CN113552250A - Impurity detection method of cefozopran hydrochloride - Google Patents
Impurity detection method of cefozopran hydrochloride Download PDFInfo
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Abstract
The invention discloses an impurity detection method of cefozopran hydrochloride, and the chromatographic conditions comprise: an ACE Excel CN-ES chromatographic column is connected with a Waters Atlantis T3C18 chromatographic column in series; taking methanol and acetonitrile in a volume ratio of 20-30: 70-80 as a mobile phase A, and taking a triethylamine aqueous solution with a mass concentration of 0.3-0.5% as a mobile phase B; the volume ratio of the mobile phase A to the mobile phase B is 20-40: 60-80. By adopting the method, the resolution of each peak of the cefozopran hydrochloride raw material medicine is good, the resolution is more than 1.5, and the tailing factor is 0.8-1.2. The method is also suitable for detecting various damaged samples with more impurities, and is more favorable for quality monitoring of cefozopran hydrochloride.
Description
Technical Field
The invention belongs to the technical field of drug detection, and particularly relates to an impurity detection method of cefozopran hydrochloride.
Background
Cefozopran hydrochloride (cefozopran hydrochloride), also known as cefozopran hydrochloride, chemical name: [ [ (6R,7R) -7- [ (Z) -2- (5-amino-1, 2, 4-thiadiazol-3-yl) -2-methoxyiminoacetylamino ] -2-carboxy-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-en-3-yl ] methyl ] imidazo [1,2-b ] pyridazinium hydroxide inner salt monohydrochloride. Is a cephalosporin of the fourth generation, is a semi-synthetic and non-enteric cephalosporin, has wider antibacterial spectrum, is effective to gram-negative bacteria, gram-positive bacteria and pseudomonas aeruginosa, and is used for septicemia, traumatic wound infection and various infections caused by gram-positive bacteria, gram-negative bacteria and the like.
It is known that there are few reports on the impurity detection method of cefozopran hydrochloride. Related documents are known as 'determination of cefozopran hydrochloride content and related substances for injection by HPLC' (author Jiangsan), which establish a method for determining cefozopran hydrochloride content and related substances for injection by RP-HPLC. An Apollo C18 column is adopted, diethylamine acetic acid buffer solution-acetonitrile (100: 6) is taken as a mobile phase for impurity detection, and the result shows that the established method has strong specificity and reliable result, and can be used for content determination of cefozopran hydrochloride for injection and related substance examination. Although the main degradation product and the main drug of each damaged sample can be effectively separated, and the method has good specificity, the chromatogram shows that partial chromatographic peaks are mutually overlapped, particularly the impurity peaks of the oxidized damaged sample are overlapped, and the peak shape is poor, so that the method cannot reasonably and accurately detect the impurity content of the damaged sample with more impurity content.
Disclosure of Invention
In view of the defects of the prior art, the invention provides an impurity detection method of cefozopran hydrochloride.
The technical scheme of the invention mainly comprises the following contents:
the method for detecting impurities in cefozopran hydrochloride adopts high performance liquid chromatography for detection, and the chromatographic conditions comprise:
a chromatographic column: an ACE Excel CN-ES chromatographic column is connected with a Waters Atlantis T3C18 chromatographic column in series;
mobile phase: taking methanol and acetonitrile in a volume ratio of 20-30: 70-80 as a mobile phase A, and taking a triethylamine aqueous solution with a mass concentration of 0.3-0.5% as a mobile phase B; the volume ratio of the mobile phase A to the mobile phase B is 20-40: 60-80.
Preferably, the flow rate of the mobile phase is 1.0-1.5 mL/min.
Preferably, the column temperature is 25-35 ℃.
Preferably, the ACE Excel CN-ES chromatographic column has the length of 50mm, the inner diameter of 3.0mm and the packing particle size of 5 μm.
Preferably, the Waters Atlantis T3C18 chromatographic column has a length of 150mm, an inner diameter of 4.6mm and a filler particle size of 3 μm.
Preferably, the pH of the mobile phase B is 3.40-4.50.
Preferably, the pH is adjusted with glacial acetic acid.
The invention has the following effects:
the method comprises the steps of detecting impurities of cefozopran hydrochloride by high performance liquid chromatography, connecting an ACE Excel CN-ES chromatographic column and a Waters Atlantis T3C18 chromatographic column in series to serve as a stationary phase, taking a triethylamine aqueous solution with the mass concentration of 0.3-0.5% as a mobile phase A and taking methanol and acetonitrile in a volume ratio of 20-30: 70-80 as a mobile phase A; the volume ratio of the mobile phase A to the mobile phase B is 20-40: 60-80. By adopting the method, the resolution of each peak of the cefozopran hydrochloride raw material medicine is good, the resolution is more than 1.5, and the tailing factor is 0.8-1.2. The method is also suitable for detecting various damaged samples with more impurities. The method is more suitable for quality monitoring of cefozopran hydrochloride.
