Journal of chromatographic science最新文献_第3页

Simultaneous Determination of D and L Enantiomers of 2-Hydroxyglutarate by UHPLC-MS/MS Method in Human Biological Fluids and its Clinical Application. 超高效液相色谱-质谱/质谱法同时测定人体生物液体中2-羟基戊二酸D和L对映体及其临床应用

IF 1.5 4区化学

Journal of chromatographic science Pub Date : 2025-01-09 DOI: 10.1093/chromsci/bmae013

Xiaoqing Li, Yunhai Bo, Le Le, Fen Yang

{"title":"Simultaneous Determination of D and L Enantiomers of 2-Hydroxyglutarate by UHPLC-MS/MS Method in Human Biological Fluids and its Clinical Application.","authors":"Xiaoqing Li, Yunhai Bo, Le Le, Fen Yang","doi":"10.1093/chromsci/bmae013","DOIUrl":"10.1093/chromsci/bmae013","url":null,"abstract":"2-hydroxyglutarate has limited abundance in normal tissues but a high level under certain pathologic conditions. To clarify the diagnostic value of two chiral isomers of 2-hydroxyglutarate in plasma and urine of Chinese cancer patients, an ultra-high performance liquid chromatography-tandem mass spectrometric method was developed for simultaneous quantification of D-/L-2-hydroxyglutarate. The selected D-/L-2-hydroxyglutarate-d5 as internal standards were added to samples before the SPE on Waters Oasis® MAX 96-Well plate (30 μm, 60 mg). A derivatization step with (+)-O,O'-diacetyl-L-tartaric anhydride permitted the chromatography separation of D-/L-2-hydroxyglutarate on an ACQUITY UPLC-HSS T3 column (50 × 2.1 mm, i.d. 1.8 μm) with acetonitrile and water (containing 0.1% formic acid and 10 mmol ammonium acetate) as the mobile phase. The calibration curves showed good linearity (R ≥ 0.99) over the concentration ranges of 200-5,000 ng/mL and 500-20,000 ng/mL for analysis of D-/L-2-hydroxyglutarate in plasma and urine samples, respectively. Intra- and inter-run precision were ≤ 12.33%, and the accuracy was within the range of -10.44 to 13.90%. This method was further successfully applied to clinical sample analysis in isocitrate dehydrogenase 1/2 mutated Chinese cancer patients.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140326637","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

UPLC-MS/MS Combined with Microdialysis for Determination of Two Active Components of Chuanxiong Rhizoma Extracts in Rat Brain: Application in Pharmacokinetic Study. 超高效液相色谱-质谱联用微透析法测定川芎提取物中两种有效成分在大鼠脑中的药动学研究

IF 1.5 4区化学

Journal of chromatographic science Pub Date : 2025-01-09 DOI: 10.1093/chromsci/bmae059

Yu Wang, Liang Jin, Xinhua Liu, Bing Shu, Jia Xu, Lingyun Pan

{"title":"UPLC-MS/MS Combined with Microdialysis for Determination of Two Active Components of Chuanxiong Rhizoma Extracts in Rat Brain: Application in Pharmacokinetic Study.","authors":"Yu Wang, Liang Jin, Xinhua Liu, Bing Shu, Jia Xu, Lingyun Pan","doi":"10.1093/chromsci/bmae059","DOIUrl":"10.1093/chromsci/bmae059","url":null,"abstract":"Chuanxiong Rhizoma (Chuanxiong), a traditional Chinese medicine, has been widely used to treat various nervous and cardiovascular system-related conditions. Its active components, senkyunolide A (SA) and 3-n-butylphthalide (NBP), have been proven effective in treating nervous system diseases. A new method was established based on microdialysis coupled with ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) to estimate the concentrations of these components in brain extracellular fluid. Chromatographic separation was achieved using an Acquity UPLC BEH C8 column (2.1 × 100 mm, 1.7 μm) with acetonitrile and 0.1% formic acid as mobile phase. The calibration curves of SA and NBP were linear in the concentration ranges of 0.25-100.00 and 0.12-48.00 ng/mL, respectively, with a correlation coefficient above 0.9992. All validation parameters, including intra- and inter-day precision, accuracy, matrix effect and stability, were within the acceptance limits of bioanalytical guidelines. The validated method was successfully applied to study the pharmacokinetics of SA and NBP in rat brain microdialysis after oral administration of Chuanxiong extracts. The results showed that both components penetrated the brain and reached maximum concentrations in the microdialysates of 72.31 and 9.93 ng/mL at 1.50 and 1.58 h, respectively.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142854094","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

