Detection method of related substances in sodium ozagrel and application

A technology for sodium ozagrel and a detection method, which is applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve the problems of nonconformity, large differences in the elution properties and absorption of impurities, and inability to detect

Active Publication Date: 2020-10-30
武汉九州钰民医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is too low for impurity detection, and the sensitivity of some impurities cannot be achieved;
[0005] 2) Some potential impurities cannot be separated or detected;
[0006] 3) Some impurities belong to low wavelength and cannot be detected;
[0007] 4) Control of non-specific impurities (known impurities), which does not meet the requirements of current impurity research
However, there are few references for the relevant substances of this product, and there are many impurities involved. The elution properties and absorption of impurities are very different, which brings difficulties to method development.

Method used

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  • Detection method of related substances in sodium ozagrel and application
  • Detection method of related substances in sodium ozagrel and application
  • Detection method of related substances in sodium ozagrel and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] Take an appropriate amount of this product, and use methanol-water (1:9) to make a solution containing about 0.2 mg per mL, as the test solution. Precisely pipette the test solution and dilute it 1000 times with methanol-water (1:9) as the control solution. Take an appropriate amount of Ozagrel impurity A reference substance, impurity B reference substance, Z-Ozagrel reference substance, AGSM01 reference substance, AG01 reference substance, impurity E reference substance, and Ozagrel reference substance, and use methanol-water (1:9 ) dissolved and diluted to make impurity A concentration about 1ug / mL, impurity B concentration about 1ug / mL, Z-Ozagrel concentration about 1ug / mL, AGSM01 concentration about 1ug / mL, AG01 concentration about 1ug / mL , impurity E concentration of about 1ug / mL, ozagrel concentration of about 1ug / mL solution, as the system suitability solution.

[0067] Use ACE Excel 5C18-PFP (150*4.6mm, 5um), column temperature 30°C, detection wavelength 272nm,...

Embodiment 2

[0077] (1) Quantitation limit and detection limit

[0078] The concentration limit of impurity B is 0.02457ug / mL, which is equivalent to 0.0123% of the sample concentration; the detection limit concentration is 0.01229ug / mL, which is equivalent to 0.0061% of the sample concentration.

[0079] The concentration limit of impurity A is 0.06144ug / mL, which is equivalent to 0.0307% of the sample concentration; the detection limit concentration is 0.03072ug / mL, which is equivalent to 0.0154% of the sample concentration.

[0080] The concentration limit of Z-Ozagrel is 0.03780ug / mL, which is equivalent to 0.0189% of the sample concentration; the limit concentration of detection is 0.01890ug / mL, which is equivalent to 0.0094% of the sample concentration.

[0081] (2) Linearity and range

[0082] Linear stock solution: Mix all the stock solutions, dilute with methanol-water (1:9) to make a solution containing about 10ug of each component per 1mL, as the linear stock solution.

[0083...

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Abstract

The invention discloses a detection method of related substances in sodium ozagrel and application of. The detection method of related substances in ozagrel sodium comprises the following step of: separating and detecting related substances in o sodium zagrel crude drugs or preparations by adopting chromatography, the related substances being one or more of an ozagrel impurity A, an ozagrel impurity B and Z-ozagrel, the chromatographic column being an octadecylsilane chemically bonded silica type chromatographic column, the detection wavelengths being 272 nm and 220 nm, a 0.3% ammonium acetatesolution being used as a mobile phase A, and methanol being used as a mobile phase B. According to the detection method of the sodium ozagrel, impurities in the sodium ozagrel can be effectively separated, the peak shape and the separation degree are good, and detection of the impurities in the sodium ozagrel can be met. Quantitative detection of the impurity A, the impurity B and the Z-ozagrel is achieved.

Description

technical field [0001] The invention relates to a detection method and application of related substances of ozagrel sodium. Background technique [0002] At present, sodium ozagrel (AG for short) is recorded in the 2015 edition of Chinese Pharmacopoeia (page 1404-1405 of the second part), and the impurities in sodium ozagrel are detected by the isocratic elution method. The specific detection method for related substances is: use The C18 chromatographic column is eluted with 0.3% ammonium acetate-methanol (80:20) as the flow equivalence, the flow rate is 1.0mL / min, and the detection wavelength is 272nm (see Chinese Pharmacopoeia 2015 Edition, Part Two, pages 1404-1405). [0003] Disadvantages of this program: [0004] 1) Sample concentration 0.05mg / mL. It is too low for impurity detection, and the sensitivity of some impurities cannot be achieved; [0005] 2) Some potential impurities cannot be separated or detected; [0006] 3) Some impurities belong to low wavelength a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74G01N30/86
CPCG01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74G01N30/8675G01N2030/324
Inventor 刘松林许勇范昭泽顿伟
Owner 武汉九州钰民医药科技有限公司
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