Chirality最新文献_第5页

Enantioselective Crystal Growth Induced by Mesoscopic Helical Platforms 介观螺旋平台诱导的对映选择性晶体生长。

IF 2.4 4区化学

Chirality Pub Date : 2026-07-03 DOI: 10.1002/chir.70120

Anthony Boudier, Guillaume Raffy, Emilie Pouget, Sylvain Nlate, Dario M. Bassani, Reiko Oda

{"title":"Enantioselective Crystal Growth Induced by Mesoscopic Helical Platforms","authors":"Anthony Boudier, Guillaume Raffy, Emilie Pouget, Sylvain Nlate, Dario M. Bassani, Reiko Oda","doi":"10.1002/chir.70120","DOIUrl":"10.1002/chir.70120","url":null,"abstract":"<p>We report enantioselective crystallization of tetraphenylethylene (TPE) directed by chiral silica nanohelices (SNHs), yielding crystalline assemblies with distinct morphologies and chiroptical signatures that are modulated by both template handedness and evaporation kinetics. When TPE solutions are deposited onto SNH-functionalized substrates and allowed to crystallize through slow solvent evaporation at 4°C, small orthorhombic crystals (2–5 μm) form with strong induced electronic circular dichroism (ECD) and circularly polarized luminescence (CPL) whose sign is correlated to the underlying SNH handedness. In contrast, rapid evaporation at room temperature leads to dendritic crystalline assemblies with strong ECD but weaker CPL with reduced correlation to the template handedness. Fluorescence microscopy confirms that emission originates exclusively from crystalline domains, consistent with restriction of intramolecular rotation upon crystal packing. The results show that right-handed (<i>P</i>-) and left-handed (<i>M</i>-)SNH preferentially promote the formation of distinct TPE enantiomeric crystals, providing a robust platform for template-directed chirality-controlled crystallization.</p>","PeriodicalId":10170,"journal":{"name":"Chirality","volume":"38 7","pages":""},"PeriodicalIF":2.4,"publicationDate":"2026-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/chir.70120","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148381704","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}

引用次数: 0

AQbD-Guided Chiral HPLC for Enantiomeric Impurity Analysis of Suzetrigine aqbd引导手性高效液相色谱法分析苏三嗪对映体杂质

IF 2.4 4区化学

Chirality Pub Date : 2026-06-25 DOI: 10.1002/chir.70118

Sultanah M. N. Alhunayhin, Ayman M. Algohary, Saja A. Althobaiti, Abdullah H. Alluhayb, Mona I. Shahin, Ahmed M. Ibrahim, Tamer H. A. Hasanin

{"title":"AQbD-Guided Chiral HPLC for Enantiomeric Impurity Analysis of Suzetrigine","authors":"Sultanah M. N. Alhunayhin, Ayman M. Algohary, Saja A. Althobaiti, Abdullah H. Alluhayb, Mona I. Shahin, Ahmed M. Ibrahim, Tamer H. A. Hasanin","doi":"10.1002/chir.70118","DOIUrl":"https://doi.org/10.1002/chir.70118","url":null,"abstract":"<div>\u0000 \u0000 <p>Suzetrigine (SUZ), an analgesic for acute pain, requires strict enantiomeric purity control. This study develops a robust chiral HPLC method for SUZ and its R-enantiomer using analytical quality by design (AQbD). Separation was achieved on a Chiralpak IC-3 column with an isocratic n-hexane–ethanol (90:10, v/v) mobile phase. The optimized method provided baseline resolution (<i>R</i><sub><i>s</i></sub> = 3.0) in 15 min. Validation via the accuracy profile approach confirmed reliable quantification, with limits of 290 μg mL<sup>−1</sup> (SUZ) and 0.32 μg mL<sup>−1</sup> (R-enantiomer). The AQbD strategy defined a method operable design region (MODR) ensuring robust routine performance. Furthermore, multimetric sustainability assessments demonstrated a favorable environmental profile, yielding blue applicability grade index (BAGI) and mosaic-WAC scores of 77.5 and 73.2, respectively. This approach enables reliable, eco-friendly enantiomeric purity assessment of SUZ in bulk and pharmaceutical formulations.</p>\u0000 </div>","PeriodicalId":10170,"journal":{"name":"Chirality","volume":"38 7","pages":""},"PeriodicalIF":2.4,"publicationDate":"2026-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148324429","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}

引用次数: 0

Recent Progress in the Total Synthesis and Biosynthesis of Arborisidine 树苷的全合成和生物合成研究进展。

