CN111044635A - Method for analyzing content of mecobalamin particles - Google Patents
Method for analyzing content of mecobalamin particles Download PDFInfo
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Abstract
The invention discloses an analysis method of mecobalamin particle content, which is characterized in that high performance liquid chromatography is combined with an ultraviolet detector for determination, a chromatographic column is a C18 chromatographic column, a mobile phase consists of water, a buffer solution and an organic solvent, and isocratic elution is set according to volume fraction; and performing quantitative analysis by using an external standard method. In the analysis method, the specification of a chromatographic column is 250 x 4.6mm and 5 mu m, the concentration of buffer salt in a mobile phase is 0.5 to 0.8mol/L, the pH value of the buffer salt is adjusted by an acid-base reagent, and the volume ratio of a buffer solution to an organic solvent is 3: 2 to 7: the detection wavelength of the 3 chromatographic column is 340nm to 344nm, the column temperature is 40 ℃, and the flow rate is 0.5ml/min to 1.0 ml/min. Through a series of examinations influencing chromatographic conditions, the inventor finds that the C18 chromatographic column can accurately detect the content of mecobalamin particles, and the precision and the reproducibility are good.
Description
FIELD
The invention relates to the technical field of pharmaceutical analysis, in particular to an analysis method of the content of mecobalamin particles.
Background
Mecobalamin is a coenzyme vitamin B12 type drug developed by Euonymus japonicus K.K., is a novel anti-anemia drug, and is used for treating diabetic peripheral nerve diseases and megaloblastic anemia caused by vitamin B12 deficiency, and peripheral nerve diseases. Compared with other vitamin B12 medicines, mecobalamin has good transferability in the nervous system; can promote the metabolism of nucleic acid, protein and fat; the damaged peripheral nerve is repaired by promoting the synthesis of nucleic acid and protein in nerve cells and the myelin sheath. Clinically, the traditional Chinese medicine composition has obvious effects on peripheral nerve diseases such as diabetic neuropathy, polyneuritis and the like, particularly on numbness, pain and paralysis, is an effective medicine for clinically treating the diseases at present, and has little side effect.
In order to ensure the subsequent development and production quality of mecobalamin, the quality of the raw material medicaments and the preparation thereof needs to be controlled. Therefore, the research for obtaining a detection method for measuring the content of mecobalamin is very urgent for pharmaceutical manufacturers. By consulting Chinese and foreign documents and patents, the existing detection method for net content of mecobalamin is single and is not beneficial to the control of enterprises on product quality, so that an analysis method for effectively determining the content of mecobalamin is urgently needed.
SUMMARY
The present disclosure relates to a method for analyzing the content of mecobalamin particles, comprising:
performing determination by high performance liquid chromatography, wherein the chromatographic column is C18 chromatographic column, the mobile phase consists of water, buffer solution and organic solvent, and isocratic elution is set according to volume fraction; and
quantitative analysis was performed by external standard method.
Brief description of the drawings
Fig. 1 shows a blank solution-water chromatogram of the present disclosure.
Fig. 2 shows a high performance liquid chromatogram of mecobalamin particles of example 1 of the present disclosure.
Fig. 3 shows a high performance liquid chromatogram of mecobalamin particles of example 2 of the present disclosure.
Fig. 4 shows a high performance liquid chromatogram of mecobalamin particles of example 3 of the present disclosure.
Detailed description of the invention
In the following description, certain specific details are included to provide a thorough understanding of various disclosed embodiments. One skilled in the relevant art will recognize, however, that the embodiments can be practiced without one or more of the specific details, or with other methods, components, materials, and so forth.
Unless otherwise required by the disclosure, throughout the specification and the appended claims, the words "comprise", "comprising", and "have" are to be construed in an open, inclusive sense, i.e., "including but not limited to".
Reference throughout the specification to "one embodiment," "an embodiment," "in another embodiment," or "in certain embodiments" means that a particular reference element, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" or "in another embodiment" or "in certain embodiments" in various places throughout this specification are not necessarily all referring to the same embodiment, and furthermore, particular elements, structures, or features may be combined in any suitable manner in one or more embodiments.
Definition of
In the present disclosure, the term "external standard method" refers to a method of quantifying by comparing response signals of a control substance and a component to be measured in a sample using a pure product of the component to be measured as the control substance.
In the present disclosure, the term "isocratic elution" refers to an elution pattern in which the composition and flow rate of a mobile phase are constant over an analysis cycle of a sample component.
