Bioanalysis最新文献_第3页

A validated UHPLC-MS/MS method for determination of BPI-43487 and its metabolite BPI-43739 in human plasma and its application to a pharmacokinetic study in Chinese patients with advanced solid tumors. UHPLC-MS/MS法测定人血浆中BPI-43487及其代谢物BPI-43739及其在中国晚期实体瘤患者药代动力学研究中的应用

IF 1.8 4区医学

Bioanalysis Pub Date : 2026-01-01 Epub Date: 2026-02-10 DOI: 10.1080/17576180.2026.2628084

Yunhai Bo, Jing Lu, Min Jiang, Xiaohong Liu, Le Le, Xiaoyun Liu, Hong Lan, Jifang Gong, Fen Yang

{"title":"A validated UHPLC-MS/MS method for determination of BPI-43487 and its metabolite BPI-43739 in human plasma and its application to a pharmacokinetic study in Chinese patients with advanced solid tumors.","authors":"Yunhai Bo, Jing Lu, Min Jiang, Xiaohong Liu, Le Le, Xiaoyun Liu, Hong Lan, Jifang Gong, Fen Yang","doi":"10.1080/17576180.2026.2628084","DOIUrl":"10.1080/17576180.2026.2628084","url":null,"abstract":"Background: BPI-43487 is a novel irreversible fibroblast growth factor receptor 4 inhibitor.Research design and methods: A simple and reliable liquid chromatography-tandem mass spectrometry method was developed and validated for simultaneous determination of BPI-43487 and its active metabolite BPI-43739 in human plasma. BPI-43487B was used as the internal standards (IS). Plasma samples were protein precipitated by acetonitrile and processed samples were chromatographed on an AQUITY UHPLC BEH C18 column (50 × 2.1 mm, i.d. 1.7 μm) with acetonitrile and 10 mM ammonium acetate containing 0.1% formic acid (v/v) as the mobile phase.Results: Calibration curves demonstrated good linearity (R ≥0.99) over the concentration range of 10.0-5000 ng/mL for both analytes. Intra- and inter-batch precisions were ≤9.2% for BPI-43487 and ≤8.7% for BPI-43739. The accuracies were 94.6-104.8% for BPI-43487 and 95.0-108.4% for BPI-43739.Conclusions: This method was further successfully applied to a pharmacokinetic study of BPI-43487 capsules in Chinese patients with advanced solid tumors.China drug trials: http://www.chinadrugtrials.org.cn is CTR20210565).","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"69-76"},"PeriodicalIF":1.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12998019/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146148973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Mitigation of pre-existing immunogenicity in ADA method development. 缓解ADA方法开发中预先存在的免疫原性。

IF 1.8 4区医学

Bioanalysis Pub Date : 2026-01-01 Epub Date: 2026-02-03 DOI: 10.1080/17576180.2026.2623034

Jihua Chen, Henry Zhao, Chris Gardner, Jianquan Wang, Meng Chen, Ming Li, Praveen Amancha, Manoj Rajadhyaksha, Ryan Pelto

