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Journal of Pharmaceutical and Biomedical Analysis

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https://www.readbyqxmd.com/read/28645021/development-a-validated-highly-sensitive-lc-ms-ms-method-for-simultaneous-quantification-of-ledipasvir-sofosbuvir-and-its-major-metabolite-gs-331007-in-human-plasma-application-to-a-human-pharmacokinetic-study
#1
Ola M Abdallah, Ahmed M Abdel-Megied, Amira S Gouda
A highly sensitive and rapid LC-MS/MS method was developed, fully optimized and validated for the simultaneous determination of Ledipasvir (LED) and Sofosbuvir (SOF) in the presence of its major metabolite GS-331007 in human plasma using Daclatasvir as internal standard (IS). The extraction of analytes and IS from plasma was performed using liquid-liquid extraction with ethyl acetate. The chromatographic separation of these prepared samples was achieved on Xterra MS C8 column (4.6×50mm,5μm) using gradient elution with a mobile phase of ammonium formate buffer (pH 3...
June 20, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28645015/mid-infrared-and-near-infrared-spectroscopy-for-rapid-detection-of-gardeniae-fructus-by-a-liquid-liquid-extraction-process
#2
Lingyan Tao, Zhonglin Lin, Jiashan Chen, Yongjiang Wu, Xuesong Liu
Gardeniae Fructus is widely used in the pharmaceutical industry, and many studies have confirmed its medical and economic value. In this study, samples collected from different liquid-liquid extraction batches of Gardeniae Fructus were detected by mid-infrared (MIR) and near-infrared (NIR) spectroscopy. Seven analytes, neochlorogenic acid (5-CQA), cryptochlorogenic acid (4-CQA), chlorogenic acid (3-CQA), geniposidic acid (GEA), deacetyl-asperulosidic acid methyl ester (DAAME), genipin-gentiobioside (GGB), and gardenoside (GA), were chosen as quality property indexes of Gardeniae Fructus...
June 16, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28646659/analysis-of-recombinant-monoclonal-antibodies-in-hydrophilic-interaction-chromatography-a-generic-method-development-approach
#3
Balázs Bobály, Valentina D'Atri, Alain Beck, Davy Guillarme, Szabolcs Fekete
Hydrophilic interaction liquid chromatography (HILIC) is a well-established technique for the separation and analysis of small polar compounds. A recently introduced widepore stationary phase expanded HILIC applications to larger molecules, such as therapeutic proteins. In this paper, we present some generic HILIC conditions adapted for a wide range of FDA and EMA approved recombinant monoclonal antibody (mAb) species and for an antibody-drug conjugate (ADC). Seven approved mAbs possessing various isoelectric point (pI) and hydrophobicity as well as a cysteine conjugated ADC were used in this study...
June 15, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28646658/investigation-and-structural-elucidation-of-a-new-impurity-in-bulk-drug-of-cilostazol-by-lc-ms-ms-ft-ir-and-nmr
#4
Zhaoxia Hu, Sanguo Gao, Jue Gao
A new impurity was detected in bulk cilostazol (CIL) crude during routine analysis. The impurity (∼4%, the specification for unknown impurity in crude is not more than 0.20%) has a relative retention time of 1.46. Based on MS, NMR and IR spectral data, the impurity was identified as 6,6'-bis(4-(1-cyclohexyl-1H-tetrazol-5-yl) butoxy)-3,3',4,4'-tetrahydro-[7,7'-biquinoline]-2,2'(1H,1'H)-dione(CIL-dimer). The precursor of CIL-dimer is an oxidative product of starting material 6-Hydroxy-3,4-dyhydro-1H-quinolin-2-one(6-HQ), CIL-dimer was formed in the following reaction with 5-(3-Chloro-propyl)-1-cyclohexyl-1H-tetrazol(CHCBT)...
