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.