{"title":"Mitigation of pre-existing immunogenicity in ADA method development.","authors":"Jihua Chen, Henry Zhao, Chris Gardner, Jianquan Wang, Meng Chen, Ming Li, Praveen Amancha, Manoj Rajadhyaksha, Ryan Pelto","doi":"10.1080/17576180.2026.2623034","DOIUrl":"10.1080/17576180.2026.2623034","url":null,"abstract":"Background: Immunogenicity assessments are critical for evaluating biological therapeutics. Preexisting immune reactivity can affect clinical safety and efficacy and confound anti-drug antibody (ADA) assay cut point determination, complicating identification of treatment-emergent ADA. In the ALXN-X program, approximately 50% of naïve human serum samples showed preexisting reactivity, with some signals exceeding background by more than 100-fold, challenging ADA method development (cut points, sensitivity, drug tolerance).Methods: Competitive inhibition experiments were conducted to map the binding site of the preexisting reactivity and depletion with protein A/G agarose was performed to further characterize the preexisting reactivity. A modified ADA assay with an engineered drug molecule was developed to mitigate its impact on assay performance.Results: This preexisting reactivity binds to the C-terminal conserved framework sequence of the drug molecule. Characterization indicated that the preexisting reactivity is likely attributable to immunoglobulins. The modified ADA assay can effectively mitigate the impact of the preexisting reactivity on the assay performance, while maintaining the ability to detect ADA response specific to the unique epitopes of ALXN-X.Conclusions: Preexisting, immunoglobulin-mediated reactivity targeting ALXN-X's Cterminal framework sequence complicates ADA assay performance. A modified ADA assay mitigates this interference while preserving detection of ALXN-X-specific ADA, supporting more reliable immunogenicity assessment.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"35-43"},"PeriodicalIF":1.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12997999/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146103562","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Balancing performance and sustainability: a white differential pulse voltammetry method for metformin and empagliflozin in plasma. 平衡性能和可持续性：血浆中二甲双胍和依格列净的白差分脉冲伏安法。

IF 1.8 4区医学

Bioanalysis Pub Date : 2026-01-01 Epub Date: 2026-02-20 DOI: 10.1080/17576180.2026.2630071

Osama I Abdel Sattar, Hamed H M Abuseada, Mohamed S Emara, Islam Selim, Nahla A Abdelshafi

{"title":"Balancing performance and sustainability: a white differential pulse voltammetry method for metformin and empagliflozin in plasma.","authors":"Osama I Abdel Sattar, Hamed H M Abuseada, Mohamed S Emara, Islam Selim, Nahla A Abdelshafi","doi":"10.1080/17576180.2026.2630071","DOIUrl":"10.1080/17576180.2026.2630071","url":null,"abstract":"Background: Simultaneous therapeutic drug monitoring of metformin (MEF) and empagliflozin (EMP) in plasma requires sustainable, white analytical chemistry (WAC) methods. Existing techniques suffer from poor greenness, electrode modification complexity, and limited plasma applicability.Research design and methods: White/green differential pulse voltammetry (DPV) method developed using unmodified glassy carbon electrode (GCE). Protein precipitation (acetonitrile) from ethically sourced blank human plasma (BUC-IACUCPHA183A/2025). Optimized: phosphate buffer pH 7, 75 mV/s scan rate. Validated per ICH Q2(R1) across linearity, LOD/LOQ, accuracy, precision, specificity (n = 9).Results: Linearity: MEF 20-60 μM (r = 0.997), EMP 10-70 μM (r = 0.997). LODs: 4.38 μM (MEF), 4.15 μM (EMP). Plasma recoveries: 99.4 ± 1.5% (MEF), 100.4 ± 1.4% (EMP), n = 5. Whiteness: 97/100 (RGB-12); greenness: 83/100 (MOGABI) - superior to reported methods.Conclusions: Validated DPV-GCE enables rapid, sustainable MEF/EMP quantification in plasma without modification/chromatography. Proof-of-concept for routine therapeutic monitoring; clinical translation limited by spiked (not patient) samples.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"111-120"},"PeriodicalIF":1.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12998007/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146257049","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Determination of R/S-enantiomers of methamphetamine and amphetamine in human hair with chiral stationary phase LC-MS/MS. 手性固定相LC-MS/MS测定人头发中甲基苯丙胺和安非他明的R/ s对映体。

IF 1.8 4区医学

Bioanalysis Pub Date : 2026-01-01 Epub Date: 2026-01-30 DOI: 10.1080/17576180.2026.2623033

Yunfeng Zhang, Yong Liu, Chao Yuan, Weiwei Zhuge, Bo Zou, Linpei Dong, Xiaojun Wu, Zheng Ouyang, Manman Zhang, Haixing Wang

