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A method for detecting related substances in remifentanil hydrochloride bulk drug

A technology of related substances and detection methods, which is applied in the field of detection of related substances in remifentanil hydrochloride raw materials, and can solve problems such as unclear impurity components and content, inability to clearly display specific content, clinical application impact, etc.

Active Publication Date: 2015-10-07
YICHANG HUMANWELL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the existence of certain impurities in the finished product, it has a certain impact on its clinical application
At the same time, since the detection method of related substances in remifentanil hydrochloride bulk drug is not included in the Chinese Pharmacopoeia, it is a standard promulgated by the State Food and Drug Administration in 2009, WS1-(X-008)-2009Z (also Drafted by our company), its detection sensitivity is poor, it cannot achieve a good baseline separation from impurities, the composition and content of impurities are not clear, and the specific content of each related substance cannot be clearly displayed. Benzyl compounds, acetylated compounds, etc.

Method used

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  • A method for detecting related substances in remifentanil hydrochloride bulk drug
  • A method for detecting related substances in remifentanil hydrochloride bulk drug
  • A method for detecting related substances in remifentanil hydrochloride bulk drug

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059]Take 120801 batches of remifentanil hydrochloride raw material about 0.1g, add methanol 10ml to dissolve, as the test solution, inject 10μl, the chromatographic conditions refer to a standard promulgated by the State Food and Drug Administration in 2009, the chromatographic column is ten An octaalkylsilane bonded silica gel (3um) chromatographic column, 0.1m×4.6mm, with a detection wavelength of 220nm, to obtain a chromatogram.

Embodiment 2

[0061] Take 120802 batches of remifentanil hydrochloride raw material about 0.1g, add methanol 10ml to dissolve, as the test solution, inject 10μl, the chromatographic conditions refer to a standard promulgated by the State Food and Drug Administration in 2009, the chromatographic column is ten An octaalkylsilane bonded silica gel (3um) chromatographic column, 0.1m×4.6mm, with a detection wavelength of 220nm, to obtain a chromatogram.

Embodiment 3

[0063] Take 121101 batches of remifentanil hydrochloride raw material about 0.1g, add methanol 10ml to dissolve, as the test solution, inject 10μl, the chromatographic conditions refer to a standard promulgated by the State Food and Drug Administration in 2009, the chromatographic column is ten An octaalkylsilane bonded silica gel (3um) chromatographic column, 0.1m×4.6mm, with a detection wavelength of 220nm, to obtain a chromatogram.

[0064] From the chromatogram Figure 1-9 , using the detection method of the present invention, each impurity can be separated quickly, and the specific type and content of each impurity can be determined, while referring to the drug standard promulgated by the State Food and Drug Administration in 2009 Figure 10-12 It can be seen that all related substances have not been detected, and the baseline separation is not good, so the detection method of the present invention is of great significance for improving the purity of remifentanil hydrochl...

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PUM

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Abstract

The invention provides a relevant substance detection method which is high in sensitivity and short in detection time. Through the adoption the method, the content of relevant substances can be rapidly and accurately detected, and the separation degree between impurity peak and main peak is greater than or equal to 1.5. The method specifically comprises the steps of confirming the relevant substances and confirming the chromatographic condition, wherein the chromatographic condition is that the octadecyl silane bonded silica gel (3mu m) chromatographic column is 0.1m*4.6mm, the concentration of a mobile phase A sal volatile solution is 5g / l, tetrahydrofuran-water (10:90) is used as a solvent, and acetonitrile is used as a mobile phase B.

Description

Background technique [0001] Remifentanil (1-piperidinepropionic acid, 4-(methoxy-carbonyl)-4-((1-oxopropyl)phenylamino)-, methyl ester; CAS No. 132875-61- 7) is a synthetic opioid. which has the formula C 20 h 28 N 2 o 5 , and has the following structural formula: [0002] [0003] The most common salt of remifentanil is remifentanil hydrochloride (CAS No. 132539-07-2) [0004] [0005] N-Phenyl-N-(4-piperidinyl)amides, such as remifentanil, and their preparation were originally described in US Patent 5,019,583, the contents of which are incorporated herein by reference in their entirety. US Patent 5,466,700, the contents of which are hereby incorporated by reference in their entirety, describes the use of opioids described in US Patent 5,019,583 to induce and maintain anesthesia and conscious sedation. [0006] Remifentanil is a commercially available injection or infusion, and the trade name is (GlaxoSmithKline), which has broad market prospects. Due to the p...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/88
Inventor 陈鹏汪汶朱卫国赵蔓菁田军付蓉钟丽君郑炜晏涛
Owner YICHANG HUMANWELL PHARMA