June 15, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28645016/quantitative-analysis-of-a-biopharmaceutical-protein-in-cell-culture-samples-using-automated-capillary-electrophoresis-ce-western-blot
#5
Dong Xu, Kentaro Marchionni, Yunli Hu, Wei Zhang, Zoran Sosic
An effective control strategy is critical to ensure the safety, purity and potency of biopharmaceuticals. Appropriate analytical tools are needed to realize such goals by providing information on product quality at an early stage to help understanding and control of the manufacturing process. In this work, a fully automated, multi-capillary instrument is utilized for size-based separation and western blot analysis to provide an early readout on product quality in order to enable a more consistent manufacturing process...
June 15, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28633061/1-4-anthraquinone-a-new-useful-pre-column-reagent-for-the-determination-of-n-acetylcysteine-and-captopril-in-pharmaceuticals-by-high-performance-liquid-chromatography
#6
Rita Gatti, Rita Morigi
1,4-Anthraquinone (ANQ) is proposed as a novel pre-column reagent for high performance liquid chromatography (HPLC) determination of N-acetylcysteine (NAC) and captopril (CAP) in pharmaceutical formulations. The derivatization reactions were carried out at room temperature: NAC at pH 8 for 1min, while CAP at pH 7.5 for 20min. Both reactions reached completeness at a reagent to thiol molar ratio of about 2.5. The synthesised derivatives were characterized by (1)H NMR and IR. The chromatographic separations were performed on a C18 Phenomenex Synergi Fusion 4μm (250mm×4...
June 15, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28628861/enhancement-in-recovery-of-drugs-with-high-protein-binding-efficiency-from-human-plasma-using-magnetic-nanoparticles
#7
Aniruddha Bhati, Rucha P Desai, C N Ramchand
In this paper, we propose an alternate method for bioanalytical extraction of drugs from human plasma samples using bare magnetic nanoparticles. The magnetic nanoparticles (MNPs) were used for deproteination of biological samples that further assist in extraction of plasma bound drugs for bioanalytical studies. The method uses basic solvents (ethanol, methanol, etc.) rather than the expensive and toxic solvents. The MNPs provide several advantages like avoiding the use of centrifuge machine, and making extraction time effective...
June 13, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28628863/simultaneous-quantification-of-endothelin-receptor-antagonists-and-phosphodiesterase-5-inhibitors-currently-used-in-pulmonary-arterial-hypertension
#8
Yeliz Enderle, Lukas Witt, Heinrike Wilkens, Ekkehard Grünig, Walter E Haefeli, Jürgen Burhenne
Combination treatment with endothelin receptor antagonists (ERA) and phosphodiesterase 5 inhibitors (PDE5I) improved efficacy of pulmonary arterial hypertension (PAH) therapy. However, drug-drug interactions, variable exposure, non-adherence can influence plasma levels. For these reasons, drug quantification may be advantageous particularly in patients with poor treatment responses. We developed, validated, and applied an assay for the simultaneous quantification of ambrisentan, bosentan, macitentan, sildenafil, and tadalafil as well as their main (and partly active) metabolites in human plasma...
June 10, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28605680/surrogate-cd16-expressing-effector-cell-lines-for-determining-the-bioactivity-of-therapeutic-monoclonal-antibodies
#9
Shalom A Gurjar, Jeremy P Derrick, Rebecca J Dearman, Robin Thorpe, Simon Hufton, Ian Kimber, Meenu Wadhwa
Traditional antibody dependent cellular cytotoxicity (ADCC) assays use donor derived natural killer (NK) or peripheral blood mononuclear cells, but donor genetic variability and the technically challenging nature of the assay means that alternative in vitro assay formats are required. We explored the utility of two reporter gene cell lines, the J2 and J9, as surrogate effector cells for ADCC assays. Both express the ADCC relevant Fcγ receptor CD16, crosslinking of which leads to firefly luciferase expression...
June 9, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28618342/monitoring-breast-cancer-treatment-using-a-fourier-transform-infrared-spectroscopy-based-computational-model
#10
J Depciuch, E Kaznowska, S Golowski, A Koziorowska, I Zawlik, M Cholewa, K Szmuc, J Cebulski
Breast cancer affects one in four women, therefore, the search for new diagnostic technologies and therapeutic approaches is of critical importance. This involves the development of diagnostic tools to facilitate the detection of cancer cells, which is useful for assessing the efficacy of cancer therapies. One of the major challenges for chemotherapy is the lack of tools to monitor efficacy during the course of treatment. Vibrational spectroscopy appears to be a promising tool for such a purpose, as it yields Fourier transformation infrared (FTIR) spectra which can be used to provide information on the chemical composition of the tissue...
