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Method for detecting colored impurities in tigecycline for injection

A detection method, the technology of tigecycline, is applied in the direction of color/spectral characteristic measurement, measurement device, and material analysis through optical means, which can solve the problems of inaccurate detection results and provide accurate qualitative results

Inactive Publication Date: 2021-03-30
瀚晖制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The main purpose of the present invention is to provide a detection method for colored impurities in tigecycline for injection, to solve the problem of inaccurate detection results of the detection method for colored impurities in tigecycline in the prior art

Method used

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  • Method for detecting colored impurities in tigecycline for injection
  • Method for detecting colored impurities in tigecycline for injection
  • Method for detecting colored impurities in tigecycline for injection

Examples

Experimental program
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Effect test

Embodiment 1

[0034] Specific verification of wavelength absorption

[0035] Weigh an appropriate amount of tigecycline API and blank excipient (lactose) respectively according to the prescription amount, add purified water to dissolve and carry out full-wavelength scanning, see figure 1 and 2 . according to figure 1 and figure 2 It can be seen that tigecycline API and blank excipient (lactose) have no absorption in the range of 609-629nm, thereby avoiding the impact on the absorbance of tigecycline colored impurities.

[0036] The samples with different degrees of oxidation damage were used to screen the detection wavelength. In the tigecycline sample solution for injection containing tigecycline 10mg / ml (pure water is used as solvent), adding concentration is 1% hydrogen peroxide, and gained sample after different standing time see image 3 , scan the full wavelength of each sample, and the scanning results under various conditions are shown in Figure 4 . As time goes on, more an...

Embodiment 2

[0039] Verification of Absorption Wavelength

[0040] Three wavelengths of 609nm, 619nm, and 629nm were used to detect three batches of samples of tigecycline for injection, wherein water was used as a solvent, and the content of tigecycline for injection in the preparation was 10 mg / mL to be tested. The impurity absorbances of the three batches of samples to be tested are shown in Table 1.

[0041] Table 1

[0042]

[0043] It can be seen from Table 1 that the absorbance obtained by the three detection wavelengths fluctuates within the range of 0.002, and there is no significant difference from the specific values, and the results can be considered to be basically the same.

Embodiment 3

[0045] Validation of solvents

[0046] According to the usage and dosage requirements of the original preparation instructions, the samples were redissolved with purified water, 10% acetonitrile aqueous solution, 0.9% sodium chloride injection, 5% glucose injection and lactated Ringer's test respectively to form tigecycline for injection with a content of 10mg / mL of the sample to be tested, and then place each sample to be tested at room temperature for 6 hours to detect the impurity absorbance of the product, and the results are shown in Table 2.

[0047] Table 2

[0048]

[0049]

[0050] The data in Table 2 show that different compatible solvents do not affect the detection of the absorbance of impurities.

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Abstract

The invention provides a method for detecting colored impurities in tigecycline for injection. According to the detection method, whether tigecycline for injection contains colored impurities or not is detected by adopting an ultraviolet-visible spectrophotometry, and the detection wavelength used by the ultraviolet-visible spectrophotometry is 609-629 nm. The tigecycline colored impurity has remarkable absorption at the wavelength of 609-629 nm, and the difference between the absorption wavelength of the tigecycline colored impurity and the absorption wavelength of the tigecycline API is large, so that the influence of the tigecycline API can be avoided, and the accurate qualitative determination of the tigecycline colored impurity is further provided.

Description

technical field [0001] The invention relates to the field of drug analysis, in particular to a method for detecting colored impurities in tigecycline for injection. Background technique [0002] A patent (Patent No. US20090097026) published by Wyeth Corporation of the United States in 2009, the original manufacturer of tigecycline, studied the colored impurities of tigecycline. Experiment 5 of the patent example shows that the tigecycline solution is oxidatively degraded at room temperature to produce colored impurities, which are blue substances. Research shows that the colored impurities are not a single component, but a mixture of various substances, including at least Cyclocycline ring-opener. The API of tigecycline is orange, and the sample solution is green after visual observation of oxidative degradation. [0003] The colored impurity tigecycline ring-opened product can be obtained through degradation, separation and purification, and the production mechanism is as...

Claims

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Application Information

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IPC IPC(8): G01N21/31
CPCG01N21/3151G01N2021/3155
Inventor 徐慧娟杜加秋赵技宇易芬芬桂王艳张晓燕邵婷婷
Owner 瀚晖制药有限公司
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