Detailed Description
In order to better understand the technical content of the invention, specific examples are provided below to further illustrate the invention.
Example 1-chromatographic conditions for detection of cefozopran hydrochloride impurity:
the instrument comprises the following steps: shimadzu liquid chromatograph
A chromatographic column: ACE Excel CN-ES column (50mm × 3.0mm, 5 μm) was connected in series with Waters Atlantis T3C18 column (150mm × 4.6mm, 3 μm);
mobile phase: taking methanol and acetonitrile in a volume ratio of 30:70 as a mobile phase A, taking a triethylamine aqueous solution with a mass concentration of 0.5% as a mobile phase B, and adjusting the pH value of the mobile phase B to 4.50 by using glacial acetic acid; the volume ratio of the mobile phase A to the mobile phase B is 40: 60.
the flow rate was 1.5 mL/min.
The detection wavelength is 254 nm.
The column temperature was 25 ℃.
Example 2-chromatographic conditions for detection of cefozopran hydrochloride impurities:
the instrument comprises the following steps: shimadzu liquid chromatograph
A chromatographic column: ACE Excel CN-ES column (50mm × 3.0mm, 5 μm) was connected in series with Waters Atlantis T3C18 column (150mm × 4.6mm, 3 μm);
mobile phase: taking methanol and acetonitrile in a volume ratio of 20:80 as a mobile phase A, taking a triethylamine aqueous solution with a mass concentration of 0.5% as a mobile phase B, and adjusting the pH value of the mobile phase B to 4.50 by using glacial acetic acid; the volume ratio of the mobile phase A to the mobile phase B is 20: 80.
the flow rate was 1.5 mL/min.
The detection wavelength is 254 nm.
The column temperature was 25 ℃.
Example 3-chromatographic conditions for detection of cefozopran hydrochloride impurities:
the instrument comprises the following steps: shimadzu liquid chromatograph
A chromatographic column: ACE Excel CN-ES column (50mm × 3.0mm, 5 μm) was connected in series with Waters Atlantis T3C18 column (150mm × 4.6mm, 3 μm);
mobile phase: taking methanol and acetonitrile in a volume ratio of 30:70 as a mobile phase A, taking a triethylamine aqueous solution with the mass concentration of 0.5% as a mobile phase B, and adjusting the pH value of the mobile phase B to 3.40 by using glacial acetic acid; the volume ratio of the mobile phase A to the mobile phase B is 40: 60.
the flow rate was 1.5 mL/min.
The detection wavelength is 254 nm.
The column temperature was 25 ℃.
Example 4-chromatographic conditions for detection of cefozopran hydrochloride impurities:
the instrument comprises the following steps: shimadzu liquid chromatograph
A chromatographic column: ACE Excel CN-ES column (50mm × 3.0mm, 5 μm) was connected in series with Waters Atlantis T3C18 column (150mm × 4.6mm, 3 μm);
mobile phase: taking methanol and acetonitrile in a volume ratio of 30:70 as a mobile phase A, taking a triethylamine aqueous solution with a mass concentration of 0.3% as a mobile phase B, and adjusting the pH value of the mobile phase B to 4.50 by using glacial acetic acid; the volume ratio of the mobile phase A to the mobile phase B is 40: 60.
the flow rate was 1.5 mL/min.
The detection wavelength is 254 nm.
The column temperature was 25 ℃.
Example 5-chromatography conditions for detection of cefozopran hydrochloride impurity:
the instrument comprises the following steps: shimadzu liquid chromatograph
A chromatographic column: ACE Excel CN-ES column (50mm × 3.0mm, 5 μm) was connected in series with Waters Atlantis T3C18 column (150mm × 4.6mm, 3 μm);
mobile phase: taking methanol and acetonitrile in a volume ratio of 30:70 as a mobile phase A, taking a triethylamine aqueous solution with a mass concentration of 0.5% as a mobile phase B, and adjusting the pH value of the mobile phase B to 5.50 by using glacial acetic acid; the volume ratio of the mobile phase A to the mobile phase B is 40: 60.
the flow rate was 1.5 mL/min.
The detection wavelength is 254 nm.
The column temperature was 25 ℃.
Example 6-chromatography conditions for detection of cefozopran hydrochloride impurity:
the instrument comprises the following steps: shimadzu liquid chromatograph
A chromatographic column: ACE Excel CN-ES column (50mm × 3.0mm, 5 μm) was connected in series with Waters Atlantis T3C18 column (150mm × 4.6mm, 3 μm);
mobile phase: taking methanol and acetonitrile in a volume ratio of 30:70 as a mobile phase A, taking a triethylamine aqueous solution with a mass concentration of 0.5% as a mobile phase B, and adjusting the pH value of the mobile phase B to 4.50 by using glacial acetic acid; the volume ratio of the mobile phase A to the mobile phase B is 40: 60.
the flow rate was 1.0 mL/min.