Detailed Description
The present disclosure relates to a method for analyzing the content of mecobalamin particles, comprising:
performing determination by high performance liquid chromatography, wherein the chromatographic column is C18 chromatographic column, the mobile phase consists of water, buffer solution and organic solvent, and isocratic elution is set according to volume fraction; and
quantitative analysis was performed by external standard method.
In certain embodiments, further comprising the preparation of a pre-detection solution by reverse phase liquid chromatography, the solution comprising:
a blank solution selected from water;
the test solution consists of the mecobalamin particles and water; and
the reference solution is composed of mecobalamin reference and water.
In certain embodiments, the mecobalamin control is a pure mecobalamin substance.
In certain embodiments, the test solution is prepared at a light intensity of less than 5 lx.
In certain embodiments, the control solution is prepared at a light intensity of less than 5 lx.
In certain embodiments, the test solution has a concentration of 0.1 to 5 mg/ml.
In certain embodiments, the test solution has a concentration of 0.2 mg/ml.
In certain embodiments, the control solution has a concentration of 0.1 to 5 mg/ml.
In certain embodiments, the control solution has a concentration of 0.2 mg/ml.
In certain embodiments, the chromatography column is sized (250mm x 4.6mm,5 μm).
In certain embodiments, the buffer is comprised of a buffer salt and an acid-base reagent.
In certain embodiments, the buffering salt is selected from diammonium phosphate, potassium dihydrogen phosphate, disodium phosphate, or mixtures thereof.
In certain embodiments, the buffering salt is selected from disodium phosphate.
In certain embodiments, the acid agent is selected from phosphoric acid, hydrochloric acid, or mixtures thereof
In certain embodiments, the acid reagent is selected from phosphoric acid
In certain embodiments, the alkaline agent is sodium hydroxide, aqueous ammonia, or a mixture thereof
In certain embodiments, the alkaline agent is sodium hydroxide
In certain embodiments, the organic solvent is selected from methanol, ethanol, acetonitrile, or mixtures thereof.
In certain embodiments, the organic solvent is selected from methanol.
In certain embodiments, the concentration of the buffer salt in the mobile phase is from 0.5 to 0.8 mol/L.
In certain embodiments, the pH of the buffer salt in the mobile phase is between 3.0 and 4.0, and the pH of the buffer salt is adjusted by the acid-base reagent.
In certain embodiments, the volume ratio of buffer to organic solvent is 3: 2 to 7: 3.
in certain embodiments, the detection wavelength of the chromatography column is 340nm to 344 nm.
In certain embodiments, the flow rate of the chromatography column is from 0.5ml/min to 1.0 ml/min.
In certain embodiments, the column temperature of the chromatography column is from 35 ℃ to 45 ℃.
In certain embodiments, the column temperature of the chromatography column is 40 ℃.
In certain embodiments, the sample size of the chromatography column is from 20 μ L to 90 μ L.
In certain embodiments, the sample size of the column is 50 μ L.
Example 1
And (3) measuring the content of mecobalamin particles:
high performance liquid chromatography
Using an Acchrom Unit C18 column, a 250 x 4.6mm,5 μm or other equivalent performance column; the mobile phase is 0.01mol/L disodium hydrogen phosphate solution, and the pH is adjusted to 4.0-methanol (70:30) by phosphoric acid; the column temperature was 35 ℃; the detection wavelength is 342 nm; the flow rate was 1.0 ml/min.
The specific process is as follows:
preparation of test solution (operation in dark, light intensity less than 5 lx): taking a proper amount of mecobalamin particles, grinding, precisely weighing, adding water to dissolve and diluting to prepare a solution containing 0.2mg of mecobalamin particles in each 1 ml; ) (ii) a Preparation of control solution (operation in dark, light intensity less than 5 lx): taking a proper amount of mecobalamin standard substance, precisely weighing, adding water to dissolve and dilute into a solution containing 0.2mg of mecobalamin in each 1 ml. And (4) taking 50 mu l of each of the reference solution and the test solution, injecting into a liquid chromatograph according to the chromatographic conditions, and recording the chromatogram. The content is calculated according to an external standard method.
As shown in FIG. 1, the chromatogram of the blank solution is a horizontal straight line and no peak appears.
As shown in FIG. 2, which is a high performance liquid chromatogram of mecobalamin particles, the peak-appearance retention time of the mecobalamin particles is 12.588min, and the peak area is 7.8414.