June 8, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28618340/fast-and-efficient-zirconia-based-reversed-phase-chromatography-for-selective-determination-of-triptans-in-rat-plasma
#11
Sameh Ahmed, Noha N Atia
Selective and fast chromatographic method was essential for the determination of triptans, selective serotonin receptor (5-HT1) agonists, in biological specimens. However, selective chromatographic separation of these highly basic drugs is a challenging problem on silica-based stationary phases. Zirconia-based stationary phases have been introduced as an efficient alternative for silica-based columns offering unique stability, selectivity, and retention ability for various classes of drugs. Herein, a new selective, fast and reproducible high performance liquid chromatographic method (HPLC) was developed and validated for the determination of four triptans in plasma samples namely; Sumatriptan (SMT), Zolmitriptan (ZLT), Eletriptan (ELT) and Rizatriptan (RZT)...
June 7, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28605681/a-vote-for-robustness-monitoring-serum-enzyme-activity-by-thin-layer-chromatography-of-dabsylated-bradykinin-products
#12
Malte Bayer, Simone König
High-end analytical methods provide excellent data but may lack the robustness required in large analytical studies. In particular complex chemical matrices may cause difficulties and increase the need for extensive sample preparation. For screening of patients we thus developed a low-tech assay to monitor bradykinin degradation by serum proteases. The bradykinin concentration mirrors the activity of angiotensin-converting enzyme (ACE). Dabsylated bradykinin (DBK) and its labeled fragments DBK1-8 and DBK1-5 were visualized by thin-layer chromatography using only 3μL of serum...
June 6, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28641906/pharmaceutical-and-biomedical-analysis-of-cannabinoids-a-critical-review
#13
REVIEW
Cinzia Citti, Daniela Braghiroli, Maria Angela Vandelli, Giuseppe Cannazza
Cannabis products have recently regained much attention due to the high pharmacological potential of their cannabinoid content. In this review, the most widely used sample preparation strategies for the extraction of cannabinoids are described for the specific application to either plant materials or biological matrices. Several analytical techniques are described pointing out their respective advantages and drawbacks. In particular, chromatographic methods, such as TLC, GC and HPLC, are discussed and compared in terms of selectivity and sensitivity...
June 4, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28609672/development-of-a-new-extraction-technique-and-hplc-method-for-the-analysis-of-non-psychoactive-cannabinoids-in-fibre-type-cannabis-sativa-l-hemp
#14
Virginia Brighenti, Federica Pellati, Marleen Steinbach, Davide Maran, Stefania Benvenuti
The present work was aimed at the development and validation of a new, efficient and reliable technique for the analysis of the main non-psychoactive cannabinoids in fibre-type Cannabis sativa L. (hemp) inflorescences belonging to different varieties. This study was designed to identify samples with a high content of bioactive compounds, with a view to underscoring the importance of quality control in derived products as well. Different extraction methods, including dynamic maceration (DM), ultrasound-assisted extraction (UAE), microwave-assisted extraction (MAE) and supercritical-fluid extraction (SFE) were applied and compared in order to obtain a high yield of the target analytes from hemp...
June 4, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28641198/combined-computational-experimental-approach-to-predict-blood-brain-barrier-bbb-permeation-based-on-green-salting-out-thin-layer-chromatography-supported-by-simple-molecular-descriptors
#15
Krzesimir Ciura, Mariusz Belka, Piotr Kawczak, Tomasz Bączek, Michał J Markuszewski, Joanna Nowakowska
The objective of this paper is to build QSRR/QSAR model for predicting the blood-brain barrier (BBB) permeability. The obtained models are based on salting-out thin layer chromatography (SOTLC) constants and calculated molecular descriptors. Among chromatographic methods SOTLC was chosen, since the mobile phases are free of organic solvent. As consequences, there are less toxic, and have lower environmental impact compared to classical reserved phases liquid chromatography (RPLC). During the study three stationary phase silica gel, cellulose plates and neutral aluminum oxide were examined...