Green Chromatographic Assay of Toxic Impurities of Cyproheptadine: In Silico Toxicity Profiling. 绿色色谱法检测赛庚啶的有毒杂质：In Silico 毒性分析。

IF 1.5 4区化学

Journal of chromatographic science Pub Date : 2025-01-09 DOI: 10.1093/chromsci/bmae004

Raghda A Emam, Aml A Emam

{"title":"Green Chromatographic Assay of Toxic Impurities of Cyproheptadine: In Silico Toxicity Profiling.","authors":"Raghda A Emam, Aml A Emam","doi":"10.1093/chromsci/bmae004","DOIUrl":"10.1093/chromsci/bmae004","url":null,"abstract":"Cyproheptadine (CYP) is an antihistaminic and anti-serotonin drug used to improve the clinical course of hospitalized patients severely affected by COVID-19 and requiring supplemental oxygen. Thin layer chromatography (TLC)-densitometry method was developed and validated for the estimation of CYP and its impurity, dibenzosuberone and its degradation product: 10, 11-dihydroxy-dibenzosuberone. The toxicity profiles of CYP impurity and degradation product were studied and the in silico data, using pre-ADMET software, proved their toxicity. A developing system of hexane: methanol: ethyl acetate: formic acid: triethylamine (8:1:1:0.05:0.1, by volume) was used with densitometric scanning at 245 nm. International Conference of Harmonization guidelines were obeyed for method validation. The proposed method was applied on CYP pharmaceutical formulation whose results showed no significant difference from results of the reported chromatographic method regarding accuracy and precision. Method's greenness was evaluated by analytical Eco scale, Green Analytical Procedure Index, and Analytical greenness approach tools. The developed method can be applied for safety check analysis of CYP containing formulations and detection and even quantification of its related toxic components in quality control laboratories at high sensitivity up to 20-fold than the reported chromatographic method.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139972015","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

Stability Indicating Method Development and Validation of Glycyrrhizin Using RP-HPLC-DAD: Application to Glycyrrhiza glabra Extract. 利用 RP-HPLC-DAD 开发和验证甘草苷的稳定性指示方法：在甘草提取物中的应用

IF 1.5 4区化学

Journal of chromatographic science Pub Date : 2025-01-09 DOI: 10.1093/chromsci/bmae022

Waibiangki Lyngdoh, Sandeep Jat, Pramod Kumar

{"title":"Stability Indicating Method Development and Validation of Glycyrrhizin Using RP-HPLC-DAD: Application to Glycyrrhiza glabra Extract.","authors":"Waibiangki Lyngdoh, Sandeep Jat, Pramod Kumar","doi":"10.1093/chromsci/bmae022","DOIUrl":"10.1093/chromsci/bmae022","url":null,"abstract":"Glycyrrhiza glabra is commonly known as licorice. Licorice is the major source of glycyrrhizin. There is no reported stability indicating method for glycyrrhizin in the literature so far. Therefore, it was proposed to develop a stability indicating method and validate the method for glycyrrhizin and its application in G. glabra root extract. Method validation parameters were performed as per the International Council for Harmonization guidelines. The chromatographic separation was achieved on a Zorbax Extended C-18 (250 × 4.6 mm, 5 μm) column. The separation achieved using the mobile phase consisted of 0.1% formic acid in water and acetonitrile in gradient elution. The flow rate was kept at 1 mL/min, and ultraviolet-visible spectroscopy detection was at 250 nm. The average retention time of glycyrrhizin was found to be 7.30 min. Stress degradation studies were performed and confirmed that only acidic degradation has shown a degradation profile of glycyrrhizin up to 40%. The percentage of glycyrrhizin was found to be 0.40% in the G. glabra extract. This may be further explored for commercial applications.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140849307","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

Chromatographic Separation and Quantification of Nine Nitrosamine Genotoxic Impurities in a Single Method in Nebivolol Tablet by Using Validated Ultra-Sensitive Liquid Chromatography: Mass Spectrometry Analytical Method. 内比洛尔片中9种亚硝胺类遗传毒性杂质的超灵敏液相色谱-质谱分离定量