The content formula is calculated by an external standard method:
au: peak area of test solution
As: peak area of control solution
And Vu: dilution factor of test solution
Vs: dilution factor of control solution
ms: reference substance weighing
P: content of control
LC: quantity of indication
N: number of sample bags
The concrete results are as follows:
wherein the peak area of the test solution is 7.8414, the dilution multiple of the test solution is 50, the sample weighing amount of the reference substance is 20.05mg, the content of the reference substance is 97.1%, the peak area of the reference solution is 7.7213, the dilution multiple of the reference substance is 100, the labeled amount is 0.5mg, and the number of sample bags is 20.
The content of mecobalamin particles is 98.9 percent calculated by an external standard method
Theoretical plate number calculation method:
N＝5.54(tR/W1/2)2
tR: time to peak of mecobalamin particles
W1/2: half peak width
Wherein, the retention time of the mecobalamin particles is 12.588min, and the half-peak width is 0.307.
System usability measurement results: the number of mecobalamin peak theoretical plates is 9301.
Example 2
Determination of the content of mecobalamin particles
High performance liquid chromatography
Using an Acchrom Unit C18 hydrophilic column, a 250 x 4.6mm,5 μm or other equivalent performance column; the mobile phase is 0.5mol/L disodium hydrogen phosphate solution, and the pH is adjusted to 3.0-methanol (65:35) by phosphoric acid; the column temperature was 40 ℃; the detection wavelength is 342 nm; the flow rate was 0.8ml/min
The specific process is as follows:
preparation of test solution (operation in dark, light intensity less than 5 lx): taking a proper amount of mecobalamin particles, grinding, precisely weighing, adding water to dissolve and diluting to prepare a solution containing 0.2mg of mecobalamin particles in each 1 ml; ) (ii) a Preparation of control solution (operation in dark, light intensity less than 5 lx): taking a proper amount of mecobalamin standard substance, precisely weighing, adding water to dissolve and dilute into a solution containing 0.2mg of mecobalamin in each 1 ml. And (4) taking 50 mu l of each of the reference solution and the test solution, injecting into a liquid chromatograph according to the chromatographic conditions, and recording the chromatogram. The content is calculated according to an external standard method.
As shown in FIG. 3, which is a high performance liquid chromatogram of mecobalamin particles, the peak-appearance retention time of the mecobalamin particles is 12.892min, and the peak area is 6.9774.
Au: peak area of test solution
As: peak area of control solution
And Vu: dilution factor of test solution
Vs: dilution factor of control solution
ms: reference substance weighing
P: content of control
LC: quantity of indication
N: number of sample bags
The concrete results are as follows:
wherein the peak area of the test solution is 6.9774, the dilution multiple of the test solution is 50, the sample weighing amount of the reference substance is 20.48mg, the content of the reference substance is 97.1%, the peak area of the reference solution is 7.1529, the dilution multiple of the reference substance is 100, the labeled amount is 0.5mg, and the number of sample bags is 20.
The content of mecobalamin particles calculated by an external standard method is 97.0 percent
Theoretical plate number calculation method:
N＝5.54(tR/W1/2)2
tR: time to peak of mecobalamin particles
W1/2: half peak width
Wherein, the retention time of the mecobalamin particles is 12.892min, and the half-peak width is 0.316.
System usability measurement results: the mecobalamin peak theoretical plate number is 9199.
Example 3
Determination of the content of mecobalamin particles
High performance liquid chromatography
Using an Agilent SB-C18 column, a 250 x 4.6mm,5 μm or equivalent column; the mobile phase is 0.5mol/L disodium hydrogen phosphate solution, and the pH is adjusted to 3.5-methanol (60:40) by phosphoric acid; the column temperature was 45 ℃; the detection wavelength is 342 nm; the flow rate was 0.5 ml/min.
The specific process is as follows:
preparation of test solution (operation in dark, light intensity less than 5 lx): taking a proper amount of mecobalamin particles, grinding, precisely weighing, adding water to dissolve and diluting to prepare a solution containing 0.2mg of mecobalamin particles in each 1 ml; ) (ii) a Preparation of control solution (operation in dark, light intensity less than 5 lx): taking a proper amount of mecobalamin standard substance, precisely weighing, adding water to dissolve and dilute into a solution containing 0.2mg of mecobalamin in each 1 ml. And (4) taking 50 mu l of each of the reference solution and the test solution, injecting into a liquid chromatograph according to the chromatographic conditions, and recording the chromatogram. The content is calculated according to an external standard method.
As shown in FIG. 4, which is a high performance liquid chromatogram of mecobalamin particles, the peak-appearance retention time of the mecobalamin particles is 13.020min, and the peak area is 7.5232.
