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This is crucial to manage potential toxicities linked to drug concentrations and supervise dosing regimens. A cutting\u2010edge ultra\u2010high performance liquid chromatography\u2013tandem mass spectrometry bioassay for risdiplam in human serum has been developed. In this method, analytes were separated on a Phenomenex Kinetex XB C<jats:sub>18<\/jats:sub> column using a 6.5\u2010min gradient elution after a single\u2010step protein precipitation. MS detection was conducted via electrospray ionization in positive mode with selected reaction monitoring. The validated range for risdiplam was determined to be 1.95\u2013125.00 ng\/mL. The precision and accuracy of intra\u2010 and inter\u2010batch analyses were within \u00b115%. The novel method met all other established criteria. This assay holds promise for monitoring drug concentrations and guiding clinical decisions in patients with spinal muscular atrophy.<\/jats:p>","DOI":"10.1002\/bmc.5934","type":"journal-article","created":{"date-parts":[[2024,7,16]],"date-time":"2024-07-16T00:55:00Z","timestamp":1721091300000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Analysis of blood concentrations and clinical application of risdiplam in patients with spinal muscular atrophy using ultra\u2010high performance liquid chromatography\u2013tandem mass spectrometry"],"prefix":"10.1002","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0009-0000-8506-4262","authenticated-orcid":false,"given":"Xian","family":"Wu","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacy Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine  Shanghai China"},{"name":"Department of Pharmacy Chongqing Medical University  Chongqing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhiyan","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xinzhu","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhenghong","family":"Yi","sequence":"additional","affiliation":[{"name":"Department of Pharmacy 363 Hospital  Sichuan Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaohui","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jian","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine  Shanghai China"},{"name":"Department of Pharmacy Chongqing Medical University  Chongqing China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,7,15]]},"reference":[{"key":"e_1_2_9_2_1","volume-title":"Guidelines for validation of methods for quantitative analysis of biological samples","author":"Chinese Pharmacopoeia Commission","year":"2020"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-020-01410-z"},{"key":"e_1_2_9_4_1","volume-title":"Drug description of risdiplam powder for oral solution","author":"F. 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