IF 1.5 4区化学

Journal of chromatographic science Pub Date : 2025-01-09 DOI: 10.1093/chromsci/bmae061

Mehul Pathak, Dhara D Patel, Dalip Kumar, Avineesh Singh, Suresh Agrawal

{"title":"Chromatographic Separation and Quantification of Nine Nitrosamine Genotoxic Impurities in a Single Method in Nebivolol Tablet by Using Validated Ultra-Sensitive Liquid Chromatography: Mass Spectrometry Analytical Method.","authors":"Mehul Pathak, Dhara D Patel, Dalip Kumar, Avineesh Singh, Suresh Agrawal","doi":"10.1093/chromsci/bmae061","DOIUrl":"10.1093/chromsci/bmae061","url":null,"abstract":"N-nitrosamine impurities have been detected in a vast variety of drug substances and drug products, showing concern for regulatory aspects. To meet the regulatory requirement for the concerned impurity, a sensitive analytical method capable of quantifying these impurities at a lower level with accuracy and precision is required. This article focuses on the development and validation of an analytical method for the simultaneous detection of nine nitrosamine impurities in a single method for nebivolol drug product using liquid chromatography-mass spectrometry/mass spectrometry-atmospheric pressure chemical ionization (LC-MS/MS-APCI). The chromatographic separation was performed using the LC-MS column Allure BiPh C18 (250 × 4.6 mm), 5 μm employed a gradient mode elution program using 0.002 M Ammonium acetate buffer pH 4.5 as mobile phase A and methanol as mobile phase B. The method was challenged for accuracy, precision and linearity in accordance with International Council for Harmonization guidelines to ensure its suitability for the intended usage. The developed method was specific, accurate and linear with square of correlation coefficient (r2) found to be greater than 0.99 (0.9970-0.9992). The LOQ obtained in the range of 9.85-19.62 ppb for nine nitrosamines showed good sensitivity. The results demonstrated that method can be applied to quantify the nitrosamines in nebivolol drug products.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142894941","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

Using the AQbD Approach, Development and Validation of a Simple, Rapid Stability Indicating Chromatographic Method for Quantification of Related Impurities of Apixaban. 应用AQbD方法，建立一种简单、快速、稳定的指示色谱定量阿哌沙班相关杂质的方法并进行验证。

IF 1.5 4区化学

Journal of chromatographic science Pub Date : 2024-12-11 DOI: 10.1093/chromsci/bmad065

Jayasri Kilari, Pradeep Kumar Brahman

{"title":"Using the AQbD Approach, Development and Validation of a Simple, Rapid Stability Indicating Chromatographic Method for Quantification of Related Impurities of Apixaban.","authors":"Jayasri Kilari, Pradeep Kumar Brahman","doi":"10.1093/chromsci/bmad065","DOIUrl":"10.1093/chromsci/bmad065","url":null,"abstract":"Apixaban is a new oral anticoagulant that has been approved by the United States Food and Drug Administration for the prevention of stroke and other cardiovascular complications in people with non-valvular atrial fibrillation. Then, later, it was given the green light to treat deep venous thrombosis and pulmonary embolism. The biggest challenge in the development of pharmaceutical drugs is comprehending science- and risk-based techniques for developing and maintaining analytical procedures appropriate for evaluating the quality of drug substances and drug products. The improved technique provides a methodical strategy to acquire and improve understanding of an analytical method. The current study discusses the related substances method development for an apixaban drug substance employing a regulated authority refined and approved approach of the quality-by-design concept. For the quantification of impurities, and apixaban drug substance, a simple, quick and stability-indicating reverse-phase liquid chromatographic method was developed using a full factorial design. The separation between apixaban and its nine impurities was accomplished using an Zorbax Stable Bond Phenyl, 150 × 4.6 mm, 5 μm column. The mobile-phase components for gradient elution at a flow rate of 1.2 mL/min were chosen to be a mixture of water, acetonitrile, methanol and perchloric acid in various ratios with a total run time of 15 min. Chromatograms were extracted at 278 nm after a 5 μL solution injection. According to regulatory requirements, the developed method has been validated for its intended purpose.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":" ","pages":"978-989"},"PeriodicalIF":1.5,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10018713","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

