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Method for detecting related substances in pharmaceutical preparation containing citicoline sodium

A technology of citicoline sodium and a detection method, applied in the field of drug detection, can solve problems such as effective detection and separation of substances that cannot be used, and achieve the effects of good applicability, good durability, high accuracy and precision

Inactive Publication Date: 2019-04-05
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] After the samples of citicoline sodium and sodium chloride injection were destroyed by acid, alkali, oxidation, high temperature and light, the detection method of related substances in citicoline sodium and sodium chloride injection recorded in the 2015 edition was used to detect the The related substances were analyzed, and the results could not effectively detect and separate the related substances

Method used

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  • Method for detecting related substances in pharmaceutical preparation containing citicoline sodium
  • Method for detecting related substances in pharmaceutical preparation containing citicoline sodium
  • Method for detecting related substances in pharmaceutical preparation containing citicoline sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Instrument and chromatographic conditions:

[0024] Japan Shimadzu LC-20A; octadecylsilane bonded silica gel column (Ultimate XB-C18 250×4.6mm, 5μm); column temperature is 5℃; mobile phase is phosphate buffer [0.1mol / L diphosphate Potassium hydrogen solution and tetrabutylammonium solution (take 0.01mol / L tetrabutylammonium hydroxide solution and adjust the pH value to 5.2 with phosphoric acid) and mix in equal amounts]-methanol (95:5); flow rate 1.0ml / min; detection wavelength: 276nm ; Injection volume 10 μl.

[0025] experiment procedure:

[0026] Accurately weigh 15 mg each of 5'-cytidylic acid, urophosphorylcholine, cytosine, cytidine, uridine, and 5'-uridine reference substance, put them in 100ml measuring bottles, add water to dissolve and Dilute to the mark, shake well, and prepare the stock solution of each impurity reference substance; accurately weigh 0.1 g of the citicoline sodium reference substance, put it in a 100ml measuring bottle, accurately add 2ml e...

Embodiment 2

[0033] Change flow velocity (± 0.1ml / min), then according to the method for embodiment 1, need testing solution is detected, take the number of impurity in the chromatogram of record and the degree of separation of main component peak and adjacent impurity as index, investigate different The separation effect of flow rate in a chromatographic system. see results Figure 3 ~ Figure 4 and Table 1.

[0034] The detection result of the need testing solution of table 1 different flow rates

[0035] Flow rate (ml / min)

[0036] The above test results show that the number of detected impurities is consistent when the flow rate is in the range of 0.9-1.1ml / min, and the resolution of each impurity is above 1.5. In a preferred solution, the flow rate is 1.0ml / min.

Embodiment 3

[0038] Change the pH value of the mobile phase phosphate buffer, prepare phosphate buffer with different pH values, and then detect the solution of the test product according to the method of Example 1, and record the number of impurities in the chromatogram and the peak and phase of the main component. The separation degree of adjacent impurities was used as an index to investigate the separation effect of phosphate buffer with different pH values ​​in the chromatographic system. see results Figure 5 ~ Figure 6 and Table 2.

[0039] The detection result of the need testing solution of table 2 different pH value phosphate buffered saline

[0040] pH of Phosphate Buffer

[0041] The above test results show that when the pH of the mobile phase phosphate buffer is in the range of 5.0 to 5.2, the number of detected impurities is consistent, and the resolution of each impurity is above 1.5. In a preferred scheme, the pH of the mobile phase phosphate buffer is 5.2.

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Abstract

The invention relates to a method for detecting related substances in a pharmaceutical preparation containing citicoline sodium. High performance liquid chromatography is adopted to analyze a system applicability solution, and the separation degree and theoretical plate number of citicoline sodium peak among the citicoline sodium peak and adjacent impurities and each known impurity in a chromatogram are recorded; the separation degree among citicoline sodium and adjacent impurities and each known impurity is greater than 1.5, when the theoretical plate number of the citicoline peak is greaterthan 2000, then a test solution and a contrast solution are analyzed and detected, the chromatogram is recorded for three times of the retention time of a main component peak, and the impurity number,type, relative percentage content, peak area and separation degree between the peaks are read and calculated from the recorded chromatogram; and the peak area in the chromatogram is calculated to obtain the content of each impurity. Compared with the prior art, the method for detecting the related substances in the pharmaceutical preparation containing citicoline sodium is simple and convenient,quick and good in durability, the impurities in the citicoline sodium can be effectively detected, and the method for detecting the related substances in the pharmaceutical preparation containing citicoline sodium is good in applicability, and high in accuracy and precision.

Description

technical field [0001] The invention belongs to the technical field of drug detection, and in particular relates to a method for detecting related substances in a drug preparation containing citicoline sodium. Background technique [0002] The main ingredient of this product is citicoline sodium, and its chemical name is monosodium salt of choline cytosine nucleoside diphosphate. It is mainly used clinically for acute traumatic brain injury and disturbance of consciousness after brain surgery. Its chemical structural formula is as follows: [0003] [0004] The active ingredient of Citicoline Sodium Chloride Injection is Citicoline Sodium, and its chemical name is the monosodium salt of choline cytosine nucleoside diphosphate. Citicoline is a nucleoside derivative that can enhance the function of the brainstem reticular structure, especially the activation system of the ascending reticular structure closely related to consciousness; enhance the function of the pyramidal ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/60G01N30/86
CPCG01N30/02G01N30/60G01N30/8631G01N30/8679
Inventor 姜瑞玲别粉霞李贤王绍同
Owner CISEN PHARMA
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