Method for detecting related substances of polysorbate 80

Abstract

The invention discloses a method for detecting related substances of polysorbate 80. The method comprises the following steps of: (a) preparation of the solution of a reference substance; (b) the preparation of the solution of a test sample; (c) chromatographic condition and system applicability test; (d) determination method, namely precisely measuring 20 microliters of the solution of the reference substance and 20 microliters of the solution of the test sample respectively by adopting high performance liquid chromatography in the 2005 version of Chinese pharmacopoeia 2005 second part appendix VD; injecting the solution into a liquid chromatograph; and recording a chromatogram map; and (e) result judgment, namely nonassimilation is at a retention time of the chromatographic peak of vitamin D2. The method improves the quality control standard of medicinal accessories of the polysorbate 80, so that the interference of the related substances on the determination of the content of main medicament components and potential adverse reactions possibly caused by the related substances can be effectively avoided.

Description

technical field [0001] The invention relates to a quality control method of pharmaceutical auxiliary materials, in particular to a method for detecting related substances of the auxiliary material polysorbate 80 used in the fat-soluble vitamin (II) for injection. Background technique [0002] The main ingredients contained in the fat-soluble vitamin (II) for injection are vitamin A and vitamin D 2 , vitamin E and vitamin K 1 . Since the raw materials of these main drugs have low polarity and are difficult to dissolve in water, it is usually necessary to add polysorbate 80 for solubilization during drug preparation. Polysorbate 80 is polyoxyethylene 20 sorbitan monooleate, which is a complex mixture. At present, when it is used as a pharmaceutical excipient, its relative density is usually determined according to the "Chinese Pharmacopoeia" (2005 Edition, Part II - Page 918). , Viscosity, acid value, saponification value, hydroxyl value, iodine value, pH and other items ar...

AI Technical Summary

Problems solved by technology

For example, when the applicant prepared fat-soluble vitamin (II) for injection with polysorbate 80 produced by Liaoyang Aoke Nano Material Co., Ltd. The determination of the content of fat-soluble vitamin (II) for injection prepared by polysorbate 80 with batch number F080708120 is qualified, while the content of fat-soluble vitamin (II) for injection prepared by polysorbate 80 with batch number of F081217137 is qualified. Failed, specifically vitamin D 2 The content of can not be calculated due to unqualified resolution

However, there is no relevant report on the detection method of related substances of polysorbate 80

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