abstract |
The present invention disclosed a test method of ibuprofen injection related substances that include arginine, which uses high -efficiency liquid chromatography to detect it. It is qualitative or quantified to the relevant substances. The detection conditions include, the detector: ELSD detector; color spectrum column: alkyl -alkyne bonding silicone column or amino column; flow phase: including organic phase, water phase, the volume ratio of organic phase and water phase is 50 ~ 70: 50 ~ 30, preferably 65:35 The method of the present invention can accurately monitor arginine -related substances, thereby providing guarantee for the quality and safety of ibuprofen injection. |