Method for detecting content of impurity aldol dimer through degradation in oxycodone liquid preparation

Abstract

The invention provides a method for detecting the content of impurity aldol dimer through degradation in an oxycodone liquid preparation, and belongs to the technical field of pharmaceutical analysis. According to the method, high performance liquid chromatography is adopted for detection, detection conditions are accurately controlled, octadecylsilane chemically bonded silica is selected as a chromatographic column of a filling agent, the composition and proportion of a mobile phase are controlled, a gradient elution method is adopted, a gradient elution procedure is controlled, and the content of the impurity dimer generated by degradation in the oxycodone hydrochloride liquid preparation can be detected. The detection method is high in sensitivity and specificity, it can be ensured that the genotoxic impurity dimer in the oxycodone hydrochloride liquid preparation is effectively detected, a powerful control strategy is provided for product quality control of the medicine, and a guarantee is effectively provided for product quality and safety. Moreover, the detection method disclosed by the invention is accurate, stable, durable, scientific and reliable, and the content of oxycodone aldol dimer in the oxycodone liquid preparation can be well measured.

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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