Quantitative assay method of PEG-modified medicine in biological sample

• Main Authors: SU CHONG, YIN LEI, YANG YAN, JING XIABIN, PENG WENWEN, GU JINGKAI, LU HUAN, MENG XIANGJUN, LIN WENHAI, SHI MEIYUN
• Format: Patent
• Language: English
• Published: 21.10.2015
• Subjects: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; PHYSICS; TESTING

The invention provides a quantitative assay method of PEG-modified medicine in a biological sample. Assay is conducted through liquid chromatogram-flight time mass spectrum. The method includes the steps that firstly, a standard curve is made; secondly, sample introduction assay is conducted on the sample to be tested, and the concentrate of the PEG-modified medicine and free medicine in the sample to be tested are worked out. The mass spectrum condition is based on a triple tandem mass spectrum technology, and the mass spectrum is set in the mode that parent ions are not selected in a first mass analyzer Q1, and charge particles enter a second mass analyzer Q2 after passing through the first mass analyzer Q1 totally; energy collision is set in the second mass analyzer Q2, and the charge particles are smashed into fragment ions; stable PEG-modified medicine feature fragment ions and free medicine feature fragment ions are selected in a third quality analyzer ion trap or flight time mass analyzer to quantitate the PEG-modified medicine and the free medicine. According to the method, for the nonuniqueness of PEG-modified medicine molecular weight in the biological sample, the quantitative assay method is established, and analysis and quantitation can be conducted on the PEG-modified medicine and the free medicine in the biological sample at the same time.