Method capable of detecting 3, 5 - di-tert-butyl - 4 - hydroxyphenylpropionic acid and 2, 4 - di-tert-butylphenol in sodium chloride injection solution

Abstract

The present invention discloses a method capable of detecting 3, 5 - di-tert-butyl - 4 - hydroxyphenylpropionic acid and 2, 4 - di-tert-butylphenol in a compound sodium chloride injection solution, pertaining to the field of pharmaceutical packaging antioxidant migration. A liquid chromatography method is adopted to perform detection. According to the method, the contents of the 3, 5 - di-tert-butyl - 4 - hydroxyphenylpropionic acid and the 2, 4 - di-tert-butylphenol in the compound sodium chloride injection solution are investigated via a liquid chromatograph, direct filtration injection is adopted in pre-processing, and the process is simple and easy to operate. The method has excellent performance in specificity, precision, accuracy, linearity, limit of detection and limit of quantification, and thus the method can be taken as a general method capable of detecting the contents of the 3, 5 - di-tert-butyl - 4 - hydroxyphenylpropionic acid and the 2, 4 - di-tert-butylphenol in the compound sodium chloride injection solution or similar property substrates.

Description

technical field [0001] The invention relates to the field of migration of antioxidants in pharmaceutical packaging, in particular to a method for stably detecting 3,5-di-tert-butyl-4-hydroxyphenylpropionic acid and 2,4-di-tert-butylphenol in compound sodium chloride injection Methods. Background technique [0002] Drug packaging materials play a vital role in ensuring the stability of drugs, and are closely related to drug safety. Improper selection of packaging materials for medicines will lead to migration, adsorption and even chemical reactions of the active ingredients of the medicines, making the medicines ineffective, and some will produce serious toxic and side effects. [0003] Tris(2,4-di-tert-butylphenyl)phosphite (hereinafter referred to as Antioxidant 168) is one of the most widely used antioxidants in the field of plastic infusions, and is generally used in combination with main antioxidants 1010 and 1076 , has an excellent synergistic effect, can effectively ...

AI Technical Summary

Problems solved by technology

[0004] The plastic infusion package is in direct contact with the infusion medicine. During the long-term contact process, the additives in the material may be released into the medicine. Through long-term inspection and observation, the antioxidants 1010, 1076, and 168 are basically not detected in the medicine preparation. This is not the case. It is difficult for several substances to migrate, but because the large infusion solution uses water as the matrix, and these substances are not soluble in water, so it is difficult to detect

The study found that the degradation product of antioxidant 1010 and antioxidant 1076, 3,5-di-tert-butyl-4-hydroxyphenylpropionic acid, and the degradation product of antioxidant 168, 2,4-di-tert-butylphenol, were gradually released In the liquid medicine, these two substances are not the additives themselves, but the degradation products of the additives, so there is no standard method to specify the content detection method at present.

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