Journal of chromatographic science最新文献_第5页

Bioanalytical HPLC Method for Quantification of Benidipine in Rat Plasma: Stability and Application to Pharmacokinetic Study. 生物分析高效液相色谱法测定大鼠血浆中苯地平的稳定性及其在药动学研究中的应用。

IF 1.3 4区化学

Journal of chromatographic science Pub Date : 2025-11-15 DOI: 10.1093/chromsci/bmaf063

Khater Al-Japairai, Samah Hamed Almurisi, Ayah Rebhi Hilles, Nadiya Abdul-Halim, Syed Mahmood

{"title":"Bioanalytical HPLC Method for Quantification of Benidipine in Rat Plasma: Stability and Application to Pharmacokinetic Study.","authors":"Khater Al-Japairai, Samah Hamed Almurisi, Ayah Rebhi Hilles, Nadiya Abdul-Halim, Syed Mahmood","doi":"10.1093/chromsci/bmaf063","DOIUrl":"https://doi.org/10.1093/chromsci/bmaf063","url":null,"abstract":"Benidipine is a dihydropyridine calcium channel blocker widely used in management of hypertension, and its pharmacokinetic evaluation requires reliable quantification in plasma. Even though liquid chromatography-mass spectrometry methods are available, simple and cost-effective HPLC approaches for determining benidipine in rat plasma remain limited. To address this gap, a reversed-phase high-performance liquid chromatographic (HPLC) method was developed and validated to assess the presence of benidipine in rat plasma. Acetonitrile was used as the extracting solvent for the liquid-liquid extraction of the plasma's analytes, followed by separation on an HPLC column. Benidipine's retention time was found to be 8.134 min. The limit of detection and the limit of quantification were determined to be, respectively, 0.016 μg/mL and 0.047 μg/mL. The method was validated over a liner (R2 = 0.9995) concentration range of 0.05 to 10 μg/mL. The level of precision and accuracy were found to be within acceptable limits. Benidipine was found to be stable under freeze-thaw and short-term conditions. Benidipine's pharmacokinetic parameters were suitably assessed in Sprague-Dawley rats after a single oral dosage (0.822 mg/kg). The findings demonstrated the suitability and applicability of the developed bioanalytical HPLC approach as a tool for the pharmacokinetic analysis of benidipine.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":"63 10","pages":""},"PeriodicalIF":1.3,"publicationDate":"2025-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145762944","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

The Analytical Method Development for Genotoxic Impurities of Lapatinib Ditosylate Monohydrate by Reversed Phase High-Performance Liquid Chromatography. 反相高效液相色谱法测定一水二甲磺酸拉帕替尼遗传毒性杂质方法的建立。

IF 1.3 4区化学

Journal of chromatographic science Pub Date : 2025-11-15 DOI: 10.1093/chromsci/bmaf061

Siddharth Shah, Vaibhavi Savalia, Hitesh Vekariya

{"title":"The Analytical Method Development for Genotoxic Impurities of Lapatinib Ditosylate Monohydrate by Reversed Phase High-Performance Liquid Chromatography.","authors":"Siddharth Shah, Vaibhavi Savalia, Hitesh Vekariya","doi":"10.1093/chromsci/bmaf061","DOIUrl":"https://doi.org/10.1093/chromsci/bmaf061","url":null,"abstract":"An accurate, sensitive, and rapid reverse phase high-performance liquid chromatography method has been developed and validated for genotoxic impurities of Lapatinib ditosylate monohydrate. The present experiment utilizes the simple RP-HPLC technique. HPLC analysis was performed on a suitable column C-18. Column temperature maintained at 45°C. Chromatographic separation was achieved with mobile phase gradient program. The method suitability was validated according to the ICH guidelines Q2 (R2) for specificity, linearity, accuracy, precision, limit of quantification, limit of detection, and solution stability. Limit of detection of each impurity was found below 0.02 ppm, indicating that the developed method is highly sensitive without the use of any hyphenated technique. The calibration curve of each impurity was found to be linear within the concentration range of about 0.12 to 0.60 μg/mL. The regression data for calibration curve show good linear relationship. Correlation coefficient (r2) of each impurity was found above 0.99. The recovery of each impurity was found to be between 80% and 120%. The experiment results are given in detail in this research article.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":"63 10","pages":""},"PeriodicalIF":1.3,"publicationDate":"2025-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145763095","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

Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry Method for Quantification of 3,14,19-Triacetyl Andrographolide in Rat Plasma: Application to Preclinical Pharmacokinetic Studies. 超高效液相色谱-串联质谱法定量大鼠血浆中3,14,19-三乙酰穿心莲内酯：应用于临床前药代动力学研究。

IF 1.3 4区化学

Journal of chromatographic science Pub Date : 2025-11-15 DOI: 10.1093/chromsci/bmaf057

Chang Ren, Xin Sui, Kunlin Zhang, Jingjing Wang, Hao Li, Fenghe Yang, Mengjun Zhang, Junli Zhao, Yu Zhang, Guanhua Du, Guang Han

{"title":"Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry Method for Quantification of 3,14,19-Triacetyl Andrographolide in Rat Plasma: Application to Preclinical Pharmacokinetic Studies.","authors":"Chang Ren, Xin Sui, Kunlin Zhang, Jingjing Wang, Hao Li, Fenghe Yang, Mengjun Zhang, Junli Zhao, Yu Zhang, Guanhua Du, Guang Han","doi":"10.1093/chromsci/bmaf057","DOIUrl":"https://doi.org/10.1093/chromsci/bmaf057","url":null,"abstract":"3,14,19-triacetyl andrographolide (ADA), a derivative of andrographolide, has emerged as a promising anti-inflammatory compound. In the present study, we established a rapid and sensitive ultra-performance liquid chromatography-tandem mass spectrometry method for the quantification of ADA in rat plasma. ADA and celecoxib (internal standard, IS) were separated using an ACQUITY UPLC BEH C18 chromatographic columns with a gradient mobile phase of acetonitrile (containing 0.1% formic acid)/water (containing 0.1% formic acid) at a flow rate of 0.3 mL/min. Quantification was performed using the multiple reaction monitoring transitions to m/z 499.1 → 439.1 for ADA, m/z 381.9 → 361.9 for celecoxib, with plasma samples undergoing liquid-liquid extraction. The method effectively detected ADA in plasma and exhibited excellent linearity (R 2 > 0.9921) over concentrations ranging from 5 to 2000 ng/mL. Both within-run and between-run precision (%RSD) were less than 6.88%, and accuracy ranged from 94.86% to 107.61%. Matrix effects were 87.53% and 112.78%, with recoveries ranging from 98.60% to 104.39%. ADA was proven to be stable under different storage conditions (4°C and -70°C) in plasma. The validated method was successfully applied to determine ADA concentrations in rat plasma. The results demonstrated that ADA exhibited a noticeable improvement in bioavailability compared with andrographolide.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":"63 10","pages":""},"PeriodicalIF":1.3,"publicationDate":"2025-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145633891","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

Greenness Assessment of HPLC-UV Method for Simultaneous Estimation of Four Antihypertensive Drugs. HPLC-UV法同时测定4种降压药的绿色度评价。

IF 1.3 4区化学

Journal of chromatographic science Pub Date : 2025-11-15 DOI: 10.1093/chromsci/bmaf059

Kavita Suthar, Sonal Desai

引用次数: 0

Development and Validation of a Novel High-Performance Liquid Chromatography Assay with Ultraviolet Detection for Determination of Asciminib in Human Plasma. 新型高效液相色谱紫外检测法测定人血浆中阿西米尼的建立与验证。

IF 1.3 4区化学

Journal of chromatographic science Pub Date : 2025-11-15 DOI: 10.1093/chromsci/bmaf056

