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Detection methods of fosaprepitant dimeglumine raw material or preparation and impurity in fosaprepitant dimeglumine raw material or preparation

A detection method, the technology of fosaprepitant, applied in the direction of measuring device, material separation, analysis of materials, etc., can solve the problem of no detection method, affecting the quality of fosaprepitant dimeglumine, and the drug safety of patients, to achieve strong specific effect

Inactive Publication Date: 2018-06-05
CHENGDU BAIYU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The technical effect of this patented process for detecting phosphorus (P) compounds by comparing them against different methods has been found that they are very selective towards certain chemicals but also can be detected without any other substances from those being tested or analyzed. This means there may exist many more types of P-compound than expected due to factors like environmental concerns such as acid rain.

Problems solved by technology

This patented technical problem addressed in this patents relates to improving the purity and stability of certain drugs like fuzopiridium didemilutei monohydrate that can cause side effects such as dyspepsia when given systemically at higher doses compared with other similar compounds without causing these adverse events.

Method used

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  • Detection methods of fosaprepitant dimeglumine raw material or preparation and impurity in fosaprepitant dimeglumine raw material or preparation
  • Detection methods of fosaprepitant dimeglumine raw material or preparation and impurity in fosaprepitant dimeglumine raw material or preparation
  • Detection methods of fosaprepitant dimeglumine raw material or preparation and impurity in fosaprepitant dimeglumine raw material or preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0070] Use the following steps to detect:

[0071] (1) Take the reference substances of impurities A, B, C, D, E, F, and G respectively, mix acetonitrile and water with a volume ratio of 50:50, and dissolve these reference substances as a solvent, and prepare each 1mL containing impurities 5 μg of standard control solution;

[0072] (2) Take a sample of fosaprepitant dimeglumine, mix acetonitrile and water at a volume ratio of 50:50 and dissolve the sample as a solvent, and prepare a sample solution containing about 1.0 mg of the sample per 1 mL;

[0073] (3) Take part of the sample solution prepared in step (2) and part of the standard control solution of impurities A, B, C, D, E, F, G prepared in step (1), and mix the two evenly After obtaining the contrast sample solution;

[0074](4) Perform HPLC detection on the obtained standard control solution, sample solution and comparison sample solution according to the following conditions, and record the chromatogram:

[0075]...

Embodiment 2

[0090] Use the following steps to detect:

[0091] (1) Take the reference substances of impurities A, B, C, D, E, F, G and fosaprepitant dipeglumine samples, mix acetonitrile and water with a volume ratio of 50:50 and dissolve them as a solvent to prepare Prepare the sample solution with Fosaprepitant Diglumine containing approximately 0.5 mg of impurities A, B, C, D, E, F, G and 1.0 mg of Fosaprepitant Diglumine sample per 1 mL;

[0092] (2) The obtained fosaprepitant dimeglumine prepared sample solution was subjected to HPLC detection according to the following conditions, and the chromatogram was recorded:

[0093] Chromatographic column: ACE C 18 , 4.6mm×250mm, 5µm;

[0094] Column temperature: 30°C; detection wavelength: 215nm;

[0095] Injection volume: 20 μL.

[0096] Mobile phase: 20mM ammonium dihydrogen phosphate buffer adjusted to pH 2.2 with phosphoric acid as mobile phase A, acetonitrile as mobile phase B, flow rate: 1.0ml / min;

[0097] Carry out gradient elu...

Embodiment 3

[0116] Example 3 Example of wavelength selection

[0117] Take a sample of fosaprepitant dipglumine, dissolve it with a solvent and dilute it to make a solution with a suitable concentration, and perform a spectral scan in the range of 200-400 nm according to the ultraviolet-visible spectrophotometry (Appendix IVA, Part Two of the Chinese Pharmacopoeia 2010 Edition), get attached Figure 12 The ultraviolet spectrogram shown shows that each impurity has a large absorption at 264 ± 3nm and the end region, and the absorption of each impurity at 264 ± 3nm is small, so 210nm and 215nm are selected for further comparison tests in the end region, and selected 215nm is used as the optimal wavelength.

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Abstract

The invention discloses detection methods of a fosaprepitant dimeglumine raw material or preparation and an impurity in fosaprepitant dimeglumine raw material or preparation. According to the detection methods, a sample solution of the fosaprepitant dimeglumine raw material or preparation is detected and analyzed by using high efficiency liquid chromatography; an immobile phase of a chromatographic column used for detection is octadecyl silane bonded silica gel; a mobile phase comprises a mobile phase A and a mobile phase B, wherein the mobile phase A contains a phosphate buffer solution; themobile phase B contains acetonitrile; the gradient elution is carried out on the sample solution of the fosaprepitant dimeglumine raw material or preparation within 0 to 50min by the mobile phase A and the mobile phase B. The detection methods are simple and convenient to operate, easy to control and low in detection cost, and can be used for effectively monitoring the impurity in a fosaprepitantdimeglumine drug and accurately measuring the content of the impurity.

Description

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Claims

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Application Information

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Owner CHENGDU BAIYU PHARMA CO LTD
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