The detection wavelength is 254 nm.
The column temperature was 25 ℃.
Example 7-chromatography conditions for detection of cefozopran hydrochloride impurity:
the instrument comprises the following steps: shimadzu liquid chromatograph
A chromatographic column: ACE Excel CN-ES column (50mm × 3.0mm, 5 μm) was connected in series with Waters Atlantis T3C18 column (150mm × 4.6mm, 3 μm);
mobile phase: taking methanol and acetonitrile in a volume ratio of 30:70 as a mobile phase A, taking a triethylamine aqueous solution with a mass concentration of 0.5% as a mobile phase B, and adjusting the pH value of the mobile phase B to 4.50 by using glacial acetic acid; the volume ratio of the mobile phase A to the mobile phase B is 40: 60.
the flow rate was 1.5 mL/min.
The detection wavelength is 254 nm.
The column temperature was 35 ℃.
Example 8-chromatography conditions for detection of cefozopran hydrochloride impurity:
the instrument comprises the following steps: shimadzu liquid chromatograph
A chromatographic column: ACE Excel CN-ES column (50mm × 3.0mm, 5 μm) was connected in series with Waters Atlantis T3C18 column (150mm × 4.6mm, 3 μm);
mobile phase: taking methanol and acetonitrile in a volume ratio of 20-30: 70-80 as a mobile phase A, taking a triethylamine aqueous solution with a mass concentration of 0.3-0.5% as a mobile phase B, and adjusting the pH value of the mobile phase B to 3.40-4.50 by using glacial acetic acid; the volume ratio of the mobile phase A to the mobile phase B is 20-40: 60-80.
The flow rate is 1.0-1.5 mL/min.
The detection wavelength is 254 nm.
The column temperature was 40 ℃.
Comparative example 1-cefozopran hydrochloride impurity detection chromatographic conditions:
the instrument comprises the following steps: shimadzu liquid chromatograph
A chromatographic column: waters Atlantis T3C18 chromatography column (150 mm. times.4.6 mm, 3 μm);
mobile phase: taking methanol and acetonitrile in a volume ratio of 30:70 as a mobile phase A, taking a triethylamine aqueous solution with a mass concentration of 0.5% as a mobile phase B, and adjusting the pH value of the mobile phase B to 4.50 by using glacial acetic acid; the volume ratio of the mobile phase A to the mobile phase B is 40: 60.
the flow rate was 1.5 mL/min.
The detection wavelength is 254 nm.
The column temperature was 25 ℃.
Comparative example 2-chromatographic conditions for impurity detection of cefozopran hydrochloride:
the instrument comprises the following steps: shimadzu liquid chromatograph
A chromatographic column: ACE Excel CN-ES chromatography column (50mm × 3.0mm, 5 μm);
mobile phase: taking methanol and acetonitrile in a volume ratio of 30:70 as a mobile phase A, taking a triethylamine aqueous solution with a mass concentration of 0.5% as a mobile phase B, and adjusting the pH value of the mobile phase B to 4.50 by using glacial acetic acid; the volume ratio of the mobile phase A to the mobile phase B is 40: 60.
the flow rate was 1.5 mL/min.
The detection wavelength is 254 nm.
The column temperature was 25 ℃.
Comparative example 3-chromatographic conditions for impurity detection of cefozopran hydrochloride:
the instrument comprises the following steps: shimadzu liquid chromatograph
A chromatographic column: YMC-Triart C18 column (250 mm. times.4.6 mm, 5 μm);
mobile phase: taking methanol and acetonitrile in a volume ratio of 30:70 as a mobile phase A, taking a triethylamine aqueous solution with a mass concentration of 0.5% as a mobile phase B, and adjusting the pH value of the mobile phase B to 4.50 by using glacial acetic acid; the volume ratio of the mobile phase A to the mobile phase B is 40: 60.
the flow rate was 1.5 mL/min.
The detection wavelength is 254 nm.
The column temperature was 25 ℃.
Comparative example 4-cefozopran hydrochloride impurity detection chromatographic conditions:
the instrument comprises the following steps: shimadzu liquid chromatograph
A chromatographic column: ACE Excel CN-ES column (50mm × 3.0mm, 5 μm) was connected in series with Waters Atlantis T3C18 column (150mm × 4.6mm, 3 μm);
mobile phase: taking methanol and acetonitrile in a volume ratio of 30:70 as a mobile phase A, taking a triethylamine aqueous solution with a mass concentration of 0.1% as a mobile phase B, and adjusting the pH value of the mobile phase B to 4.50 by using glacial acetic acid; the volume ratio of the mobile phase A to the mobile phase B is 40: 60.
the flow rate was 1.5 mL/min.