{"title":"Determination of R/S-enantiomers of methamphetamine and amphetamine in human hair with chiral stationary phase LC-MS/MS.","authors":"Yunfeng Zhang, Yong Liu, Chao Yuan, Weiwei Zhuge, Bo Zou, Linpei Dong, Xiaojun Wu, Zheng Ouyang, Manman Zhang, Haixing Wang","doi":"10.1080/17576180.2026.2623033","DOIUrl":"10.1080/17576180.2026.2623033","url":null,"abstract":"Background: As the synthetic abused drug with high addictive potential, methamphetamine (METH) and its major metabolite amphetamine (AMP) are chiral compounds. The S-enantiomer of METH is primarily abused because of its potent psychoactive effects, whereas the R-enantiomer may originate from the metabolism of selegiline, a prescription medication for Parkinson's disease.Research design and methods: This research aimed to develop a robust and reliable analytical method to distinguish illicit METH abuse from legal selegiline therapy. A novel, simplified chiral stationary phase liquid chromatography-tandem mass spectrometry (CSP-LC-MS/MS) method was developed and validated for the rapid determination of R- and S-enantiomers of METH and AMP in human hair, eliminating the need for derivatization pretreatment.Results: Employing an Agilent Chiral-V column under isocratic conditions, the developed CSP-LC-MS/MS method achieved efficient baseline separation (resolution ≥2) and rapid quantification of the R/S enantiomers of METH and AMP within 10 min. Analysis of hair samples from three METH abusers revealed a predominance of the S-enantiomers. Conversely, only the R-enantiomer was detected in the hair of a selegiline user.Conclusions: This research enables precise enantiomer differentiation, offering critical insights into drug metabolism and forensic discrimination between illicit METH abuse and legitimate selegiline treatment.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"17-26"},"PeriodicalIF":1.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12997962/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146083501","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A new sensitive derivatization assay of PrC-210 in plasma and tissues using liquid chromatography coupled with tandem mass spectrometry. 液相色谱-串联质谱联用分析血浆和组织中PrC-210的新方法。

IF 1.8 4区医学

Bioanalysis Pub Date : 2026-01-01 Epub Date: 2026-02-12 DOI: 10.1080/17576180.2026.2623031

Bryan L Fahl, Cameron O Scarlett, William E Fahl

{"title":"A new sensitive derivatization assay of PrC-210 in plasma and tissues using liquid chromatography coupled with tandem mass spectrometry.","authors":"Bryan L Fahl, Cameron O Scarlett, William E Fahl","doi":"10.1080/17576180.2026.2623031","DOIUrl":"10.1080/17576180.2026.2623031","url":null,"abstract":"Background: PrC-210 is a direct-acting reactive oxygen species (ROS) scavenger. It is active when administered orally, IV, or subcutaneously. Its profound efficacy in preclinical models makes it a candidate to prevent human ROS-induced i) ionizing radiation toxicities, ii) neurodegenerative disease, and iii) organ ischemia-reperfusion injuries.Research design and methods: A simple, highly sensitive, specific LC-MS/MS method was developed to measure the PrC-210 molecule in mouse plasma and tissue homogenates. To prevent oxidative degradation or disulfide formation of the PrC-210 thiol form, its free sulfhydryl group was protected by derivatization with N-ethylmaleimide (NEM), which produced the stable, quantifiable, PrC-210-NEM thioether conjugate. The PrC-210-NEM conjugate, and acyclovir used as an internal standard, were extracted from plasma or tissue homogenate with acetonitrile/0.1% formic acid.Results: The reconstituted dried extracts were chromatographed and then monitored using a triple quadrupole spectrometer operating in the positive ion spray ionization mode. The method was validated over the concentration range of 7.5 nM-5000 nM. Inter- and intra-assay precision and accuracy of PrC-210-NEM quantitation were better than 10%. The limit of PrC-210-NEM quantitation was 2.5 nM.Conclusions: The method was applied to measure plasma and tissue homogenate concentrations of PrC-210 in over 126 mice administered either oral, itraperitoneal, or subcutaneous PrC-210 doses.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"27-33"},"PeriodicalIF":1.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12998020/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146177643","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A fully automated novel solid-phase extraction method for siRNA drug extraction and quantitation across multiple tissues using LC-MS. 一种全自动的新型固相萃取方法，用于多组织siRNA药物的提取和定量。

