Chromatographia最新文献

{"title":"Correction: Lift Force on Spherical Particle in Nonlinear Velocity Gradient of Laminar Liquid Flow: Application to Field-Flow Fractionation","authors":"Josef Janča","doi":"10.1007/s10337-026-04505-z","DOIUrl":"10.1007/s10337-026-04505-z","url":null,"abstract":"","PeriodicalId":518,"journal":{"name":"Chromatographia","volume":"89 5","pages":"605 - 605"},"PeriodicalIF":1.6,"publicationDate":"2026-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s10337-026-04505-z.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148695241","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Simultaneous Determination of Eleven Biogenic Amines via Underivatized HILIC-MS/MS Without Ion-Pairing Reagents","authors":"Chunyan Chen,&nbsp;Yu Luo,&nbsp;Min Zhang,&nbsp;Zhibin Liu,&nbsp;Mengyue Hu,&nbsp;Jinlin Li","doi":"10.1007/s10337-026-04499-8","DOIUrl":"10.1007/s10337-026-04499-8","url":null,"abstract":"<div><p>In present research, a hydrophilic interaction liquid chromatography-tandem mass spectrometry (HILIC-MS/MS) method was proposed for the concurrent determination of 11 biogenic amines, including putrescine (PUT), cadaverine (CAD), histamine (HIS), 2-phenethylamine (2-PHE), tyramine (TYR), spermidine (SPD), octopamine (OA), 5-hydroxytryptamine (5-HT), adrenaline (A), tryptamine (TRP), and spermine (SPM) within 11 min. A Waters ACQUITY UPLC^® BEH Amide (100 mm × 2.1 mm i.d., 1.7 μm) was used as stationary phase. Gradient elution was conducted using a mobile phase of 90% acetonitrile aqueous solution (10 mM ammonium formate, 0.6% formic acid) and aqueous solution (300 mM ammonium formate). This method provides symmetrical peak shapes and satisfactory separation for all the biogenic amines. Furthermore, it displays high linearity (R² &gt; 0.97) except spermine and sensitivity (LODs ≤ 3 ng/mL). Importantly, the approach is convenient, rapid, and sensitive, without derivatization or ion-pairing reagents. Thus, the proposed HILIC-MS/MS method shows significant potential for both targeted and untargeted analysis of highly charged, small polar basic organic compounds in food safety supervision, metabolomics, environmental analysis, clinical research and relevant areas.</p></div>","PeriodicalId":518,"journal":{"name":"Chromatographia","volume":"89 5","pages":"589 - 596"},"PeriodicalIF":1.6,"publicationDate":"2026-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148695244","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating Different C18 Columns for the LC Separation of Δ9-THC and Other Related Cannabinoids","authors":"Walter B. Wilson","doi":"10.1007/s10337-026-04498-9","DOIUrl":"10.1007/s10337-026-04498-9","url":null,"abstract":"<div><p>The best separation possible of delta-9-tetrahydrocannabinol (Δ⁹-THC) in complex samples via liquid chromatography (LC) is particularly challenging due to the potential for interference from other cannabinoids. Over 100 cannabinoids have been detected in <i>Cannabis sativa</i> plant samples. The separation of Δ⁹-THC in <i>Cannabis</i>-derived finished products was believed to be easier than plant extracts to analyze at one time because the acidic cannabinoids are converted to their neutral cannabinoids during material preparation. However, the emergence of synthetic or semi-synthetic cannabinoid products, such as delta-8-tetrahydrocannabinol (Δ⁸-THC), has led to more chromatographic interferences due to the presence of synthetic by-products. The original LC separation method implemented in the Chemical Sciences Division (CSD) at the National Institute of Standards and Technology (NIST) was not acceptable when these chromatographic interferences were present. Within this context, the work presented here explores initial separation of an 11 cannabinoid mixture using different monomeric and polymeric octadecylsilane (C₁₈) columns via liquid chromatography. These columns were characterized using the Standard Reference Material 869b as a three-component column selectivity test mixture to determine if an LC C₁₈ column is classified as monomeric or polymeric. Monomeric C₁₈ columns (NexLeaf C₁₈, ACE 3 C₁₈, and ACE Super C₁₈) provided better separations of the 11 cannabinoids, and baseline separations were obtained in less than 13 min after minor adjustments to the mobile phase program. Using the NexLeaf C₁₈ LC-UV method, mixtures of Δ⁹-THC and four known