Method for detecting concentration of related substances in ibuprofen medicine based on ultrahigh liquid chromatography

Abstract

The invention discloses a method for detecting the concentration of related substances in an ibuprofen drug based on ultrahigh liquid chromatography, and belongs to the technical field of analytical chemistry. According to the detection method, the related substances in the ibuprofen medicine are determined on the basis of high performance liquid chromatography; and the related substances such asimpurities C, impurities J, impurities M and impurities ibuprofen sorbitol ester in the ibuprofen medicine are qualitatively and quantitatively detected by adopting the ultra-high performance liquid chromatography, so that the analysis time of a sample can be shortened to 1 / 3 of that of an HPLC analysis method; impurities with different structures are separated and detected in a short time; the UPLC is provided with a low-diffusion and low-cross-contamination automatic sample injector, and is provided with an in-needle sample injection probe and a pressure-assisted sample injection technology,so that the detection method designed by the invention is more excellent in repeatability and stability, and can effectively detect impurities.

Description

[0001] The invention relates to the detection of impurities in medicine, and belongs to the technical field of analytical chemistry, in particular to a method for detecting the concentration of related substances in ibuprofen medicine based on ultra-high liquid chromatography. Background technique [0002] Ibuprofen is an antipyretic and analgesic, non-steroidal anti-inflammatory drug. It inhibits cyclooxygenase, reduces the synthesis of prostaglandins, and produces analgesic and anti-inflammatory effects; it acts as an antipyretic through the hypothalamic thermoregulatory center. Ibuprofen medicines, such as soft capsules, include a rubber skin and the ibuprofen-containing content wrapped in the rubber skin, which has the advantages of good stability, convenient administration and high bioavailability, and is currently a widely used dosage form in clinical practice. [0003] Related substances are process impurities introduced in the production process of the drug or degradat...

AI Technical Summary

Problems solved by technology

[0004] High Performance Liquid Chromatography (HPLC) is a common means of determining related substances in ibuprofen medicines. The accuracy and stability of its separation technology are good, and almost all organic impurities can be separated and detected better; but due to impurities More, HPLC determines the analysis time of related substances in ibuprofen medicine is longer, and the running time of a needle sample is 90min, and the time cost and solvent cost of detection are higher; at the same time, due to the longer analysis time, for high performance liquid chromatography and The durability of the chromatographic column has higher requirements

In addition, when using HPLC to determine related substances in ibuprofen, the relative retention time of impurity M and ibuprofen sorbitol ester is relatively close, and the degree of separation is low. , due to the influence of the drift of the retention time of each peak, it is easy to cause the confusion of the positioning of the impurity M and the ibuprofen sorbitol ester, which affects the accurate quantification of the impurity M and the ibuprofen sorbitol ester in the ibuprofen drug

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