Au: peak area of test solution
As: peak area of control solution
And Vu: dilution factor of test solution
Vs: dilution factor of control solution
ms: reference substance weighing
P: content of control
LC: quantity of indication
N: number of sample bags
The concrete results are as follows:
wherein the peak area of the test solution is 7.5232, the dilution multiple of the test solution is 50, the sample weighing amount of the reference substance is 20.23mg, the content of the reference substance is 97.1%, the peak area of the reference solution is 7.3894, the dilution multiple of the reference substance is 100, the labeled amount is 0.5mg, and the number of sample bags is 20.
The content of mecobalamin particles is 100.0 percent calculated by an external standard method
Theoretical plate number calculation method:
N＝5.54(tR/W1/2)2
tR: time to peak of mecobalamin particles
W1/2: half peak width
Wherein, the retention time of the mecobalamin particles is 13.020min, and the half-peak width is 0.323.
System usability measurement results: the number of mecobalamin peak theoretical plates was 8988.
From the foregoing it will be appreciated that, although specific embodiments of the disclosure have been described herein for purposes of illustration, various modifications or improvements may be made by those skilled in the art without departing from the spirit and scope of the disclosure, and that such modifications or improvements are intended to be within the scope of the appended claims.
Claims (8)
1. A method for analyzing the content of mecobalamin particles, comprising:
performing determination by high performance liquid chromatography, wherein the chromatographic column is C18 chromatographic column, the mobile phase consists of water, buffer solution and organic solvent, and isocratic elution is set according to volume fraction; and
quantitative analysis was performed by external standard method.
2. The assay of claim 1, further comprising preparation of a pre-liquid chromatography detection solution comprising:
a blank solution selected from water;
the test solution consists of the mecobalamin particles and water; and
a reference solution, which consists of a mecobalamin reference and water.
3. The assay of claim 1 or 2, wherein the test solution is prepared at a light intensity of less than 5lx and the control solution is prepared at a light intensity of less than 5 lx.
4. The assay of any one of claims 1 to 3, wherein the test solution concentration is 0.1 to 5mg/ml, preferably the test solution concentration is 0.2 mg/ml; the concentration of the control solution is 0.1 to 5mg/ml, and the concentration of the control solution is preferably 0.2 mg/ml.
5. The assay of claim 4, wherein: the buffer solution consists of a buffer salt and an acid-base reagent, wherein the buffer salt is selected from diammonium hydrogen phosphate, potassium dihydrogen phosphate, disodium hydrogen phosphate or a mixture thereof, and preferably the buffer salt is selected from disodium hydrogen phosphate; the acid reagent is selected from phosphoric acid, hydrochloric acid or a mixture thereof, preferably the acid reagent is phosphoric acid; the alkali reagent is selected from sodium hydroxide, ammonia water or a mixture thereof, and preferably the alkali reagent is sodium hydroxide; the organic solvent is selected from methanol, ethanol, acetonitrile or a mixture thereof, and preferably the organic solvent is selected from methanol.
6. The assay method of claim 4 or 5, wherein the concentration of the buffer salt in the mobile phase is 0.5 to 0.8mol/L and the pH of the buffer salt in the mobile phase is 3.0 to 4.0, preferably the pH of the buffer salt is adjusted by the acid-base reagent.
7. The assay of any one of claims 4 to 6, wherein the volume ratio of buffer to organic solvent is 3: 2 to 7: 3.
8. the assay of claim 7, wherein: the detection wavelength of the chromatographic column is 340nm to 344 nm; preferably the flow rate of the chromatographic column is from 0.5ml/min to 1.0 ml/min; the column temperature of the chromatographic column is 35 ℃ to 45 ℃, and preferably 40 ℃; the sample amount of the chromatographic column is 20-80 mu L, and preferably 50 mu L.
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| CN112630366A (en) * | 2020-12-18 | 2021-04-09 | 卓和药业集团有限公司 | High performance liquid chromatography detection method for content of mecobalamin dispersible tablets |
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Address after: 219 Furong Zhongsi Road, Xishan Economic and Technological Development Zone, Wuxi City, Jiangsu Province, 214000 Applicant after: Zhuohe Pharmaceutical Group Co.,Ltd. Address before: 219 Furong Zhongsi Road, Xishan Economic and Technological Development Zone, Wuxi City, Jiangsu Province, 214000 Applicant before: Zhuohe Pharmaceutical Group Co.,Ltd. |
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| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20200421 |