chromatographic interferences were analyzed. Cannabinolic acid (CBNA) could not be separated from Δ⁹-THC; however, CBNA has drastically different absorbance spectra from Δ⁹-THC, and the co-elution of these cannabinoids can easily be recognized using photodiode array detection. When CBNA is present, the sample can be reanalyzed using an alternate NexLeaf C₁₈ LC-UV method developed here, which baseline-resolves Δ⁹-THC and CBNA in 60 min. These two LC-UV methods will be further evaluated at NIST CSD through quantitative comparisons in future publications, enabling their use in the development of reference materials for <i>Cannabis</i> plants and/or <i>Cannabis</i>-derived finished products.</p></div>","PeriodicalId":518,"journal":{"name":"Chromatographia","volume":"89 5","pages":"579 - 588"},"PeriodicalIF":1.6,"publicationDate":"2026-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13344130/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148410243","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bioanalytical Method Development for Simultaneous Estimation of Standard First-Line Anti-Tuberculosis Drugs in Human Plasma Using Liquid Chromatography-Tandem Mass Spectrometry","authors":"Rinu Mary Xavier,&nbsp;Debangana Pal,&nbsp;Bhavatharini Sukumaran,&nbsp;Mohit Ananda,&nbsp;Aryan Jangra,&nbsp;Krishnaveni Nagappan,&nbsp;B Babu,&nbsp;Deepalakshmi Mani","doi":"10.1007/s10337-026-04497-w","DOIUrl":"10.1007/s10337-026-04497-w","url":null,"abstract":"<div><p>Standardized tuberculosis treatment involves four major drugs: rifampicin, isoniazid, pyrazinamide, and ethambutol. Suboptimal concentrations of these drugs are one of the reasons for treatment failure, relapse, or resistance to the disease, though most patients respond to treatment. It is necessary to monitor the concentrations of these drugs and make the required dose adjustments to achieve the desired therapeutic effect. We developed and validated a simple and practical LC–MS/MS method for the simultaneous estimation of these four main drugs. A single-step protein precipitation technique was employed, using methanol as the precipitating agent to extract the drugs from the plasma sample. Chromatographic separation was achieved on a Phenomenex Luna® C18 column (150 × 4.6 mm, 3 µm) using a mobile phase composed of 0.1% formic acid in water and methanol, following isocratic elution. The flow rate was fixed at 0.7 mLmin⁻¹, and the run time was 5 min. Quantification was performed in ESI (+ ve) mode. The method demonstrated good linearity, with R² between 0.9912 and 0.9969. The mean extraction recoveries for all analytes ranged from 85.84% to 97.49%, and they were reproducible and consistent; no significant matrix effects were observed. Stability studies: bench-top (5 h), autosampler (26 h), freeze–thaw (3 cycles), and long-term stability in plasma (10 days) met the % CV acceptance criteria of ± 15%. The developed LC–MS/MS method was successfully applied to a healthy volunteer study administered with these drugs.</p></div>","PeriodicalId":518,"journal":{"name":"Chromatographia","volume":"89 5","pages":"563 - 578"},"PeriodicalIF":1.6,"publicationDate":"2026-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s10337-026-04497-w.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148695273","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Determination of Molecular Weight Distribution for Glatiramer Acetate by Size-Exclusion Chromatography Coupled to Multi-Angle Light Scattering and RI Detector (SEC-MALS-RI)","authors":"V. Umamaheshkumar,&nbsp;Mithun Rudrapal","doi":"10.1007/s10337-026-04496-x","DOIUrl":"10.1007/s10337-026-04496-x","url":null,"abstract":"<div><p>Glatiramer acetate (GA) is a heterogeneous synthetic polypeptide used as a disease-modifying therapy for relapsing forms of multiple sclerosis, and its molecular weight distribution (MWD) is a key attribute for demonstrating lot consistency and comparability across reference and follow-on products. In this work, GA MWD was characterized by size-exclusion chromatography coupled online to multi-angle light scattering and refractive index detection (SEC-MALS-RI), enabling calibration-independent (absolute) molar-mass determination across the elution profile. GA exhibited a broad, asymmetric SEC envelope consistent with inherent compositional and chain-length heterogeneity. Using RI-derived