A method for detecting ethylene glycol and diethylene glycol in an aripiprazole oral solution

By employing high-performance gas chromatography and gradient temperature elution technology, the problem of separating and detecting ethylene glycol and diethylene glycol in aripiprazole oral solution was solved, achieving high-precision control of drug quality and ensuring the safety and stability of the drug.

CN122361668APending Publication Date: 2026-07-10
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Patent Information

Application Number
CN202610657283.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Filing Date
2026-05-13
Publication Date
2026-07-10

AI Technical Summary

Technical Problem

Existing methods for detecting ethylene glycol and diethylene glycol in aripiprazole oral solution suffer from interference from blank excipient peaks, making it difficult to achieve high-precision separation and detection, thus affecting drug quality control.

Method used

High-performance gas chromatography (HPLC) was used to analyze ethylene glycol and diethylene glycol in aripiprazole oral solution using a 100% bonded cross-linked polyethylene glycol (PEG) capillary column, a flame ionization detector, and nitrogen carrier gas, combined with gradient temperature elution.

Benefits of technology

This method enables the effective separation and accurate quantitative detection of ethylene glycol and diethylene glycol in aripiprazole oral solution, reducing side reactions, eliminating excipient interference, and ensuring the safety and stability of the drug.

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Abstract

Invention Title: A Method for Detecting Ethylene Glycol and Diethylene Glycol in Aripiprazole Oral Solution Abstract: This invention provides a method for detecting ethylene glycol and diethylene glycol in aripiprazole oral solution, applicable to the field of drug oral preparation detection technology, especially in the field of pharmaceutical quality control, requiring gas chromatography detection methods to monitor pharmaceutical excipients and byproducts. This analytical method overcomes the limitations of ethylene glycol and diethylene glycol, which lack ultraviolet absorption methods. The sample solution is injected into the injection port via a microsyringe, and instantly vaporized in a high-temperature vaporization chamber, increasing sensitivity and accuracy, and solving the problems of low detection efficiency and low precision. Separation and detection efficiency are improved by optimizing column temperature and other conditions. This invention uses high-performance gas chromatography (HPLC) with a 100% bonded cross-linked polyethylene glycol (PEG) capillary column, a flame ionization detector, nitrogen as the carrier gas, and an organic solvent as the diluent. It uses a conventional chromatographic column, an automated injection method, and reduces costs. Gradient temperature elution is employed for separation and detection. This invention relates to a method for the detection of ethylene glycol and diethylene glycol in aripiprazole oral solution. This method has good separation, high specificity, high precision, and good repeatability, and meets the requirements for methodological research on the determination of ethylene glycol and diethylene glycol in aripiprazole oral solution.
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