IF 2.4 4区化学

Chirality Pub Date : 2026-06-21 DOI: 10.1002/chir.70119

Shiqi Dong, Kunxiao Shi, Ju Guo, Li Li

{"title":"Recent Progress in the Total Synthesis and Biosynthesis of Arborisidine","authors":"Shiqi Dong, Kunxiao Shi, Ju Guo, Li Li","doi":"10.1002/chir.70119","DOIUrl":"10.1002/chir.70119","url":null,"abstract":"<div>\u0000 \u0000 <p>As a significant representative of monoterpenoid indole alkaloids (MIAs) and 1,1-disubstituted tetrahydro-β-carboline (THβC) alkaloids, Arborisidine, since its discovery in 2016 by Kam and coworkers, has emerged as a focal molecule in the field of total synthesis due to its unique pentacyclic cage-like skeleton and the quaternary carbon center at C(16). Multiple research groups have conducted in-depth investigations into its total synthesis and successfully developed novel synthetic strategies. These studies have not only advanced the total synthesis and structural modification of this class of MIA natural products but also provided scientific approaches for structure–activity relationship (SAR) studies. Furthermore, with the rapid advancement of synthetic biology, investigations into the biosynthetic pathways of these alkaloids have not only offered innovative synthetic strategies for chemical synthesis but also delivered precise tools for structure-directed modification, thereby significantly accelerating structure-based drug design (SBDD). Based on this background, this review summarizes the recent advances in the total synthesis and biosynthetic studies of arborisidine, aiming to provide scientific insights for the synthesis of other family members through comparative analysis of diverse synthetic strategies, as well as to offer methodological support for drug design based on this structural framework.</p>\u0000 </div>","PeriodicalId":10170,"journal":{"name":"Chirality","volume":"38 7","pages":""},"PeriodicalIF":2.4,"publicationDate":"2026-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148293652","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}

引用次数: 0

Advances in Chiral Separation Techniques for Calcium Channel Blockers: Analytical Strategies and Future Perspectives in Antihypertensive Drug Development (2015–2025) 钙通道阻滞剂的手性分离技术进展：抗高血压药物开发的分析策略与未来展望（2015-2025）

IF 2.4 4区化学

Chirality Pub Date : 2026-06-20 DOI: 10.1002/chir.70113

Savita Umarani, Erica Alves, Manasa Chittipolu, P. Pattaluchetty, Gurupadayya Bannimath

{"title":"Advances in Chiral Separation Techniques for Calcium Channel Blockers: Analytical Strategies and Future Perspectives in Antihypertensive Drug Development (2015–2025)","authors":"Savita Umarani, Erica Alves, Manasa Chittipolu, P. Pattaluchetty, Gurupadayya Bannimath","doi":"10.1002/chir.70113","DOIUrl":"https://doi.org/10.1002/chir.70113","url":null,"abstract":"<div>\u0000 \u0000 <p>Chirality plays a crucial role in pharmaceutical development, as enantiomers often display distinct therapeutic, pharmacokinetic, and safety profiles. Calcium channel blockers (CCBs), a cornerstone in antihypertensive therapy, frequently possess one or more chiral centers, making enantioselective analysis essential for pharmacological and regulatory accuracy. Despite growing evidence of stereoselective differences, most marketed CCBs remain available as racemates, underscoring the need for refined analytical approaches. This review aims to bridge that gap by critically synthesizing advances in analytical, bioanalytical, and regulatory strategies for chiral CCBs. Key separation platforms—including high-performance liquid chromatography (HPLC), capillary electrophoresis (<span>CE</span>), gas chromatography (GC), and supercritical fluid chromatography (SFC)—are evaluated with emphasis on chiral stationary phases such as polysaccharides, cyclodextrins, macrocyclic antibiotics, and crown ethers. Recent innovations in hyphenated mass spectrometry, spectroscopic techniques, and eco-friendly miniaturized systems are highlighted for their ability to enhance enantioselectivity, reduce solvent consumption, and improve sensitivity in complex matrices. Case studies illustrate the pharmacokinetic and pharmacodynamic relevance of individual enantiomers, reinforcing the clinical impact of chirality in CCB therapy. The review concludes by identifying current limitations and exploring future directions, including AI-assisted selector design, green chemistry integration, and lab-on-chip platforms to advance personalized antihypertensive treatment.</p>\u0000 </div>","PeriodicalId":10170,"journal":{"name":"Chirality","volume":"38 7","pages":""},"PeriodicalIF":2.4,"publicationDate":"2026-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148282492","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}

