Journal of Chemical Metrology最新文献

A new HPLC-UV method for the simultaneous measurements of α-escin and β-escin in creams containing Aesculus hippocastanum L. extract 高效液相色谱-紫外同时测定含海马提取物的膏霜中α-escin和β-escin含量的新方法

IF 1.3

Journal of Chemical Metrology Pub Date : 2023-12-17 DOI: 10.25135/jcm.101.2310.2985

Burhan Ceylan

引用次数: 0

Gradient reversed-phase HPLC method for the quantitation of azelnidipine and chlorthalidone in a fixed-dose synthetic mixture 梯度反相高效液相色谱法定量测定固定剂量合成混合物中的阿折地平和氯沙酮

IF 1.3

Journal of Chemical Metrology Pub Date : 2023-12-17 DOI: 10.25135/jcm.100.2311.2977

R. Kotadiya, Juhi Raimalani

引用次数: 0

Quantification of main secondary metabolites of Satureja icarica P.H. Davis (Lamiaceae) by LC-HRMS and evaluation of antioxidant capacities 利用 LC-HRMS 对 Satureja icarica P.H. Davis（拉米亚科植物）的主要次生代谢物进行定量和抗氧化能力评估

IF 1.3

Journal of Chemical Metrology Pub Date : 2023-12-14 DOI: 10.25135/jcm.2311.2956

A. Gören, Betül Kiraz Kinoğlu, T. Dirmenci, Saleh H. Alwasel, I. Gülçin

引用次数: 0

An effective HPLC method for evaluation of process related impurities of Letermovir and LC-MS/MS characterization of forced degradation compounds 评估来替米韦工艺相关杂质的高效液相色谱法和强制降解化合物的 LC-MS/MS 表征

IF 1.3

Journal of Chemical Metrology Pub Date : 2023-12-14 DOI: 10.25135/jcm.98.2311.2975

Rajesh Varma Bhupatiraju, B. S. Kumar, Pavani Peddi, V. Tangeti

引用次数: 0

A validated RP-HPLC assay method for Tofacitinib in pharmaceutical drug products 药物产品中托法替尼的 RP-HPLC 有效测定方法

IF 1.3

Journal of Chemical Metrology Pub Date : 2023-11-30 DOI: 10.25135/jcm.97.2307.2859

O. Pınarbaşlı, Tolga Özbay, G. Gurbetoğlu, Nagehan Sarraçoğlu, Asuman Aybey Doganay

{"title":"A validated RP-HPLC assay method for Tofacitinib in pharmaceutical drug products","authors":"O. Pınarbaşlı, Tolga Özbay, G. Gurbetoğlu, Nagehan Sarraçoğlu, Asuman Aybey Doganay","doi":"10.25135/jcm.97.2307.2859","DOIUrl":"https://doi.org/10.25135/jcm.97.2307.2859","url":null,"abstract":": This study aimed to establish and validate a reliable RP-HPLC assay method for the quantification of tofacitinib (TFC), a janus kinase (JAK) inhibitor, in pharmaceutical formulations. The newly developed method exhibits simplicity, specificity, precision, and sensitivity. Experimental procedures utilized a Shimadzu Prominence 20A HPLC system equipped with a Inertsil ODS 3V C18 column (5µm particle size, 4.6 X 250 mm dimensions). The mobile phase, consisting of 0.05M ammonium acetate buffer at pH 5.0 and acetonitrile (65:35 v/v) in isocratic mode with a flow rate of 1.0 mL/min, facilitated accurate detection of the Tofacitinib peak at 230 nm wavelength. Comprehensive validation, including assessments of linearity, accuracy, precision, and robustness, was conducted in accordance with ICH requirements. The results demonstrated satisfaction, with a retention time (t R ) of approximately 5.3 minutes. The imperative need for a swift and efficient RP-HPLC method for analyzing TFC led to the successful development and validation of this technique. Consequently, the RP-HPLC method has undergone thorough validation, establishing it as a user-friendly and trustworthy means for Tofacitinib analysis.","PeriodicalId":15343,"journal":{"name":"Journal of Chemical Metrology","volume":" 35","pages":""},"PeriodicalIF":1.3,"publicationDate":"2023-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139197705","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparison between top-down and bottom-up approaches in the estimation of measurement uncertainty in Bisphenol A analysis by HPLC-FLD HPLC-FLD测定双酚A不确定度的自上而下与自下而上方法比较