Masatomo Miura, Naoto Takahashi

{"title":"Development and Validation of a Novel High-Performance Liquid Chromatography Assay with Ultraviolet Detection for Determination of Asciminib in Human Plasma.","authors":"Masatomo Miura, Naoto Takahashi","doi":"10.1093/chromsci/bmaf056","DOIUrl":"10.1093/chromsci/bmaf056","url":null,"abstract":"A rapid, simple and highly sensitive stability-indicating high-performance liquid chromatography (HPLC) method was developed and validated for the estimation of asciminib in human plasma. Plasma samples (100 μL) were processed by solid-phase extraction. Chromatographic separation was performed using a CAPCELL PAK C18 MGII column (4.6 × 250 mm, 5 μm); the mobile phase consisted of 0.5% potassium dihydrogen phosphate (KH2PO4, pH 3.5): acetonitrile: methanol (50:45:5, v/v/v) at a flow rate of 0.5 mL/min. Detection was carried out at a wavelength of 250 nm. The developed method showed good linearity over the concentration range of 10-5000 ng/mL (correlation coefficient: 0.9999). The method was then validated according to guidelines published by the US Food and Drug Administration. The coefficients of variation for intra- and interday assays for asciminib were less than 13.9%, whereas accuracies for intra- and interday assays were within 8.9%. The limit of quantification was 10 ng/mL. The mean (minimum - maximum) plasma trough concentration of asciminib in 29 Japanese patients with chronic myeloid leukemia who received repeated administration of 40 mg twice daily was 367 (101-807) ng/mL. The validated method can be used as a routine method to support pharmacokinetic studies of asciminib.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":"63 10","pages":""},"PeriodicalIF":1.3,"publicationDate":"2025-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145564282","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

Simultaneous Determination of 8, 11, 12, 20-HETEs and 13 s-HODE in Paraquat and Diquat Poisoning Patients Via the UPLC-MS/MS Method. UPLC-MS/MS法同时测定百草枯和双菊枯中毒患者体内8、11、12、20-HETEs和13 s-HODE

IF 1.3 4区化学

Journal of chromatographic science Pub Date : 2025-10-07 DOI: 10.1093/chromsci/bmaf052

Zheng Yu, Xiaofang Ke, Minjie You, Tao Zhou, Jianhui Yang, Xianqin Wang, Congcong Wen, Xiuwei Shen, Xiuhua Zhang, Lufeng Hu

{"title":"Simultaneous Determination of 8, 11, 12, 20-HETEs and 13 s-HODE in Paraquat and Diquat Poisoning Patients Via the UPLC-MS/MS Method.","authors":"Zheng Yu, Xiaofang Ke, Minjie You, Tao Zhou, Jianhui Yang, Xianqin Wang, Congcong Wen, Xiuwei Shen, Xiuhua Zhang, Lufeng Hu","doi":"10.1093/chromsci/bmaf052","DOIUrl":"https://doi.org/10.1093/chromsci/bmaf052","url":null,"abstract":"An Ultra Performance Liquid Chromatography - Mass Spectrometry/Mass Spectrometry (UPL-MS/MS) method for simultaneous determination of 8, 11, 12, 20- hydroxyeicosatetraenoic acids (HETEs) and 13 s-hydroxyoctadecadienoic acid (13 s-HODE) in plasma was developed and optimized. The chromatographic separation of 8, 11, 12, 20-HETEs and 13 s-HODE was achieved on a Peptide Bridged Ethylene Hybrid Particles (BEH) C18 column (2.1 mm × 150 mm, 1.7 μm) with mobile phase A (Water containing 0.1% formic acid) and mobile phase B (acetonitrile containing 0.1% formic acid). HETEs and 13 s-HODE were quantified using multiple reaction monitoring mode. The developed UPLC-MS/MS method was applied to determine the plasma samples of 32 paraquat (PQ) poisoning patients, 20 diquat (DQ) poisoning patients and 38 healthy subjects. The results showed that the 8, 11, 12, 20-HETEs and 13 s-HODE have good linearity (R2 > 0.99) from 0.1-500 ng/mL. The levels of HETEs and 13 s-HODE were dramatically increased in PQ and DQ poisoning patients. There were high correlation between 8, 11, 12, 20-HETEs and 13 s-HODE. Orthogonal partial least squares discrimination analysis showed that three groups were distributed in different areas and separated well. In conclusion, a sensitive UPLC-MS/MS method had been developed and validated for determination of 8, 11, 12, 20-HETEs and 13 s-HODE in plasma of PQ and DQ patients.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":"63 9","pages":""},"PeriodicalIF":1.3,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145244242","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