引用次数: 0

Practical Enantioselective Approach to 3-Amino-2-Hydroxy Acids and Application to the Synthesis of Natural Products 3-氨基-2-羟基酸的实用对映选择方法及其在天然产物合成中的应用

IF 2.4 4区化学

Chirality Pub Date : 2026-06-17 DOI: 10.1002/chir.70115

Marilena Caporale, Giulia Marsico, Ernesto Santoro, Patrizia Scafato, Stefano Superchi

引用次数: 0

Capillary Chiral Separation of Agrochemicals: Complementary Insights From Molecular Modeling and NMR 农用化学品的毛细管手性分离：分子建模和核磁共振的互补见解

IF 2.4 4区化学

Chirality Pub Date : 2026-06-17 DOI: 10.1002/chir.70116

Imran Ali, Ann Gogolashvili, Lali Chankvetadze, Lasha Giunashvili, Nino Megeneishvili, Musa A. Said

{"title":"Capillary Chiral Separation of Agrochemicals: Complementary Insights From Molecular Modeling and NMR","authors":"Imran Ali, Ann Gogolashvili, Lali Chankvetadze, Lasha Giunashvili, Nino Megeneishvili, Musa A. Said","doi":"10.1002/chir.70116","DOIUrl":"https://doi.org/10.1002/chir.70116","url":null,"abstract":"<div>\u0000 \u0000 <p>The study investigates the capillary electrophoretic enantioseparation of agrochemicals (dichloroprop and mecoprop) using modified cyclodextrins 2-hydroxypropyl-β-cyclodextrin (CD-1), heptakis (2,3-di-O-methyl)-β-cyclodextrin (CD-2), heptakis (2,3-di-O-methyl-6-sulfo)-β-cyclodextrin (CD-3), and heptakis (2,3,6-tri-O-methyl)-β-cyclodextrin (CD-4) in 2-(N-morpholino)ethanesulfonic acid (MES) buffer. Migration times varied depending on the selector type and inclusion complex type and stability, reflecting differences in enantiomer–selector interaction strengths. The reversal of enantiomer migration order observed among the cyclodextrins suggested that even small structural differences in the chiral selectors influenced changes in intermolecular interactions and complex stability. This reversal order is useful for understanding the mechanisms. The separations were due to inclusion complexes with neutral cyclodextrins, while electrostatic interactions were responsible for negatively charged cyclodextrins. Docking and ROESY-NMR studies were used to provide supportive structural insight into the nature of chiral recognition mechanisms. The docking provided general structural information about the potential binding modes of these systems. However, native β-cyclodextrin was used for the ROESY-NMR studies because it produced very clear spectra, allowing the comparison of the basic interaction patterns among the various β-cyclodextrin derivatives. Overall, the results demonstrated that capillary electrophoresis (CE) is a sensitive technique for investigating intermolecular interactions and gaining insight into enantioselective processes.</p>\u0000 </div>","PeriodicalId":10170,"journal":{"name":"Chirality","volume":"38 7","pages":""},"PeriodicalIF":2.4,"publicationDate":"2026-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148269322","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}

引用次数: 0

Chiral (Stereoselective) Drugs, Asymmetric Synthesis, and Racemic Resolution Methods 手性（立体选择）药物，不对称合成和外消旋拆分方法

IF 2.4 4区化学

Chirality Pub Date : 2026-06-17 DOI: 10.1002/chir.70109

Burcu Karayavuz, Cigdem Karaaslan Kirmizioglu

{"title":"Chiral (Stereoselective) Drugs, Asymmetric Synthesis, and Racemic Resolution Methods","authors":"Burcu Karayavuz, Cigdem Karaaslan Kirmizioglu","doi":"10.1002/chir.70109","DOIUrl":"https://doi.org/10.1002/chir.70109","url":null,"abstract":"<p>Chirality is of great importance in drug development since both biological targets in the organism and the majority of pharmacologically active compounds created today are chiral. The synthesis and resolution of chiral compounds are critical steps while developing chiral drugs, as the chirality of a molecule can significantly affect its efficacy, safety (side effects and toxicity), and metabolism. While one enantiomer has therapeutic properties, the other enantiomer might be harmful, toxic, or ineffective. In recent years, the trends towards developing single enantiomer drugs have increased in the pharmaceutical industry. Various synthetic strategies and racemic resolution techniques are employed to obtain optically pure chiral drugs. Regulatory authorities also give more priority to assessing the biological efficacy of each chiral drug's enantiomer. This review summarizes the asymmetric synthesis and racemic resolution methods for producing pure enantiomeric pharmaceutical active ingredients and their synthetic intermediates, with examples from the pharmaceutical industry. By examining current approaches and challenges in the field, we aim to provide a comprehensive understanding of the processes that ensure the production of safe and effective chiral-specific drugs.</p>","PeriodicalId":10170,"journal":{"name":"Chirality","volume":"38 7","pages":""},"PeriodicalIF":2.4,"publicationDate":"2026-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/chir.70109","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148269328","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}