Journal of Chemical Metrology Pub Date : 2023-11-09 DOI: 10.25135/jcm.95.2308.2862

Mustafa Özyürek, Mehmet Kılınçer

{"title":"Comparison between top-down and bottom-up approaches in the estimation of measurement uncertainty in Bisphenol A analysis by HPLC-FLD","authors":"Mustafa Özyürek, Mehmet Kılınçer","doi":"10.25135/jcm.95.2308.2862","DOIUrl":"https://doi.org/10.25135/jcm.95.2308.2862","url":null,"abstract":": Measurement uncertainty is a metrological concept that characterizes distributions/variations that can make the measurement results logical and is linked to the result of the measurement. The measurement uncertainty of the method was estimated using two basic approaches (top-down and bottom-up approach). The top-down approach covers in-house validation data (trueness, repeatability and intra-lab reproducibility), while the bottom-up approach involves individual contributions to all uncertainty at each stage of the analysis/process. We estimated measurement uncertainty of BPA analysis by HPLC-FLD test according to JCGM GUM and EURACHEM-CITAC guidelines. The relative expanded uncertainties at the BPA concentration by the bottom-up approach and top-down approaches were ±3.2% and ±4.8% respectively (95% confidence interval, k=2). Thus, although it is seen that the results of the two approaches are different in chromatographic BPA analysis, it is concluded that the measurement uncertainty related to BPA analysis, especially in food analysis laboratories, can be determined by a simpler top-down approach.","PeriodicalId":15343,"journal":{"name":"Journal of Chemical Metrology","volume":" 16","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135286422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Reversed phase-HPLC-PDA method for quantification of Desidustat 反相高效液相色谱- pda法定量灭司他

Journal of Chemical Metrology Pub Date : 2023-11-09 DOI: 10.25135/jcm.95.2307.2839

Hetaben Kachhiya, Rutvik Pandya, Krunal Solanki, Jinal Tandel, Usmangani Chhalotiya, Dimal Shah

引用次数: 0

Development and validation of RP-HPLC method for estimation of Torsemide and Spironolactone in bulk and pharmaceutical dosage forms: a quality by design approach 托尔塞米和螺内酯散装和药用剂型的RP-HPLC方法的开发和验证:质量设计方法

Journal of Chemical Metrology Pub Date : 2023-11-05 DOI: 10.25135/jcm.94.2304.2769

Tejas Patel, Shantilal Padhiyar, Vipul Prajapati, Harsh Kela, Vashisth Bhavsar, Jagat Upadhyay

引用次数: 0

Simultaneous determiantion of aripiprazole and escitalopram oxalate by HPLC HPLC法同时测定阿立哌唑和草酸艾司西酞普兰的含量

Journal of Chemical Metrology Pub Date : 2023-10-10 DOI: 10.25135/jcm.92.2307.2830

Divyakumari Kiransinh Solanki, Sagarkumar P. Patel, Jasmina Surati, Ashok Akabari, Ketan Shah, Dipansu Sahu, Sagarkumar Patel

