be diluted to 10ml as system suitability solution, according to the chromatographic condition under assay item, get system suitability solution 10 μ l, injection liquid chromatography, controlling impurity B becomes the degree of separation of swarming to be not less than 8.0 with Lansoprazole, in chromatogram, the peak sequence of each impurity is D, E, A, Lansoprazole major component peak, B, and Lansoprazole becomes swarming retention time to be 10 ~ 13min;
(5) separately get contrast solution 10ul injection liquid chromatography, regulate detection sensitivity, control Lansoprazole and become the peak height of swarming to be 10% of registering instrument full scale;
(6) measure need testing solution 10 μ l again, injection liquid chromatography, record chromatogram to Lansoprazole becomes 3.5 times of swarming retention time, can complete the defects inspecting containing lansoprazole bulk drug.
2. the method for detecting impurities containing lansoprazole bulk drug according to claim 1, is characterized in that, chromatographic condition: be filling agent with octadecylsilane chemically bonded silica; Acetonitrile-water-triethylamine (400: 600: 1) is mobile phase by phosphoric acid solution (1 → 10) adjust ph to 7.3; Determined wavelength is 284nm; Number of theoretical plate calculates should be not less than 4000 by Lansoprazole.
3. the method for detecting impurities containing lansoprazole bulk drug according to claim 1, it is characterized in that, in step (3), in described poly-doped impurity storing solution, the concentration of 2-[(RS)-[[trimethyl 1 is oxidized 4-(2,2,2-trifluoro ethoxy) pyridine-2-yl] methyl] sulfinyl]-1H-benzimidazole is 10 μ g/mL; The concentration of 2-(((3-methyl-4 (2,2,2-trifluoro ethoxy)-2-pyridine radicals) methyl) sulfonyl)-1H-benzimidazole is 40 μ g/mL; The concentration of hydroxybenzimidazole is 10 μ g/mL; The concentration of mercaptobenzimidazole is 10 μ g/mL.
4. the method for detecting impurities containing lansoprazole bulk drug according to claim 1, it is characterized in that, in step (4), Lansoprazole becomes swarming retention time to be 11min.
5. the method for detecting impurities containing lansoprazole bulk drug according to claim 1, is characterized in that, comprise Lansoprazole for injecting containing lansoprazole bulk drug; Oral Lansoprazole enteric-coated tablet.
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Cited By (2)
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| CN112834627A (en) * | 2019-11-22 | 2021-05-25 | 扬子江药业集团有限公司 | Method for separating and measuring lansoprazole related substances for injection by high performance liquid chromatography |
| CN113358768A (en) * | 2021-05-08 | 2021-09-07 | 南京一诺医药科技有限公司 | Method for simultaneously detecting levorotatory lansoprazole and dextrorotatory lansoprazole in human plasma by HPLC-MS/MS combination |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109374778B (en) * | 2018-12-14 | 2021-08-10 | 长沙理工大学 | Method for determining organic impurities in 2-mercaptobenzimidazole |
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| CN113358768A (en) * | 2021-05-08 | 2021-09-07 | 南京一诺医药科技有限公司 | Method for simultaneously detecting levorotatory lansoprazole and dextrorotatory lansoprazole in human plasma by HPLC-MS/MS combination |
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