Comparison of Plasma Concentration of Linezolid's Detection by FICA and LC-MS/MS. 通过 FICA 和 LC-MS/MS 检测利奈唑胺血浆浓度的比较

IF 1.5 4区化学

Journal of chromatographic science Pub Date : 2024-12-11 DOI: 10.1093/chromsci/bmae003

Jing Chen, Chenxia Zhu, Yangjin He, Hengbin Cao

{"title":"Comparison of Plasma Concentration of Linezolid's Detection by FICA and LC-MS/MS.","authors":"Jing Chen, Chenxia Zhu, Yangjin He, Hengbin Cao","doi":"10.1093/chromsci/bmae003","DOIUrl":"10.1093/chromsci/bmae003","url":null,"abstract":"Linezolid was the first totally synthetic oxazolidinone antibiotic that was approved for clinical use against Mycobacterium tuberculosis. Our study investigated the correlation and consistency of fluorescence immunochromatography assay (FICA) and high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) in measuring linezolid levels in the plasma. Plasma samples were collected from 80 to 100 tuberculosis patients. The samples were analyzed by FICA and LC-MS/MS, and linezolid levels measured by the two methods were compared by outlier test, correlation coefficient, Bland-Altman scatter plot, Deming regression analysis and bias evaluation. A total of 83 plasma samples were collected, all of which were non-outlier. The correlation coefficient of FICA and LC-MS/MS results was 0.9845. Deming regression analysis showed that the regression equation of FICA and LC-MS/MS was y = 0.2229 + 1.0076x. The medical decision levels of 2 and 7 μg/mL were taken into the regression equation, and the 95% CI of 2- and 7-μg/mL bias were both within the allowed error range. The findings indicated a strong correlation between the results obtained from FICA and LC-MS/MS were consistent showed good correlation, demonstrating their equivalence in measurement.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":" ","pages":"990-994"},"PeriodicalIF":1.5,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139746734","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

Nanoparticle Assisted Fabric Phase Sorptive Extraction for Azo Dye Determination in the Industrial Sewage. 纳米粒子辅助织物相吸附萃取法测定工业污水中的偶氮染料。

IF 1.5 4区化学

Journal of chromatographic science Pub Date : 2024-12-11 DOI: 10.1093/chromsci/bmae046

Nayereh Rahimian, Javad Feizy, Zarrin Es'haghi

{"title":"Nanoparticle Assisted Fabric Phase Sorptive Extraction for Azo Dye Determination in the Industrial Sewage.","authors":"Nayereh Rahimian, Javad Feizy, Zarrin Es'haghi","doi":"10.1093/chromsci/bmae046","DOIUrl":"10.1093/chromsci/bmae046","url":null,"abstract":"Currently, one of the significant environmental problems is the presence of azo dye materials in water sources. In this study, for the first time, a fast and sensitive sample preparation approach using nanoparticle-assisted fabric phase sorptive extraction (NFPSE) followed by high-performance liquid chromatography was examined to remove some azo dyes such as methyl red and sunset yellow from aqueous solutions. Primarily, the significance of several parameters affecting NFPSE, such as fabric type, the kind of sorbent, the number of contacts with sol-gel and the time of contact, was investigated. In addition, experiments were performed to determine the effect of different adsorption parameters, such as sample volume, adsorption time, adsorbent value, desorption time, ionic strength and pH. It was found that the calibration curve was linear within two ranges of concentrations (0.05-0.1 and 0.5-15 ng/L for methyl red; 0.05-0.5 and 0.5-15 ng/L for sunset yellow) with correlation coefficients better than 0.9683. The limit of detection was 0.014 ng/L for methyl red and 0.015 ng/L for sunset yellow. Repeatability Relative Standard Deviation (RSD) with three replicated experiments was 1.5-10% for methyl red and 2.5-5.8% for sunset yellow. Relative recovery percentages of 88-96% for methyl red and 62-92% for sunset yellow were obtained in the samples. Moreover, the results have shown that acceptable accuracy, precision and linearity make the \"fabric phase sorptive extraction\" a proper method for the determination of dyes from industrial sewage samples.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":" ","pages":"995-1006"},"PeriodicalIF":1.5,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141893545","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 Method for Determination of Cyclobenzaprine in the Different Matrixes by UHPLC-DAD: Application to Real Human Plasma and Pharmaceutical Formulations. UHPLC-DAD测定不同基质中环苯扎林的新方法：在人血浆及制剂中的应用。