concentration (refractive index increment (dn/dc) established by a linear RI response–concentration relationship with <i>R</i>² = 1.0000; dn/dc ≈ 0.1834 mL/g, fit error ~ 0.38%), absolute molar-mass moments were obtained across defined peak regions: number-average molecular weight, Mn≈6.34–7.56 kDa; weight-average molecular weight, Mw≈8.90–9.56 kDa; with polydispersity index, Mw/Mn≈1.26–1.41; and average molecular weight, Mz≈12.34–14.49 kDa, indicating a measurable contribution from higher-mass species. Repeatability and intermediate precision were strong, with day-wise %RSD values &lt; 2% for Mn and Mw (<i>n</i> = 6/day across three days). Robustness testing showed that small dn/dc perturbations (± 0.005 mL/g around nominal) produced &lt; 2% change in Mw under stable integration and detector alignment. A BSA performance check yielded Mw/Mn = 1.005, supporting detector normalization and inter-detector synchronization. Overall, SEC-MALS-RI provides a reliable, absolute approach to quantify GA MWD and supports scientifically defensible comparability assessments for complex generic development and lifecycle quality control.</p></div>","PeriodicalId":518,"journal":{"name":"Chromatographia","volume":"89 5","pages":"555 - 562"},"PeriodicalIF":1.6,"publicationDate":"2026-06-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148695094","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Simultaneous LC–MS/MS Determination of Primary Leachables from Pharma Receptacles: 2-Mercaptobenzothiazole and 1,3-Diphenylguanidine","authors":"Hemasree Kommalapati,&nbsp;Sowmya Chaganti,&nbsp;Pushpa Pilli,&nbsp;Kavita Pimpre,&nbsp;Gananadhamu Samanthula","doi":"10.1007/s10337-026-04494-z","DOIUrl":"10.1007/s10337-026-04494-z","url":null,"abstract":"<div><p>This study addresses the issue of hazardous leachables specifically 2-mercaptobenzothiazole and 1,3-diphenylguanidine, which originate from vulcanizing agents and additives in pharmaceutical container materials. These compounds can negatively affect the quality and safety of pharmaceutical products by leaching out within the temperature range of 30–70 °C, which overlaps with typical daily life conditions. We developed a sensitive and robust UHPLC–MS/MS mass spectrometric method for the simultaneous quantification of primary leachables in pharmaceutical container systems. Chromatographic separation was performed on an ACQUITY UPLC CSH C₁₈ column (2.1 × 100 mm, 1.7 µm) using a binary mobile phase consisting of 0.1% formic acid in water (solvent A) and acetonitrile (solvent B) under a gradient elution program at a flow rate of 0.15 mL/min. Detection was carried out on a triple quadrupole mass spectrometer operated in a selective reaction monitoring (SRM) mode, ensuring high sensitivity and selectivity for target analytes. The developed UHPLC–MS/MS (ultra-liquid chromatography coupled with tandem mass spectrometry) method was validated and applied to quantify targeted compounds in selected pharmaceutical containers. This method demonstrated limits of detection (LOD) ranging from 1.13 to 1.18 ppb for the leachables, with a linearity range of 0.001 µg/mL–2 µg/mL. In this investigation, the detected leachables exceeded the established safety concern threshold (SCT), indicating that the pharmaceutical containers may pose potential toxicological risks to patients.</p></div>","PeriodicalId":518,"journal":{"name":"Chromatographia","volume":"89 5","pages":"533 - 542"},"PeriodicalIF":1.6,"publicationDate":"2026-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148695713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Green Monitoring of Residual BTEX Solvents in Injectable Antibiotics via Functionalized Carbon Fiber Microextraction and GC-FID: Optimization and Validation","authors":"Mohammad Reza Vardast,&nbsp;Arezu Fasihi Agbolagh","doi":"10.1007/s10337-026-04495-y","DOIUrl":"10.1007/s10337-026-04495-y","url":null,"abstract":"<div><p>This study presents a green, near-solvent-free method for quantifying residual BTEX solvents (benzene, toluene, ethylbenzene, and xylene) in injectable antibiotic vials using gas chromatography with flame ionization detection (GC-FID) coupled with solid-phase microextraction (SPME). Among five fabricated functionalized carbon fibers, the fiber coated with a graphene oxide/pyrrole/aniline nanocomposite (Fiber 4) demonstrated superior adsorption