IF 1.8 4区医学

Bioanalysis Pub Date : 2026-01-01 Epub Date: 2026-02-26 DOI: 10.1080/17576180.2026.2636553

Tony Karlsborn, Carl L Stenbratt, Amalyn Nain-Perez, Mikko Hölttä

{"title":"A fully automated novel solid-phase extraction method for siRNA drug extraction and quantitation across multiple tissues using LC-MS.","authors":"Tony Karlsborn, Carl L Stenbratt, Amalyn Nain-Perez, Mikko Hölttä","doi":"10.1080/17576180.2026.2636553","DOIUrl":"10.1080/17576180.2026.2636553","url":null,"abstract":"Background: Approaches such as liquid-liquid extraction and two-step liquid-liquid extraction combined with SPE has been widely used for extraction of oligonucleotide therapeutics. It has been more challenging to develop a generic one-step SPE method that can be used across multiple tissue types.Materials & methods: An SPE method was developed for extraction of oligonucleotide therapeutics from tissue homogenates utilizing an ASO internal standard and a siRNA analyte. The method was fully automated using a liquid handler and an automated SPE station. Quantification of the siRNA antisense was performed using LC-MS, with calibration samples prepared in a surrogate matrix.Results: The fully automated SPE method enabled quantification of the siRNA antisense across nine different tissues from three different species. The SPE method utilizing surrogate matrix calibration was compared to liquid-liquid extraction by analyzing in-vivo samples using both workflows, showing good agreement between the two different extraction methods.Conclusions: This manuscript presents a one-step SPE method greatly reducing blank tissue requirements and sample preparation workload by enabling use of surrogate matrix calibration and full automation. The presented SPE method simplifies and reduces analytical time in bioanalysis of tissue biodistribution studies and adheres to the principles of 3R.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"147-157"},"PeriodicalIF":1.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12998004/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147301712","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Strategy for streamlining antibody-drug conjugate pharmacokinetic assays. 简化抗体-药物偶联药代动力学分析的策略。

IF 1.8 4区医学

Bioanalysis Pub Date : 2026-01-01 Epub Date: 2026-02-18 DOI: 10.1080/17576180.2026.2631640

Weifeng Xu, Linlin Luo, Murali Matta, Roy Helmy, Faye Vazvaei-Smith

{"title":"Strategy for streamlining antibody-drug conjugate pharmacokinetic assays.","authors":"Weifeng Xu, Linlin Luo, Murali Matta, Roy Helmy, Faye Vazvaei-Smith","doi":"10.1080/17576180.2026.2631640","DOIUrl":"10.1080/17576180.2026.2631640","url":null,"abstract":"Antibody-drug conjugates (ADCs) have reemerged as a transformative therapeutic modality, with over a dozen approvals and hundreds of candidates in clinical development. Historically, ADC pharmacokinetic (PK) evaluation required measuring all constituent components - total antibody (TAb), conjugated antibody (ADC), or conjugated payload, free payload, and major metabolites. This comprehensive approach led to a significantly higher bioanalytical (BA) investment, increased patient blood volume requirements, and far more resources than those needed for monoclonal antibody (mAb) therapeutics or small molecule drugs. In 2024, the US Food and Drug Administration (FDA) issued guidance encouraging a more streamlined, data-driven approach to ADC PK assessment in clinical development, including the potential to omit certain analytes when scientifically justified. While this guidance represents a pivotal shift, adoption across the industry has been slow, and few examples of successful assay reduction have been publicly shared. In this perspective, we examine the scientific and regulatory rationale for simplifying ADC PK strategies. We also propose a pragmatic framework for reducing assays - grounded in clinical relevance, early-phase data, and platform knowledge - that seeks to reduce complexity without compromising patient safety or data integrity.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"179-188"},"PeriodicalIF":1.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12998008/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146218416","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Nitrogen blowing DµSPE of sunitinib, imatinib, and dasatinib using LDH/MIL-101(Cr)-NO₂ composite prior to HPLC-PDA. 在HPLC-PDA之前，使用LDH/MIL-101(Cr)-NO2复合物对舒尼替尼、伊马替尼和达沙替尼进行氮吹DµSPE。

