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Method for detecting impurity N in clindamycin phosphate and method for separating impurity

A technology of clindamycin phosphate and detection method, applied in material separation, measurement device, analytical material and other directions, can solve problems such as separation and detection of difficult target impurities, achieve good peak shape and separation, meet detection, effective separation effect

Pending Publication Date: 2022-04-15
武汉九州钰民医药科技有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0009] The technical problem to be solved by the present invention is to overcome the defect that the detection method of clindamycin phosphate-related substances in the prior art is difficult to realize the separation and detection of target impurities; and a detection method for impurity N in clindamycin phosphate is provided , and the separation method of impurities

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  • Method for detecting impurity N in clindamycin phosphate and method for separating impurity
  • Method for detecting impurity N in clindamycin phosphate and method for separating impurity
  • Method for detecting impurity N in clindamycin phosphate and method for separating impurity

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Experimental program
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Effect test

Embodiment 1

[0094] Detection of Related Substances in Example 1 Clindamycin Phosphate-Impurity N

[0095] The following chromatographic conditions for impurity N inspection in clindamycin phosphate are adopted, and the method establishment process is as follows:

[0096] (1) Impurity N detection chromatographic conditions

[0097] Chromatographic column: Ultimate C18, 4.6×150mm, 5μm

[0098] Mobile phase A: pH5.5 phosphate buffer (take 3.5ml of phosphoric acid, add 1000ml of water, add 2.5ml of ammonia water, adjust the pH value to 5.5 with ammonia water)

[0099] Mobile phase B: acetonitrile-methanol (90:10)

[0100] Flow rate: 1.2mL / min

[0101] Detection wavelength: 214nm

[0102] Injection volume: 50μL

[0103] Column temperature: 40°C

[0104] Gradient elution method:

[0105]

[0106] The high performance liquid chromatogram that the detection method of embodiment 1 obtains is as image 3 As shown, the specific data are shown in Table 1 below, and it can be seen that the ...

Embodiment 2

[0109] Detection of Related Substances in Example 2 Clindamycin Phosphate-Impurity N

[0110] Mobile phase A in embodiment 2 is pH5.3 phosphate buffer (get phosphoric acid 3.5ml, add water 1000ml, add ammoniacal liquor 2.5ml, adjust pH value to 5.3 with ammoniacal liquor), other are all the same as embodiment 1.

[0111] The high performance liquid chromatogram that the detection method of embodiment 2 obtains is as Figure 4 As shown, the specific data are shown in Table 2 below, and it can be seen that the degree of separation is 4.6.

[0112] Table 2

[0113]

Embodiment 3

[0114] Detection of Related Substances in Example 3 Clindamycin Phosphate-Impurity N

[0115] Mobile phase A in embodiment 3 is pH5.7 phosphate buffer (get phosphoric acid 3.5ml, add water 1000ml, add ammoniacal liquor 2.5ml, adjust pH value to 5.7 with ammoniacal liquor), other are all the same as embodiment 1.

[0116] The high performance liquid chromatogram that the detection method of embodiment 3 obtains is as Figure 5 As shown, the specific data are shown in Table 3 below, and it can be seen that the degree of separation is 7.2.

[0117] table 3

[0118]

[0119]

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Abstract

The invention discloses a method for detecting an impurity N in clindamycin phosphate and a method for separating the impurity. The method for detecting the impurity N in the clindamycin phosphate comprises the following steps: detecting a test solution of a clindamycin phosphate-containing medicine by adopting high performance liquid chromatography; mobile phases of the high performance liquid chromatography comprise a mobile phase A and a mobile phase B, the mobile phase A is a phosphate buffer solution, and the pH value of the mobile phase A is 5.0-6.0; the mobile phase B is an acetonitrile-methanol solution, and the volume ratio of acetonitrile to methanol is 90: 10. According to the detection method disclosed by the invention, the impurity N in the clindamycin phosphate can be effectively separated, and the peak shape and the separation degree are good; according to the separation method, separation of multiple impurities in clindamycin phosphate can be achieved, the separation degree between adjacent impurity peaks meets the requirement, and detection of the impurities in clindamycin phosphate can be met.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a method for detecting impurity N in clindamycin phosphate and a method for separating the impurity. Background technique [0002] Clindamycin phosphate is a chemically semi-synthesized clindamycin derivative, which has no antibacterial activity in vitro. Only after entering the body can it be rapidly hydrolyzed into clindamycin to exert pharmacological effects. It is effective against Gram-positive cocci and anaerobic bacteria. It has strong antibacterial activity, and the currently listed dosage forms at home and abroad mainly include tablets, suppositories, gels and injections. [0003] Clindamycin phosphate is known to contain impurities A, B, C, E, F, G, L, I, N, O, and the specific structures of these impurities are as follows: [0004] [0005] [0006] [0007] Among them, impurity N is a degraded impurity with a control limit of 0.2%, which ha...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/86
Inventor 姚萌霞余艳平范昭泽刘均均张璐龚丹凤陈程胡仁军
Owner 武汉九州钰民医药科技有限公司
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