Validated Environmentally Friendly Chromatographic Determinations of Dacarbazine and its Related Substances. 验证环境友好色谱法测定达卡巴嗪及其有关物质。

IF 1.3 4区化学

Journal of chromatographic science Pub Date : 2025-10-07 DOI: 10.1093/chromsci/bmaf053

Ibrahim A Naguib, Eglal A Abdelaleem, Eman S Hassan, Aml A Emam

{"title":"Validated Environmentally Friendly Chromatographic Determinations of Dacarbazine and its Related Substances.","authors":"Ibrahim A Naguib, Eglal A Abdelaleem, Eman S Hassan, Aml A Emam","doi":"10.1093/chromsci/bmaf053","DOIUrl":"10.1093/chromsci/bmaf053","url":null,"abstract":"Sensitive and specific eco-friendly chromatographic approaches were developed to quantitatively determine Dacarbazine along with its United States Pharmacopeia (USP) related impurities simultaneously. Method I was reveresed phase HPLC (RP-HPLC) by which separation of the ternary mixture was achieved. Zorbax Eclipse Plus octadecyl column as stationary phase, a mobile phase formed of double distilled water and methanol at a ratio of (70: 30, v/v) and 0.6 mL/min as a flow rate were used for isocratic separation. Ultra violet (UV) detection was adjusted at 230 nm. Method II is high performance thin layer chromatography (HPTLC), where the separation was performed on silica gel plates using green developing system composed of butanol: ethyl acetate: 0.05 M ammonium acetate (2: 4: 0.4, by volume) with UV detection at 280 nm. Green behavior of the developed techniques was evaluated. The International Council for Harmonisation (ICH) guidelines were considered for the proposed approaches validation. Moreover, Dacarbazine was successfully determined in Dacarbazine medac® powder for injection by the proposed techniques. No significant difference aroused between the results of the developed techniques and the results aroused from the official USP spectrophotometric method. Furthermore, the proposed methods had the merits of being more friendly towards the environment, sensitive and time saver than other reported HPLC methods.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":"63 9","pages":""},"PeriodicalIF":1.3,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145482297","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

Development of a Quantification Method for Procyanidin B1 and B3 in Pine Bark Extracts Using Heart-Cutting HPLC. 用切心高效液相色谱法测定松树皮提取物中原花青素B1和B3的含量。

IF 1.3 4区化学

Journal of chromatographic science Pub Date : 2025-10-07 DOI: 10.1093/chromsci/bmaf050