June 3, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28618341/analytical-profiling-of-selected-antioxidants-and-total-antioxidant-capacity-of-goji-lycium-spp-berries
#16
Michele Protti, Isacco Gualandi, Roberto Mandrioli, Sergio Zappoli, Domenica Tonelli, Laura Mercolini
Goji berries and derived products represent a relevant source of micronutrients, most of which are natural antioxidants and contribute to the high nutritional quality of these fruits. Three brands of dried goji berries have been analysed by a multidisciplinary approach to get an insight into both their content of selected antioxidants and their antioxidant capacity (AC). The former goal has been achieved by developing a liquid chromatographic method coupled to mass spectrometry and combined to a fast solid phase extraction...
June 3, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28609671/salting-out-assisted-liquid-liquid-extraction-combined-with-gas-chromatography-mass-spectrometry-for-the-determination-of-pyrethroid-insecticides-in-high-salinity-and-biological-samples
#17
Zongliang Niu, Chunwei Yu, Xiaowen He, Jun Zhang, Yingying Wen
A salting-out assisted liquid-liquid extraction (SALLE) combined with gas chromatography-mass spectrometry (GC-MS) method was developed for the determination of four pyrethroid insecticides (PYRs) in high salinity and biological samples. Several parameters including sample pH, salting-out solution volume and salting-out solution pH influencing the extraction efficiency were systematically investigated with the aid of orthogonal design. The optimal extraction conditions of SALLE were: 4mL of salting-out solution with pH=4 and the sample pH=3...
June 3, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28605682/a-uhplc-method-for-the-rapid-separation-and-quantification-of-anthocyanins-in-acai-berry-and-dry-blueberry-extracts
#18
Jakub Fibigr, Dalibor Šatínský, Petr Solich
The presented work describes the development and validation of a rapid UHPLC-UV method using a core-shell particle column with a pentafluorophenyl stationary phase for the separation and quantitative analysis of the six anthocyanins in acai berry and dry blueberry extracts. The anthocyanins (cyanidin-3-glucoside, cyanidin-3-rutenoside, delphinidin-3-galactoside, delphinidin-3-glucoside, delphinidin-3-rutenoside, and peonidin-3-glucoside) were separated and analyzed in 5min. The chromatographic separation was performed on a Kinetex PFP (150×2...
June 3, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28605679/a-re-investigation-of-the-phytochemical-composition-of-the-edible-herb-amaranthus-retroflexus-l
#19
Serena Fiorito, Francesco Epifano, Roberta Palmisano, Salvatore Genovese, Vito Alessandro Taddeo
In this paper the presence of selected prenylated and unprenylated phenylpropanoids of nutraceutical value, namely umbelliferone, apigenin, 4'-geranyloxyferulic acid, 7-isopentenyloxycoumarin, auraptene, and umbelliprenin have been determined in all parts of the edible herb Amaranthus retroflexus extracted with different methodologies. Roots were seen to contain the widest variety of unprenylated and prenylated phenylpropanoids both in terms of number of secondary metabolites and their quantitites. Findings described in the present study underline how A...
June 3, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28601766/trace-level-determination-of-5-hydroxytryptamine-and-its-related-indoles-in-amniotic-fluid-by-gas-chromatography-mass-spectrometry
#20
Hongmei Shi, Bo Wang, Lingmei Niu, Mengsi Cao, Weijun Kang, Kaoqi Lian, Pingping Zhang
5-hydroxytryptamine (5-HT) and its derivatives are endogenously active substances involved in multiple physiological and pathological processes. A novel method of detetermining 5-hydroxyindole ethanol (5-HTOL), 5-hydroxyindole acetic acid (5-HIAA), 5-hydroxytryptophan (5-HTP) and 5-HT in amniotic fluid by gas chromatography-mass spectrometry (GC-MS) was established based on a modified method of derivatization by silanization, in combination with solid-phase extraction pretreatment. Good linearity was achieved in the tested calibration range...
June 3, 2017: Journal of Pharmaceutical and Biomedical Analysis
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