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The LC\u2013MS\/MS method saved costs, decreased the analysis time, and reduced quantitative times relative to the traditional ligand\u2010binding assays. The serum samples were digested with trypsin at 50\u00b0C for 60\u2009min after methanol precipitation, ammonium bicarbonate denaturation, dithiothreitol reduction, and iodoacetamide alkylation. The tryptic peptides were chromatographically separated using a C18 column (2.1\u2009\u00d7\u200950\u2009mm, 2.6\u2009\u03bcm) with mobile phases of 0.1% formic acid in water and acetonitrile. The other monoclonal antibody, infliximab, was used as internal standards to minimize the variability during sample processing and detection. A unique peptide for each monoclonal antibody was simultaneously quantified using LC\u2013MS\/MS in the multiple reaction monitoring mode. Calibration curves were linear from 2.0 to 400\u2009\u03bcg\/mL. The intra\u2010 and inter\u2010assay precision (%CV) was within 8.9 and 7.4% (except 10.4 and 15.1% for lower limit of quantitation), respectively, and the accuracy (%Dev) was within \u00b113.1%. The other validation parameters were evaluated, and all results met the acceptance criteria of the international guiding principles. Finally, the method was successfully applied to a pharmacokinetics study after a single\u2010dose intravenous drip administration to cynomolgus monkeys.<\/jats:p>","DOI":"10.1002\/bmc.4903","type":"journal-article","created":{"date-parts":[[2020,5,19]],"date-time":"2020-05-19T17:55:19Z","timestamp":1589910919000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Method development and validation of LC\u2013MS\/MS\u2010based assay for the simultaneous quantitation of trastuzumab and pertuzumab in cynomolgus monkey serum and its application in pharmacokinetic study"],"prefix":"10.1002","volume":"34","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3698-3235","authenticated-orcid":false,"given":"Luo\u2010lan","family":"Gui","sequence":"first","affiliation":[{"name":"School of Chemical Engineering Tianjin University  Tianjin China"},{"name":"State Key Laboratory of Proteomics, Beijing Proteome Research Center, National Center for Protein Sciences (Beijing) Beijing Institute of Lifeomics  Beijing China"},{"name":"Beijing United\u2010Power Pharma Tech Co., Ltd.  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Li","family":"Li","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Proteomics, Beijing Proteome Research Center, National Center for Protein Sciences (Beijing) Beijing Institute of Lifeomics  Beijing China"},{"name":"Beijing United\u2010Power Pharma Tech Co., Ltd.  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Li\u2010hou","family":"Dong","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Proteomics, Beijing Proteome Research Center, National Center for Protein Sciences (Beijing) Beijing Institute of Lifeomics  Beijing China"},{"name":"Beijing United\u2010Power Pharma Tech Co., Ltd.  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shen\u2010si","family":"Xiang","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Proteomics, Beijing Proteome Research Center, National Center for Protein Sciences (Beijing) Beijing Institute of Lifeomics  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jian\u2010ping","family":"Zhai","sequence":"additional","affiliation":[{"name":"School of Chemical Engineering Tianjin University  Tianjin China"},{"name":"State Key Laboratory of Proteomics, Beijing Proteome Research Center, National Center for Protein Sciences (Beijing) Beijing Institute of Lifeomics  Beijing China"},{"name":"Beijing United\u2010Power Pharma Tech Co., Ltd.  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