A kind of detection method of degradation impurity aldol dimer content in oxycodone liquid preparation

Abstract

The invention provides a method for detecting the content of degraded impurity aldol dimers in oxycodone liquid preparations, and belongs to the technical field of drug analysis. The present invention adopts high-performance liquid chromatography for detection. By precisely controlling the detection conditions, octadecylsilane-bonded silica gel is selected as the chromatographic column of the filler, and the composition and ratio of the mobile phase are controlled. At the same time, a gradient elution method is adopted to control the gradient The elution procedure can detect the content of impurity dimers produced by degradation in oxycodone hydrochloride liquid preparations. The detection method has high sensitivity and strong specificity, and can ensure that the genotoxic impurity dimers in oxycodone hydrochloride liquid preparations are effective. Detection provides a strong control strategy for the product quality control of this type of drug, thus providing a guarantee for product quality, safety and effectiveness. Moreover, the detection method of the present invention is accurate, stable, durable, scientific and reliable, and can better measure the content of oxycodone aldol dimer in the oxycodone liquid preparation.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for detecting the content of degraded impurity aldol dimers in oxycodone liquid preparations. Background technique [0002] The main active ingredient in oxycodone hydrochloride liquid preparations is oxycodone hydrochloride. The chemical name of oxycodone is 7,8-dihydro-14-hydroxycodeinone, and the molecular formula is: C 18 h 21 NO 4 , molecular weight: 315.37, structural formula: [0003] [0004] Oxycodone was first produced in Germany in 1916 from thebaine as a generic drug. In 2017, it was the 52nd most prescribed drug in the United States, with more than 15 million prescriptions filled. There are now some abuse-deterrent formulations, such as in combination with naloxone, an opioid used to treat moderate to severe pain, and a common anesthesia on the market for intraoperative or cancer pain Pain medication. It is usually taken orally, and the onset ...

AI Technical Summary

Problems solved by technology

[0007] According to the Q3A requirements of the International Council for Harmonization for Human Use (ICH) and the general requirements of the State Drug Administration for the declaration of safe, effective and quality-controllable drugs, and according to the relevant guidelines for drug quality research, the relevant impurities of drugs should be effectively tested. control to ensure that the product quality is controllable, but the above-mentioned polar compounds with large molecular weight of the degraded impurity aldol dimer are not suitable for detection by ordinary isocratic elution methods, because it is extremely difficult to combine with the main component oxycodone Separation, or it is very easy to cause severe peak tailing after separation, which will affect the sensitivity of the detection sample

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