IF 1.5 4区化学

Journal of chromatographic science Pub Date : 2024-12-11 DOI: 10.1093/chromsci/bmad052

Tugrul C Akman

{"title":"A Novel Method for Determination of Cyclobenzaprine in the Different Matrixes by UHPLC-DAD: Application to Real Human Plasma and Pharmaceutical Formulations.","authors":"Tugrul C Akman","doi":"10.1093/chromsci/bmad052","DOIUrl":"10.1093/chromsci/bmad052","url":null,"abstract":"This study presents a novel and efficient method for determining of cyclobenzaprine (CBP) in human plasma and tablets using simple liquid-liquid microextraction and ultra-high performance liquid chromatography-diode-array detector. The developed method was optimized and validated for selectivity, linearity, precision, accuracy, limit of detection (LOD) and limit of quantification (LOQ). The chromatographic separation was achieved using a C18 column with a mobile phase consisting of a mixture of deionized water containing 0.1% TFA and methanol (30:70, v:v) at a flow rate of 1.0 mL/min. The extraction process provided high-efficiency recovery of CBP with a small plasma volume (%94.3). The method showed good linearity within the concentration range of 0.005-10 μg/mL, with a correlation coefficient of 0.999. The LOD and LOQ values were found to be 0.0013 and 0.005 μg/mL, respectively. The intra- and inter-day %RSD were <8%, and %RE were ranged from -0.50 to 0.01%. The proposed method was successfully applied to the analysis of CBP in real human plasma samples and tablets, indicating its applicability in clinical and pharmaceutical research. In conclusion, the simple, low cost, high sensitivity and rapid nature of this method make it an attractive option for the quantification of CBP in human plasma and pharmaceutical dosage forms.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":" ","pages":"953-961"},"PeriodicalIF":1.5,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9890502","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

Implementation of White Analytical Chemistry-Assisted Analytical Quality by Design Approach to Green Liquid Chromatographic Method for Concomitant Analysis of Anti-Hypertensive Drugs in Human Plasma. 用设计方法实现白色分析化学辅助分析质量的绿色液相色谱法在人血浆中抗高血压药物伴随分析中的应用。

IF 1.5 4区化学

Journal of chromatographic science Pub Date : 2024-12-11 DOI: 10.1093/chromsci/bmad054

Pintu Prajapati, Abhinandan Shahi, Aneri Acharya, Veera Shakar Pulusu, Shailesh Shah

{"title":"Implementation of White Analytical Chemistry-Assisted Analytical Quality by Design Approach to Green Liquid Chromatographic Method for Concomitant Analysis of Anti-Hypertensive Drugs in Human Plasma.","authors":"Pintu Prajapati, Abhinandan Shahi, Aneri Acharya, Veera Shakar Pulusu, Shailesh Shah","doi":"10.1093/chromsci/bmad054","DOIUrl":"10.1093/chromsci/bmad054","url":null,"abstract":"According to current concepts of white analytical chemistry (WAC), the use of organic solvents those are teratogenic and carcinogenic must be avoided for the protection of the environment and of the analysts. This led to the development and validation of the WAC-assisted green liquid chromatographic technique (reverse-phase high-pressure liquid chromatography (RP-HPLC)) for the simultaneous analysis of anti-hypertensive drugs (azilsartan medoxomil, chlorthalidone and cilnidipine) in human plasma and their fixed-dose combinations. The analytical quality by design approach was used in conjunction with the design of experiments and chemometrics concepts to develop the method. To develop the green RP-HPLC method, critical method variables (CMVs) and critical analytical attributes were identified using the multivariate analytical tools principal component analysis and partial least square regression. Using the Box-Behnken design, the design of experiments was used for CMV optimization and response surface analysis. It was possible to explore the analytical design space for the life cycle management of the RP-HPLC method. The developed method was found to be validated following International Council for Harmonization Q2 (R1) and M10 requirements. Using the red, green and blue paradigm, the existing and proposed chromatographic methods were evaluated for their validation efficacy, greenness profile and cost-effectiveness.","PeriodicalId":15430,"journal":{"name":"Journal of chromatographic science","volume":" ","pages":"938-952"},"PeriodicalIF":1.5,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10268978","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