IF 1.8 4区医学

Bioanalysis Pub Date : 2026-01-01 Epub Date: 2026-02-26 DOI: 10.1080/17576180.2026.2631964

Hakimeh Mottagi Khosrowshahi, Jafar Abolhasani, Mohammad Reza Afshar Mogaddam, Ebrahim Ghorbani Kalhor, Elnaz Ghasemi

{"title":"Nitrogen blowing DµSPE of sunitinib, imatinib, and dasatinib using LDH/MIL-101(Cr)-NO2 composite prior to HPLC-PDA.","authors":"Hakimeh Mottagi Khosrowshahi, Jafar Abolhasani, Mohammad Reza Afshar Mogaddam, Ebrahim Ghorbani Kalhor, Elnaz Ghasemi","doi":"10.1080/17576180.2026.2631964","DOIUrl":"10.1080/17576180.2026.2631964","url":null,"abstract":"Background: The therapeutic bioanalytical challenge activity of tyrosine kinase inhibitors (TKIs) can be assessed by measuring them in biological samples such as plasma and serum. Determining these compounds requires an efficient sample before the analysis to minimize matrix effects and enhance preconcentration. This study presents the use of a composite of layered double hydroxide (LDH) and metal organic framework (MOF) composite for extracting and preconcentrating of sunitinib, imatinib, and dasatinib.Methodology: The proposed composite was synthesized through the in-situ growth of MIL-101(Cr)-NO2 MOF on the MgFe-LDH surface. The extraction process involves adding 5 mg of LDH/MIL-101(Cr)-NO2 to the plasma solution containing the analytes, under nitrogen blowing. Centrifugation separated the analyte-loaded sorbent, which was then eluted with 125 μL of mobile phase. The organic phase was used subsequent high performance liquid chromatography (HPLC) - photo diode array detector (PDA) analysis.Results: Under optimum conditions, the developed method demonstrates favorable extraction recoveries (66-74%), low limits of detection (LOD) and quantification (LOQ) (0.46-0.69 ng mL-1 and 1.5-2.2 ng mL-1, respectively), wide linear ranges (LRs) (1.5-200 ng mL-1) with high coefficients of determination (0.997-0.999) and proper repeatability (RSD ≤ 6.6%).Conclusions: Notably, the method provides the use of minimal amounts of sorbent and solvents, short extraction time, no need for complicated instruments, and high performance in monitoring anti-cancer drugs in biological samples.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"169-177"},"PeriodicalIF":1.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12997966/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147301756","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Development of a chromatographic method for the analysis of risdiplam in serum extracts. 血清提取物中利西泮色谱分析方法的建立。

IF 1.8 4区医学

Bioanalysis Pub Date : 2026-01-01 Epub Date: 2026-02-05 DOI: 10.1080/17576180.2026.2624594