{"title":"Simultaneous determiantion of aripiprazole and escitalopram oxalate by HPLC","authors":"Divyakumari Kiransinh Solanki, Sagarkumar P. Patel, Jasmina Surati, Ashok Akabari, Ketan Shah, Dipansu Sahu, Sagarkumar Patel","doi":"10.25135/jcm.92.2307.2830","DOIUrl":"https://doi.org/10.25135/jcm.92.2307.2830","url":null,"abstract":": Simple, accurate, precise, and sensitive reverse-phase high-performance liquid chromatographic (HPLC) method was developed for the simultaneous measurement of ARI and ESC in pharmaceutical products by using a C18 column with dimensions of 250 mm x 4.6 mm and a particle size of 5 μm. The mobile phase consisted of a mixture of acetonitrile, methanol, and water in the ratio of 80:05:15 v/v/v. Orthophosphoric acid was added to adjust the pH to 7.00 ± 0.1. The detection wavelength used for measuring the absorbance of the components was 246 nm, and the Mobile Phase flow rate was set at 1.0 mL/min. The retention times of ARI and ESC were 5.63 and 3.65 minutes, respectively. The ARI and ESC correlation coefficients (R 2 -values) were observed at 0.9995 and 0.9997, respectively, demonstrating a robust linear relationship between the analyte concentration and the observed absorbance. The linearity range for ARI was 20 to 120 μg/mL, while ESC was 60 to 360 μg/mL. The recovery percentages for ARI and ESC ranged from 99.43% to 100.65% and 99.58% to 100.15%, respectively. Additionally, all parameter uncertainty levels were below 2. The method was validated following ICH guideline Q2 (R1). The analytical method validated will be successfully applied to the pharmaceutical dosage form.","PeriodicalId":15343,"journal":{"name":"Journal of Chemical Metrology","volume":"3 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136294936","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

In-vitro release study of Racecadotril from granule sachets: influence of Brij-35 消旋卡多曲颗粒剂体外释放研究:Brij-35的影响

IF 1.3

Journal of Chemical Metrology Pub Date : 2023-09-04 DOI: 10.25135/jcm.91.2307.2837

Cem Çalışkan, Onur Çakır, Muge Guleli, Yavuz Selim Toksöz, H. I. Uğraş

{"title":"In-vitro release study of Racecadotril from granule sachets: influence of Brij-35","authors":"Cem Çalışkan, Onur Çakır, Muge Guleli, Yavuz Selim Toksöz, H. I. Uğraş","doi":"10.25135/jcm.91.2307.2837","DOIUrl":"https://doi.org/10.25135/jcm.91.2307.2837","url":null,"abstract":": For sachet drug forms containing Racecadotril, which are freely soluble in methanol and methylene chloride but practically insoluble in water, used as an anti-diarrhea, suitable dissolution media meeting the parameters requested by the authorities are not available in the literature and monographs. For this reason, a suitable dissolution medium was determined in accordance with the guidelines and the dissolution profiles of reference product and samples used in the study. The profiles were compared, and the method was validated. In order to determine the most suitable medium for the release of drug product, in vitro dissolution tests were performed in media prepared by different buffers similar to the pH of the gastrointestinal tract (GIT) and media containing Brij 35. In this context, the effects of buffers, pH, and different surfactants were evaluated, and it was found that Polyoxyethylene 23 lauryl ether (Brij-35), a nonionic surfactant, increased the solubility. The results were obtained with RP-HPLC method using Kromasil C18 150 mm x 4.6 mm, 5 µm column with a flow rate of 1.5 ml/min at 210 nm wavelength in 7 minutes for Racecadotril, which dissolves at least 60% of the label value after 45 minutes after the dissolution studies performed with a type II apparatus at 37°C. A suitable dissolution medium was found for sachet drug forms containing Racecadotril, and the analytical method was validated in accordance with the ICH Q2 (R1) guideline. In addition, the difference factor (f 1 ) and similarity factor (f 2 ) were calculated to compare the dissolution profiles of the reference product and samples in this determined dissolution medium.","PeriodicalId":15343,"journal":{"name":"Journal of Chemical Metrology","volume":" ","pages":""},"PeriodicalIF":1.3,"publicationDate":"2023-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48408583","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0