Ippei Suzuki, Yasuhito Kumai, Jun Takebayashi

{"title":"Development of a Quantification Method for Procyanidin B1 and B3 in Pine Bark Extracts Using Heart-Cutting HPLC.","authors":"Ippei Suzuki, Yasuhito Kumai, Jun Takebayashi","doi":"10.1093/chromsci/bmaf050","DOIUrl":"10.1093/chromsci/bmaf050","url":null,"abstract":"Pine bark extract (PBE) is a material used as a health food. Its functionality is attributed to the antioxidant effect of its contained procyanidins, and quantification of the procyanidin content is important to monitor its quality. However, conventional single-column High-Performance Liquid Chromatography (HPLC) methods often lack sufficient separation for procyanidins in complex matrices like PBE, leading to inaccurate quantification. In order to improve the accuracy of analysis for procyanidins B1 (PCB1) and B3 (PCB3) contained in PBE, we developed a highly accurate analytical method employing heart-cutting HPLC using columns with multiple properties and performed a detailed validation. The PCB1 and PCB3 contained in commercial health foods ranged from 0.43-2.95 mg/g, with a relative standard deviation of 0.77-6.17%. The spike and recovery tests showed that the recovery of beverages ranged from 98 to 106% at low and high concentrations, and for tablets, the recovery ranged from 95 to 118%. The repeatability relative standard deviation ranged from 1.10 to 3.57%, and the Horwitz Ratio ranged from 0.26-1.89. The intermediate relative standard deviation ranged from 2.62 to 6.83%. Single-laboratory validation of the analytical method employing heart-cutting HPLC showed that it is sufficiently accurate for analyzing PCB1 and PCB3 in commercial health foods containing PBE.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":"63 9","pages":""},"PeriodicalIF":1.3,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145354732","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

Genetic Neural Network-Assisted Natural Deep Eutectic Solvent Extraction for Enhanced Bioactive Yield from Folium Mori with Cytotoxicity Profiling. 遗传神经网络辅助天然深共熔溶剂萃取提高桑叶生物活性产率及细胞毒性分析。

IF 1.3 4区化学

Journal of chromatographic science Pub Date : 2025-08-30 DOI: 10.1093/chromsci/bmaf048

Yanxia Zhou, Jinglin Shen, Hongmei Chen, Ping Huang

引用次数: 0

A Simple and Highly Sensitive Liquid Chromatographic-Mass Spectrometric Method for the Determination of Itraconazole and Its Major Metabolite in Human Plasma and Its Application to a Bioequivalence Study. 高效液相色谱-质谱联用法测定人血浆中伊曲康唑及其主要代谢物及其生物等效性研究

IF 1.3 4区化学

Journal of chromatographic science Pub Date : 2025-08-30 DOI: 10.1093/chromsci/bmaf035

Hamed Hamishehkar, Rasoul Hosseinpour, Ladan Dayani, Bahareh Samii, Jaber Emami

{"title":"A Simple and Highly Sensitive Liquid Chromatographic-Mass Spectrometric Method for the Determination of Itraconazole and Its Major Metabolite in Human Plasma and Its Application to a Bioequivalence Study.","authors":"Hamed Hamishehkar, Rasoul Hosseinpour, Ladan Dayani, Bahareh Samii, Jaber Emami","doi":"10.1093/chromsci/bmaf035","DOIUrl":"https://doi.org/10.1093/chromsci/bmaf035","url":null,"abstract":"Itraconazole is an oral triazole antimycotic drug. Bioequivalence studies are cornerstones for the approval of generic drug development globally. The present study describes a simple, sensitive and economical LC-MS/MS method for the determination of itraconazole and its metabolite in human plasma. Itraconazole (drug), hydroxyitraconazole (metabolite), and atorvastatin as internal standard were added to plasma samples. The standard curve of both the drug and metabolite covering the 4-320 ng/mL concentration range, was linear (R2 = 0.999). Also, a limit of quantification of 4 ng/mL of a sample size of 0.4 mL is achieved which is comparable or even better than the reported methods. The applicability of this method was proven by analyzing true samples obtained after the administration of 100 mg itraconazole of test (Noxifunge®) and reference (Sporanox®) to healthy volunteers. The 90% confidence intervals of the logarithmically transformed AUC0-72, AUC0-∞, and Cmax of the two formulations both for the drug and the metabolite are within the accepted levels proposed by FDA and EMA. Therefore, the presented method is suitable for bioavailability, pharmacokinetic, and bioequivalent studies in humans.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":"63 8","pages":""},"PeriodicalIF":1.3,"publicationDate":"2025-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145000648","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