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Method for controlling impurities of nifuratel vaginal tablet

A technology of nifuratel and control methods, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., and can solve the problems of low specificity and low sensitivity

Inactive Publication Date: 2019-06-04
ANHUI PIOM PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] An object of the present invention is to provide a method for controlling impurities in nifuratel vaginal tablets, which solves the technical defects of the existing method for controlling impurities in nifuratel vaginal tablets that are not specific and sensitive

Method used

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  • Method for controlling impurities of nifuratel vaginal tablet

Examples

Experimental program
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Effect test

Embodiment 1

[0028] A kind of impurity control method of nifuratel vaginal tablet, its chromatographic condition is as follows:

[0029] Chromatographic column: Thermo Scientific Hypersil GOLD 250×4.6mm, 5μm

[0030] Column temperature: 30°C

[0031] Injection volume: 20 μl

[0032] Detection wavelength: 210 nm

[0033] Flow rate: 1.0ml / min

[0034] Mobile phase: 0.02% ammonium carbonate solution: acetonitrile = 64:36, volume ratio

[0035] Sample concentration: 0.8 mg / ml

[0036] According to the above chromatographic conditions, the blank solution, nifuratel reference solution, 5-nitrofurfural diacetate reference solution, 5-nifuridazine reference solution, auxiliary material blank-30 days light solution, nifurate Inject one injection of Taier-30-day light solution and nifuratel+full excipients-30-day light solution.

[0037] The peak shapes of nifuratel, 5-nitrofurfural diacetate and 5-nifuridazine were all good, and the mutual separation was good. Therefore, the column is suitab...

Embodiment 2

[0039] A kind of impurity control method of nifuratel vaginal tablet, its chromatographic condition is as follows:

[0040] Chromatographic column: Thermo Scientific Hypersil GOLD 250×4.6mm, 5μm

[0041] Column temperature: 30°C

[0042] Injection volume: 20 μl

[0043] Detection wavelength: 260 nm

[0044] Flow rate: 1.0ml / min

[0045] Mobile phase: 0.02% ammonium carbonate solution: acetonitrile = 64:36, volume ratio

[0046] Sample concentration: 0.8 mg / ml

[0047] According to the results of Example 1, the blank of the excipient produces an interference peak at the retention time of the photodegradation impurity of nifuratel. Therefore, try to adjust the detection wavelength to avoid the appearance of interference peaks. When the detection wavelength was changed to 260nm, the blank of excipients did not produce interference peaks at the photodegradation impurities of nifuratel. At 210nm and 260nm, the impurity profile is consistent and the number of impurities is co...

Embodiment 3

[0049] A kind of impurity control method of nifuratel vaginal tablet, its chromatographic condition is as follows:

[0050] Chromatographic column: Thermo Scientific Hypersil GOLD 250×4.6mm, 5μm

[0051] Column temperature: 30°C

[0052] Injection volume: 20 μl

[0053] Detection wavelength: 260 nm

[0054] Flow rate: 1.0ml / min

[0055] Mobile phase system: Phase A: Phase B = 64:36, volume ratio

[0056] Phase A: 10 mM KH 2 PO 4 , adjust the pH to 3.00 with phosphoric acid

[0057] Phase B: Acetonitrile

[0058] Sample concentration: 1.0 mg / ml

[0059] When the sample concentration was adjusted to 1.0mg / ml, the quantitative limit of the method could reach 0.03%, and the retention times of nifuratel, 5-nitrofurfural diacetate and 5-nifuridazine were 9.4min, 13.2min and 20.9min, RRT were 1.00, 0.20 and 0.78, indicating that the specificity of the method was good.

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Abstract

The invention relates to the technical field of drug analysis, and in particular relates to a method for controlling impurities of a nifuratel vaginal tablet. The method is a gradient elution method with a detection wavelength of 260 nm. The mobile phase is phase A: a 9 to 11 mM KH2PO4 solution, and a potassium hydroxide aqueous solution is used to adjust pH. The volume ratio of phase B: acetonitrile: methanol is 18:82 to 22:78. The method provided by the invention can solve the problems of excipient interference and impurity separation at the same time, and can comprehensively and effectivelydetect the content of each impurity. An effective method is provided for impurity control of nifuratel in preparation. The method provides a basis for the formulation of preparation quality standards.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for controlling impurities of nifuratel vaginal tablets. Background technique [0002] Nifuratel vaginal tablet is a kind of anti-trichomonas drug, its main ingredient is nifuratel, the English name is Nifurtel, the preparation specification is 0.25g / tablet, it is used to treat the infection caused by bacteria, trichomonas, mold and candida. vulva, vaginal infection and leucorrhea increase and urinary system infection, digestive tract amoebiasis and giardiasis. [0003] Nifuratel, chemical name 5-[(methylthio)methyl]-3-[((5-nitro-2-furyl)methylene)amino]-2-oxazolidinone, molecular formula It is C10H11N3O5S, molecular weight 285.28, insoluble in water, soluble in N,N-dimethylformamide, more sensitive to light. [0004] Because nifuratel is sensitive to light, it is easy to decompose when exposed to light, which increases the degradation products. Therefore, it is ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 陶勇陈正晧刘月庆何辉玲徐翠萍汪素娟
Owner ANHUI PIOM PHARMA
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