The detection wavelength is 254 nm.
The column temperature was 25 ℃.
Comparative example 5-cefozopran hydrochloride impurity detection chromatographic conditions:
the instrument comprises the following steps: shimadzu liquid chromatograph
A chromatographic column: ACE Excel CN-ES column (50mm × 3.0mm, 5 μm) was connected in series with Waters Atlantis T3C18 column (150mm × 4.6mm, 3 μm);
mobile phase: taking methanol and acetonitrile in a volume ratio of 10:90 as a mobile phase A, taking a triethylamine aqueous solution with a mass concentration of 0.5% as a mobile phase B, and adjusting the pH value of the mobile phase B to 4.50 by using glacial acetic acid; the volume ratio of the mobile phase A to the mobile phase B is 10: 90.
the flow rate was 1.5 mL/min.
The detection wavelength is 254 nm.
The column temperature was 25 ℃.
And (3) detection effect:
samples to be tested are prepared, and impurity detection is carried out by adopting the chromatographic conditions of the above examples and comparative examples respectively, and the results are shown in table 2.
Table 1: sample to be tested
TABLE 2 degree of separation of adjacent peaks and tailing factor of peaks
Note: the upper row is the separation degree, and the lower row is the tailing factor
The results show that, by adopting the chromatographic conditions of the examples, the resolution of each peak of the cefozopran hydrochloride bulk drug is good, the resolution is greater than 1.5 (generally, the resolution is good when the resolution is greater than 1.5, and the impurity content can be accurately measured), the tailing factor is 0.8-1.2 (representing that the peak shape symmetry is good in the range), except for the examples 5 and 8, the resolution of each damaged sample reaches more than 1.7, and although the resolution is slightly poor when samples such as oxidative damage and the like are detected, the resolution still reaches more than 1.5, and the cefozopran hydrochloride bulk drug can still be used for detecting each bulk drug.
The comparative example 1 and the comparative example 2 are not connected in series, and a single chromatographic column cannot realize separation of chromatographic peaks, so that the peak shape is poor, and the chromatographic column cannot be used for detecting impurities.
Comparative example 3 although the degree of separation and tailing factor were good for the undamaged sample, no detection could be made for the oxidatively damaged sample. The chromatographic conditions of comparative example 4 and comparative example 5 are not suitable for the detection of the cefozopran hydrochloride bulk drug.
The above description is only exemplary of the present invention and should not be taken as limiting the invention, as any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (7)
1. The method for detecting impurities in cefozopran hydrochloride adopts high performance liquid chromatography for detection, and is characterized in that the chromatographic conditions comprise:
a chromatographic column: an ACE Excel CN-ES chromatographic column is connected with a Waters Atlantis T3C18 chromatographic column in series;
mobile phase: taking methanol and acetonitrile in a volume ratio of 20-30: 70-80 as a mobile phase A, and taking a triethylamine aqueous solution with a mass concentration of 0.3-0.5% as a mobile phase B; the volume ratio of the mobile phase A to the mobile phase B is 20-40: 60-80.
2. The method for detecting impurities in cefozopran hydrochloride according to claim 1, wherein the flow rate of the mobile phase is 1.0-1.5 mL/min.
3. The method for detecting impurities in cefozopran hydrochloride according to claim 1, wherein the column temperature is 25-35 ℃.
4. The method for detecting impurities in cefozopran hydrochloride according to claim 1, wherein the ACE Excel CN-ES chromatographic column has a length of 50mm, an inner diameter of 3.0mm, and a filler particle size of 5 μm.
5. The method for detecting impurities in cefozopran hydrochloride according to claim 1, wherein the length of the chromatographic column of Waters Atlantis T3C18 is 150mm, the inner diameter is 4.6mm, and the particle size of the packing is 3 μm.
6. The method for detecting impurities in cefozopran hydrochloride according to claim 1, wherein the pH of mobile phase B is 3.40-4.50.
7. The method for detecting impurities in cefozopran hydrochloride according to claim 6, wherein the pH is adjusted with glacial acetic acid.
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| CN202110741797.0A CN113552250A (en) | 2021-06-30 | 2021-06-30 | Impurity detection method of cefozopran hydrochloride |
| PCT/CN2021/139072 WO2023273210A1 (en) | 2021-06-30 | 2021-12-17 | Method for measuring impurities of cefozopran hydrochloride |
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| WO2023273210A1 (en) * | 2021-06-30 | 2023-01-05 | 海南海灵化学制药有限公司 | Method for measuring impurities of cefozopran hydrochloride |
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| JP2011520866A (en) * | 2008-05-14 | 2011-07-21 | オーキッド ケミカルズ アンド ファーマシューティカルズ リミテッド | Improved production method of cefozopran |
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