capacity. Optimized extraction parameters were established as follows: fiber length 1.5 cm, sample temperature 50 °C, extraction time 15 min, stirring speed 500 rpm, and 20% w/v NaCl (0.5 g per 2 mL sample). Method validation confirmed excellent sensitivity, with limits of detection (LODs) and quantification (LOQs) in the ranges of 0.02–0.15 µg/L and 0.09–0.45 µg/L, respectively. All concentrations refer to standard solution levels; for solid antibiotic samples (100 mg in 2 mL), these correspond to LODs of 0.001–0.0075 µg/g and LOQs of 0.0045–0.0225 µg/g. The method exhibited linearity from 0.1 to 500 µg/L (R² &gt; 0.999) and good precision, with relative standard deviations (RSDs) of 4.8–7.3% at 25 µg/L (n = 6). Successful application to real ampicillin and penicillin vials from two manufacturers yielded well-resolved chromatograms with minimal matrix interference. The method achieves detection limits well below ICH Q3C regulatory thresholds, uses minimal methanol (only for stock standards, &lt; 100 µL per batch), and offers a reproducible, economical, and environmentally friendly solution for monitoring Class 1 and 2 residual solvents in critical pharmaceutical products. Quantitative greenness assessment gave an Analytical Eco-Scale score of 85, an AGREE score of 0.78, and a favourable GAPI pictogram.</p><h3>Graphical Abstract</h3>\u0000<div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":518,"journal":{"name":"Chromatographia","volume":"89 5","pages":"543 - 554"},"PeriodicalIF":1.6,"publicationDate":"2026-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148695215","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lift Force on Spherical Particle in Nonlinear Velocity Gradient of Laminar Liquid Flow: Application to Field-Flow Fractionation","authors":"Josef Janča","doi":"10.1007/s10337-026-04493-0","DOIUrl":"10.1007/s10337-026-04493-0","url":null,"abstract":"<div><p>Historically exceptional observations of the blood movement in capillary vessels were revealed by Poiseuille. He found that blood corpuscles in flowing serum undergo only axial movement near the center of the vessels, whereas they rotate near the wall and in the intermediary space. This behavior generated the lift force. Poiseuille’s study of the effect of temperature gradient on the motion of the blood corpuscles resulted in the discovery of thermal diffusion. Recent investigation of the origin of the lift forces, applied on the ring-shaped two-dimensional particles, indicated an important difference between the theoretical and the experimental results and disclosed the necessity to take into account the three-dimensional sphere instead of the ring. The model of creeping flow of the liquid around the spherical particle is proposed to calculate the mean impact forces per unit area induced by the liquid streams in collisions with the surfaces of the upper and lower hemispheres of the particle. The difference of these forces between two hemispheres gives rise to the rotation of the particle and to the consequent lift force. This theoretical model approaches significantly the experimental data, but slightly deviates from them within the whole range of liquid flow velocities. The disaccord is due to the particle’s surface nature which is not smooth. The imperfections of the surface influence the effective particle size because the layer thickness of the species adhering to the surface can depend on the liquid flow velocity. Newton’s iteration method was used to obtain the correction factors. Then the first theoretical data calculation approach was corrected to obtain the second approach which fits almost perfectly the experimental data.</p></div>","PeriodicalId":518,"journal":{"name":"Chromatographia","volume":"89 5","pages":"597 - 604"},"PeriodicalIF":1.6,"publicationDate":"2026-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s10337-026-04493-0.