Natalia Balińska, Anna Lemska, Maria Mazurkiewicz-Bełdzińska, Sylwia Studzińska

{"title":"Development of a chromatographic method for the analysis of risdiplam in serum extracts.","authors":"Natalia Balińska, Anna Lemska, Maria Mazurkiewicz-Bełdzińska, Sylwia Studzińska","doi":"10.1080/17576180.2026.2624594","DOIUrl":"10.1080/17576180.2026.2624594","url":null,"abstract":"Background: Risdiplam has been used to treat spinal muscular atrophy for 3 years. There are limited number of papers devoted to its analytics. Until now, risdiplam and its metabolites have only been analyzed using a C18 column, while the sample preparation method involved protein precipitation.Research design and methods: Risdiplam was analyzed using reversed-phase UHPLC. The experiment was designed to compare the retention of risdiplam on five columns using various mobile phases. The protein precipitation was used as the sample preparation method.Results: Risdiplam shows greater retention on phenyl columns, where π-π interactions take part in retention. The increase of mobile phase pH caused increased risdiplam retention, while salt concentration had no significant effect. An octadecyl column with pentafluorophenyl groups was selected with a mobile phase containing 10 mM ammonium formate (pH 4) and acetonitrile. The method was characterized by good linearity, repeatability, and short analysis time. It was applied to risdiplam analysis in serum samples after protein precipitation with different solvents. Finally, proteins were effectively precipitated using 10% TFA solution, providing 90% recovery.Conclusions: The developed procedure of extraction and determination of risdiplam is simple, fast and reliable. It may find application for routine monitoring of risdiplam or for quality control.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"45-55"},"PeriodicalIF":1.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12997982/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146117581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Elucidating the in vivo fate of pharmaceutical excipient sodium carboxymethylcellulose in rats using UHPLC- Q TRAP MS/MS and UHPLC- Q TOF MS/MS approach. 采用UHPLC- Q TRAP MS/MS和UHPLC- Q TOF MS/MS方法研究药用辅料羧甲基纤维素钠在大鼠体内的命运。

IF 1.8 4区医学

Bioanalysis Pub Date : 2026-01-01 Epub Date: 2026-03-03 DOI: 10.1080/17576180.2026.2621015

Na Yang, Jingjing Liu, Kunqian Mu, Aixian Liang, Guo Yin, Xiaowei Wang, Ran Liu

{"title":"Elucidating the in vivo fate of pharmaceutical excipient sodium carboxymethylcellulose in rats using UHPLC- Q TRAP MS/MS and UHPLC- Q TOF MS/MS approach.","authors":"Na Yang, Jingjing Liu, Kunqian Mu, Aixian Liang, Guo Yin, Xiaowei Wang, Ran Liu","doi":"10.1080/17576180.2026.2621015","DOIUrl":"10.1080/17576180.2026.2621015","url":null,"abstract":"Aim: Sodium carboxymethylcellulose acts as both a pharmaceutical excipient (interacting with drugs to affect metabolism) and an active substance (stimulating intestinal peristalsis via aqueous polymeric colloids). To clarify its in vivo fate and advance sodium carboxymethylcellulose-based adjuvant delivery, a targeted analysis was needed, using dextromethorphan hydrobromide as a model drug.Research design and method: A comprehensive LC-MS approach was established: UHPLC-Q TRAP MS/MS (quantitative) and HPLC-Q TOF MS/MS (qualitative) were used to study sodium carboxymethylcellulose pharmacokinetics, distribution, metabolism, and excretion in male Wistar rats, with/without co-administered dextromethorphan hydrobromide.Results: The distribution of sodium carboxymethylcellulose is expedited to organs characterized by augmented blood flow velocities, including the spleen, liver, and heart. And about 66.4% sodium carboxymethyl cellulose was removed from plasma within 36 h. Results also showed that the excretion level of sodium carboxymethyl cellulose is less than the dosage administered, and almost all glycosidic bonds had been hydrolyzed in its process.Conclusion: The findings provide complete description of sodium carboxymethylcellulose in vivo fate, establishing a novel framework that facilitates the extensive utilization of this pharmaceutical excipient in the process of drug formulation development.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1-15"},"PeriodicalIF":1.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12997971/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147343481","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0