引用次数: 0

Simultaneous Determination and Enantiomeric Separation of Five DL-Thiol Compounds Using UHPLC-HRMS With Chiral Derivatization in Sake: Dynamic Monitoring of Human Urine After Drinking 手性衍生UHPLC-HRMS同时测定清酒中5种dl -硫醇类化合物及其对映体分离：人饮后尿液动态监测。

IF 2.4 4区化学

Chirality Pub Date : 2026-06-16 DOI: 10.1002/chir.70112

Shuyun Xiao, Hang Shi, Shuyi Song, Jun Zhe Min

{"title":"Simultaneous Determination and Enantiomeric Separation of Five DL-Thiol Compounds Using UHPLC-HRMS With Chiral Derivatization in Sake: Dynamic Monitoring of Human Urine After Drinking","authors":"Shuyun Xiao, Hang Shi, Shuyi Song, Jun Zhe Min","doi":"10.1002/chir.70112","DOIUrl":"10.1002/chir.70112","url":null,"abstract":"<div>\u0000 \u0000 <p>Sake, a fermented alcoholic beverage made from rice and Aspergillus oryzae through microbial fermentation, contains thiol compounds that are the primary source of its distinctive sweet aroma. However, to date, there has been no report on the detection of chiral thiol compounds in sake. This study introduces a novel UHPLC-HRMS method utilizing the (R)-(5-(3-isothiocyanatopyrrolidin-1-yl)-5-oxopentyl) triphenylphosphonium (NCS-OTPP) chiral mass spectrometry probe for the simultaneous detection of five DL-thiol compounds in sake. Separation was achieved using a YMC Triart C18 column (2.0 × 150 mm, 1.9 μm), employing an isocratic elution method to isolate DD/LL-GSH, γ-L-Glu-L-Cys, DL-Cys, DL-Hcy, and DL-Ac-Cys. The method demonstrated excellent linearity (<i>R</i><sup>2</sup> ≥ 0.9992), intraday precision (0.43%–13.18%), and an average recovery rate of 91.62%–110.40%. A comparative analysis of DL-thiol compound content in seven different types of sake from various countries and manufacturers revealed the presence of five chiral thiol compounds—LL-GSH, γ-L-Glu-L-Cys, DL-Cys, DL-Hcy, and L-Ac-Cys—across Japanese and Korean sake, with L-Cys being the most abundant and D-Ac-Cys the least. Notably, γ-L-Glu-L-Cys was detected only in two types of Korean sake and absent in Japanese sake. Additionally, the study investigated the metabolic kinetics of chiral thiol compounds in human urinary specimens after alcohol ingestion, constructing a metabolic fitting curve. The peak concentrations of DL-Cys, DL-Hcy, and LL-GSH were attained 15 min following consumption, with slow clearance, returning to baseline at 60 min. The metabolic fitting curve effectively captures the dynamic changes in urinary metabolism. This research presents a new method for detecting chiral thiol compounds in sake and monitoring urinary metabolism after alcohol consumption.</p>\u0000 </div>","PeriodicalId":10170,"journal":{"name":"Chirality","volume":"38 7","pages":""},"PeriodicalIF":2.4,"publicationDate":"2026-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148263607","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}

引用次数: 0

Palladium Schiff Base Complex–Modified Ti (MIL-125) Metal–Organic Frameworks as an Efficient Catalyst for Asymmetric Suzuki Coupling Reactions 钯希夫碱配合物修饰Ti （MIL-125）金属-有机骨架作为不对称铃木偶联反应的高效催化剂。