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148695323","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Simultaneous Determination of Duloxetine and N-Nitroso-Duloxetine in Reactor Cleaning Solvent Samples by LC–HRMS: Formation, Quantitation, and Green Assessment","authors":"Nagaraju Rajana,&nbsp;Gayatri Gajanan Kulkarni","doi":"10.1007/s10337-026-04492-1","DOIUrl":"10.1007/s10337-026-04492-1","url":null,"abstract":"<div><p>The purpose of this study was to study the trace-level quantification of carcinogenic N-nitroso-duloxetine as well as the residual duloxetine HCl in different reactor material cleaning solvent samples. Duloxetine is a serotonin–norepinephrine reuptake inhibitor with a secondary amine group in its structure, which makes it susceptible to nitrosation in the presence of nitrosating agents, favored by low pH conditions. The sensitive LC–HRMS method was developed using an Agilent Poroshell C18 column with an isocratic elution (0.1% formic acid (FA) in water:0.1% FA in methanol: 20:80 v/v) with heated electrospray ionization as the ionization source coupled with Q-Orbitrap, and was also monitored at 298.1260 <i>m</i>/<i>z</i> for DXT and 349.0981 <i>m</i>/<i>z</i> for NDXT. The different reactor materials were selected for the recovery study. The developed method confirmed excellent linearity from 3 to 1000 ppb over the concentration range, with correlation coefficients of 0.9997 (DXT) and 0.9995 (NDXT), an LOD of 3 ppb, and an LOQ of 10 ppb. The recovery range of the method was from 71.5% to 95.6% in different reactor materials. The precision indicated by %RSD ranged from 0.7% to 5.6%. The robustness range was within 2.0%, confirming that the method is robust and reliable. The formation of NDXT from DXT has been studied, revealing significant NDXT formation from DXT at pH 2.5, 3.0, 5.0, and 7.3 in the presence of nitrite. This method facilitates the detection of NDXT and DXT in pharmaceutical manufacturing reactor cleaning samples and achieves an AGREE score of 0.75, reflecting its strong environmental friendliness through minimal sample use and reduced waste.</p></div>","PeriodicalId":518,"journal":{"name":"Chromatographia","volume":"89 5","pages":"521 - 532"},"PeriodicalIF":1.6,"publicationDate":"2026-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148695268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"QbD Steered Development and Validation of UPLC/MS Method with a Comprehensive FMEA Risk Assessment to Quantify the Degradation Impurities of Posaconazole from Tablet Formulation and Their Pathways","authors":"Surajkumar D. Jadhav,&nbsp;Shailesh Wadher","doi":"10.1007/s10337-026-04482-3","DOIUrl":"10.1007/s10337-026-04482-3","url":null,"abstract":"<div><p>This study introduces a novel isocratic ultra-performance liquid chromatography method coupled with photodiode array and electrospray ionization mass spectrometry (ESI/MS) for the quantification of the antifungal drug Posaconazole (PCZ) and its four degradation products in tablet formulations. Employing an innovative Analytical quality by design (AQbD) approach, we established robust chromatographic conditions for precise measurement of degradation impurities resulting from forced degradation processes, such as acid/alkali hydrolysis, peroxide oxidation and thermal/photo degradation. A comprehensive risk assessment was conducted using failure mode effects analysis to identify critical analytical attributes (CAAs) and their impact on analytical target profiles (ATPs). The interactions between the identified CMAs (CMA1—retention time of PCZ and degradant peak; CMA2—resolution between degradant peaks) and ATPs were explored using a Box–Behnken Design (BBD), which led to the selection of optimal chromatographic conditions. These consisted of a mobile phase comprising 20 mM ammonium formate buffer (pH 4.2), acetonitrile, and methanol (70:18:12 v/v/v), an X‑Bridge C18 column (150 × 4.6 mm, 3.5 µm), a detection wavelength of 260 nm, a flow rate of 1.0 mL/min, and an injection volume of 5 µL. Each risk factors were reevaluated, and control on each was relinquished. The validation of the method was performed according to ICH Q2 (R2) guidelines, confirming its specificity, precision, linearity, LOQ, LOD, and accuracy. The developed method was deemed stability-indicating and suitable for routine and stability testing of Posaconazole formulations.</p><h3>Graphical abstract</h3><div><figure><div><div><picture><source><img></source></picture><span>The alternative text for this image may have been generated using AI.</span></div></div></figure></div></div>","PeriodicalId":518,"journal":{"name":"Chromatographia","volume":"89 4","pages":"405 - 418"},"PeriodicalIF":1.3,"publicationDate":"2026-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148237194","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}