The invention discloses a quantitative
analysis method and device for stable
isotope labeled recombinant
human growth hormone, and belongs to the technical field of quantitative analysis of
protein, the method comprises the following steps: S1, preliminarily measuring the purity of stable
isotope labeled recombinant
human growth hormone based on
chromatography or
electrophoresis; s2, on the basis of preliminarily determining the purity of the stable
isotope labeled recombinant
human growth hormone in the step S1, measuring the stable isotope labeled
amino acid replacement efficiency through
amino acid analysis-
isotope dilution mass spectrometry; and S3, based on the stable isotope labeled
amino acid replacement efficiency, measuring the content of the stable isotope labeled recombinant human
growth hormone through
peptide fragment quantitative analysis-
isotope dilution mass spectrometry. According to the method, the
isotope dilution mass spectrometry is adopted to eliminate
system errors possibly introduced in the pretreatment step and the measurement process, and the accuracy and credibility of the measurement result can be remarkably improved. According to the method, traceable quantitative analysis of the content of the stable isotope labeled recombinant human
growth hormone can be realized, and the measurement result can be traced to the international
system of units.