IF 2.4 4区化学

Chirality Pub Date : 2026-06-16 DOI: 10.1002/chir.70114

Jamal Kouhdareh

{"title":"Palladium Schiff Base Complex–Modified Ti (MIL-125) Metal–Organic Frameworks as an Efficient Catalyst for Asymmetric Suzuki Coupling Reactions","authors":"Jamal Kouhdareh","doi":"10.1002/chir.70114","DOIUrl":"10.1002/chir.70114","url":null,"abstract":"<div>\u0000 \u0000 <p>This work presents the design, synthesis, and catalytic evaluation of a novel heterogeneous organometallic catalyst, fabricated through the immobilization of a palladium–Schiff base complex onto the amino-functionalized titanium-based metal–organic framework, NH<sub>2</sub>-MIL-125. The resulting composite material was thoroughly characterized using a suite of analytical techniques, including FT-IR, XRD, FE-SEM, TGA, ICP-OES, EDS, and BET surface area analysis, confirming the successful modification and preservation of the MOF architecture. The catalyst demonstrated exceptional performance in facilitating asymmetric Suzuki–Miyaura cross-coupling reactions, proving to be both highly active and stereoselective. The enantiomeric excess (e.e.) of the produced axially chiral biaryls was quantified via high-performance liquid chromatography (HPLC) employing chiral stationary phases. Remarkably, the catalyst afforded biaryl derivatives with excellent enantioselectivity, achieving values up to 95% e.e. These findings underscore the potential of this MOF-based organopalladium nanocomposite as an efficient, reusable, and selective heterogeneous catalyst for the sustainable synthesis of valuable enantiomerically enriched biaryl compounds.</p>\u0000 </div>","PeriodicalId":10170,"journal":{"name":"Chirality","volume":"38 7","pages":""},"PeriodicalIF":2.4,"publicationDate":"2026-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148263612","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}

引用次数: 0

A Novel, Robust, and Isocratic HPLC-UV Method for the Comprehensive Determination of Enantiomeric Impurity (R-Isomer) in Niraparib Drug Substance 一种新型、稳健、等密度HPLC-UV综合测定尼拉帕尼原料药中对映异构体杂质（r -异构体）的方法。

IF 2.4 4区化学

Chirality Pub Date : 2026-06-16 DOI: 10.1002/chir.70110

Praveen Kumar Kondaveti, Paul Douglas, Akula Raghunadh, L. Kalyanaraman

{"title":"A Novel, Robust, and Isocratic HPLC-UV Method for the Comprehensive Determination of Enantiomeric Impurity (R-Isomer) in Niraparib Drug Substance","authors":"Praveen Kumar Kondaveti, Paul Douglas, Akula Raghunadh, L. Kalyanaraman","doi":"10.1002/chir.70110","DOIUrl":"10.1002/chir.70110","url":null,"abstract":"<div>\u0000 \u0000 <p>Niraparib is a potent, orally bioavailable inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, specifically targeting PARP-1 and PARP-2 to induce selective cytotoxicity in malignancies by disrupting DNA repair mechanisms. Given that the S-niraparib exhibits significantly higher pharmacological activity than the R-isomer, the development of a precise analytical technique to ensure enantiomeric purity is a critical requirement for pharmaceutical quality control. This study details the development and validation of a stability-indicating chiral high-performance liquid chromatography (HPLC) method for the quantitative assessment of enantiomeric purity content. Separation was successfully achieved using a Chiralpak AS-H 250 × 4.6 mm, 5 μm column under isocratic conditions with a mobile phase consisting of n-hexane, ethanol, methanol, and diethylamine in a 750:100:150:1.0 (v/v/v/v) ratio. The system was operated at a flow rate of 0.7 mL/min and a controlled column temperature of 40°C, with detection monitored via a UV/visible detector at 240 nm. The method was rigorously validated in accordance with ICH Q2(R2) guidelines, demonstrating specificity, accuracy, and precision. A resolution factor of greater than 2.0 was maintained between niraparib and its isomer. Analytical sensitivity was established through the determination of the limit of detection (LOD) and limit of quantitation (LOQ) using signal-to-noise ratios of 3 and 10, respectively, with a 1 mg/mL sample concentration and a 10 μL injection volume. Calibration curves proved linear over the studied range, confirming the method's reliability. The results indicate that this stability-indicating approach is highly effective for routine in-process quality control, batch release testing, and long-term stability monitoring of niraparib drug substances.</p>\u0000 </div>","PeriodicalId":10170,"journal":{"name":"Chirality","volume":"38 7","pages":""},"PeriodicalIF":2.4,"publicationDate":"2026-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148263558","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}

引用次数: 0