Method for detecting related substances of N-methyl-N '-tetrahydrofuranformyl propane diamine oxalate

Abstract

The invention discloses a method for detecting related substances of N-methyl-N '-tetrahydrofuranformyl propane diamine oxalate, liquid chromatography is adopted for detection, a chromatographic column is Waters XSelect HSS T3 with the size of 150mm * 4.6 mm and 3.5 mu m or YMC Triart C18 with the size of 150mm * 4.6 mm and 3.0 mu m, and a mobile phase A is a trifluoroacetic acid dilute solution; the mobile phase B is an acetonitrile solution containing trifluoroacetic acid. When the chromatographic column and the mobile phase are used for determination, a solvent peak, an impurity peak and a product main peak can be well separated, and when an ultraviolet detector is used for detection, solvent interference can be effectively avoided, so that the impurity content can be accurately detected.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a method for detecting a related substance of N-methyl-N'-tetrahydrofuroyl propanediamine oxalate. Background technique [0002] The statements herein merely provide background related to the present invention and do not necessarily constitute prior art. [0003] N-methyl-N'-tetrahydrofuroylpropanediamine is an important synthetic raw material, and the raw material is an oily substance, which contains a large amount of organic solvent, and has relatively poor stability, which is inconvenient for long-term storage. In general industrial production, it is basically used and prepared. Therefore, the inventors processed it into a salt, and the oxalate of this substance was proved to be industrially applicable. Since the purity directly affects the quality of the final product, the related substances need to be tested. [0004] The information of N-methyl-N'-tetrahydro...

AI Technical Summary

Problems solved by technology

Therefore, the use of an evaporative light detector to check the related substances of this product was first considered. The results showed that the response value of the evaporative light detector was too low and the detection limit was too high to detect the impurities of this product.

Consider using gas chromatography for detection, the detection result is greatly affected by the vaporization temperature, and it is difficult to use gas chromatography detection method for effective detection

Therefore, an ultraviolet detector is selected to check the related substances of this product. Since this product is a small molecular compound, there is only terminal absorption (the maximum absorption is around 200nm), and there is a large solvent interference, which greatly affects the accuracy of detection.

Images