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Clindamycin phosphate and quality control method

A technology for clindamycin phosphate and content, which is applied in chemical instruments and methods, measuring devices, pharmaceutical formulations, etc., and can solve problems such as risks caused by clinical use

Pending Publication Date: 2022-03-25
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, in the preparation process of clindamycin phosphate, there are still some possible impurities that have not been developed for detection, resulting in many unknown impurities in clindamycin phosphate, which pose risks to its clinical use
There is also currently no assay that is suitable for detecting more clindamycin phosphate impurities

Method used

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  • Clindamycin phosphate and quality control method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] Example 1. Detection of Clindamycin Phosphate Impurities Using Mobile Phases with Different pH Values

[0066] The detection method refers to USP43, but the pH value of its mobile phase is changed, and mobile phases with pH values ​​of 3.9, 5.0, 5.8 and 6.0 are used respectively. The detection results are shown in Table 4 and Figure 1~4 shown.

[0067] Table 4. Test results

[0068]

[0069] Results: The flow of different pH values ​​has a great influence on the separation of each component. When the pH is 6.0, the separation of all impurities can be guaranteed to meet the requirements, but under this pH condition, the impurity K does not peak within the running time.

Embodiment 2

[0070] Embodiment 2, the method for detecting clindamycin phosphate impurity A-L

[0071] According to the results of Example 1, a method for detecting the clindamycin phosphate impurity was found, which can detect the clindamycin phosphate impurity A-L. The detection method refers to USP43, and the chromatographic conditions are changed as follows, and the detection results are as follows: Figure 5 shown.

[0072] Chromatographic conditions: use octadecylsilane bonded silica gel as filler (4.6mm×250mm, 5μm or a chromatographic column with equivalent performance); use phosphate buffer (pH6.0)-90% acetonitrile methanol solution (92:8) Be mobile phase A, be mobile phase B with phosphate buffer (pH6.0)-90% acetonitrile methanol solution (52:48); Carry out linear gradient elution as shown in Table 5 below; Flow rate is 1.2ml per minute; Column temperature is 40°C; the detection wavelength is 214nm; the injection volume is 20μl.

[0073] Table 5. Elution conditions

[0074] ...

Embodiment 3

[0080] Embodiment 3, the method for detecting clindamycin phosphate impurity A-P

[0081] The mobile phase pH of the detection method described in Example 2 was adjusted to 5.96, the chromatographic column was replaced, and octylsilane bonded silica gel was used as a filler (Welch Ultimate XB-C8, 4.6mm×250mm, 5 μm), and the remaining chromatographic conditions and The detection method is the same as in Example 2. Detect impurity A-P, detection result is as table 7 and Figure 7 shown.

[0082] Table 7. Results of detection of impurities A-P

[0083]

[0084]

[0085] Using the above detection method, the minimum separation degree between impurities is 1.957, and impurities A-P can be effectively separated. It shows that the above detection method can effectively detect clindamycin phosphate impurity A-P at the same time.

[0086] The above-mentioned detection method formulates the detection standard of clindamycin phosphate as follows:

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Abstract

The invention provides high-purity clindamycin phosphate and a quality control method, and belongs to the field of medicines. The clindamycin phosphate comprises, by weight, less than or equal to 0.1% of a compound A, less than or equal to 1.0% of a compound B, less than or equal to 0.2% of a compound C, less than or equal to 0.5% of a compound E, less than or equal to 0.5% of a compound F, less than or equal to 0.2% of a compound G and less than or equal to 0.2% of a compound I, the weight percentage content of the compound J is less than or equal to 0.2%, the weight percentage content of the compound K is less than or equal to 0.2%, the weight percentage content of the compound L is less than or equal to 0.15%, and the weight percentage content of the compound M is less than or equal to 0.1%. According to the clindamycin phosphate impurity detection method provided by the invention, 16 impurities possibly existing in clindamycin phosphate can be effectively detected, the quality of clindamycin phosphate can be comprehensively evaluated, and the clindamycin phosphate impurity detection method is of great significance to quality control of clindamycin phosphate.

Description

technical field [0001] The invention belongs to the field of medicines, and in particular relates to clindamycin phosphate and a quality control method. Background technique [0002] Clindamycin phosphate is a semi-synthesized clindamycin derivative. It has no antibacterial activity in vitro, but it enters the body and is rapidly hydrolyzed into clindamycin to display its pharmacological activity. Therefore, the antibacterial spectrum, antibacterial activity and therapeutic effect are the same as clindamycin, but its fat solubility and permeability are better than clindamycin. It can be administered orally, intramuscularly or intravenously. It has strong antibacterial activity mainly against G+ cocci and anaerobic bacteria. Compared with lincomycin, its antibacterial effect is 4 to 8 times stronger, with better absorption, higher bone concentration and good curative effect on anaerobic infection. There are dosage forms such as aqueous injection, transfusion, injection, po...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7056C07H15/16C07H1/06A61P31/04G01N30/02G01N30/34G01N30/36G01N30/60
CPCA61K31/7056C07H15/16C07H1/06A61P31/04G01N30/02G01N30/34G01N30/36G01N30/6052A61K2300/00Y02A50/30
Inventor 王虎王宏升李昕琦齐海军江华
Owner CHENGDU TIANTAISHAN PHARMA
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