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Journal of Pharmaceutical and Biomedical Analysis

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https://www.readbyqxmd.com/read/28531833/development-of-an-in-vivo-relevant-drug-product-performance-method-for-an-amorphous-solid-dispersion
#1
Brian W Pack, Yelizaveta Babayan, Mark A Schrad, Paul A Stroud, David C Sperry, Kevin C White, Aktham Aburub
The purpose of this work was to develop a meaningful in vitro dissolution method for evacetrapib spray-dried dispersion (SDD) tablets that is discriminating for crystalline drug substance (DS) content. Justification of the method conditions included evaluation of dissolution media, rotation speed, surfactant selection and level of surfactant to achieve sink conditions. Discrimination was illustrated by testing SDD tablets spiked with 10%, 20%, and 30% crystalline DS. The results demonstrated a 13%, 22% and 32% drop in the dissolution end point, respectively, as compared to unspiked SDD tablets...
May 17, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28538205/a-rapid-microextraction-by-packed-sorbent-liquid-chromatography-tandem-mass-spectrometry-method-for-the-determination-of-dexamethasone-disodium-phosphate-and-dexamethasone-in-aqueous-humor-of-patients-with-uveitis
#2
Federica Bianchi, Monica Mattarozzi, Nicolò Riboni, Paolo Mora, Stefano A Gandolfi, Maria Careri
A new method based on microextraction by packed sorbent (MEPS) coupled with liquid chromatography-tandem mass spectrometry (LC-MS/MS) was developed and validated for the determination of dexamethasone and dexamethasone disodium phosphate in human aqueous humor. A central composite design was applied to investigate the effects of both loading and eluting cycles in the MEPS procedure; subsequently the multicriteria method of the desirability functions allowed to find the best conditions for the simultaneous extraction of both the analytes...
May 15, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28531834/bioelectrical-impedimetric-sensor-for-single-cell-analysis-based-on-nanoroughened-quartz-substrate-suitable-for-cancer-therapeutic-purposes
#3
Milad Gharooni, Mohammad Abdolahad
Single cells analysis has been interested in recent decade. Apart from scientific benefits to achieve new biological phenomena in cell study, many diagnostic and therapeutic protocols in non-communicable diseases were introduced by single cell analysis. Moreover, non-invasive methods to maintain the investigated cell for time dependent monitoring has been widely studied because of its importance in some crucial cases such as drug resistance in cancer. Bioelectrical monitoring is one of such methods Although the procedures reported based on electrical probing might not induce cell disruption, indirect connection between recording electrodes and cell membrane (mostly in microfluidic approaches) reduced the quality of response and limited the precision of the results...
May 15, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28538203/uhplc-ms-ms-method-with-sample-dilution-to-test-therapeutic-adherence-through-quantification-of-ten-antihypertensive-drugs-in-urine-samples
#4
Amedeo De Nicolò, Valeria Avataneo, Franco Rabbia, Mauro Sciandra, Francesco Tosello, Jessica Cusato, Elisa Perlo, Paolo Mulatero, Franco Veglio, Giovanni Di Perri, Antonio D'Avolio
Nowadays, hypertension represents an important health problem, particularly in developed countries. In some cases the standard therapeutic approaches are not able to reestablish the normal blood pressure values: this condition is called "resistant hypertension". However, a fraction of cases of resistant hypertension are actually due to poor adherence to the prescribed therapy. Therapeutic Drug Monitoring could represent a direct and useful tool to correctly identify non-compliant patients. Nevertheless, high throughput methods for the simultaneous monitoring of a wide panel of drugs in the same analysis are lacking and, furthermore, there is not a generally acknowledged "standard" matrix for this test (plasma or urine)...
May 13, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28535451/a-novel-carbohydrate-labeling-method-utilizing-transfer-hydrogenation-mediated-reductive-amination
#5
Zsuzsanna Kovács, Gábor Papp, Henrietta Horváth, Ferenc Joó, András Guttman
One of the most frequently used high-resolution glycan analysis methods in the biopharmaceutical and biomedical fields is capillary electrophoresis with laser-induced fluorescence (CE-LIF) detection. Glycans are usually labeled by reductive amination with a charged fluorophore containing a primary amine, which reacts with the aldehyde group at the reducing end of the glycan structures. In this reaction, first a Schiff base is formed that is reduced to form a stable conjugate by a hydrogenation reagent, such as sodium cyanoborohydride...
May 13, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28531832/fighting-falsified-medicines-the-analytical-approach
#6
REVIEW
Hervé Rebiere, Pauline Guinot, Denis Chauvey, Charlotte Brenier
Given the harm to human health, the fight against falsified medicines has become a priority issue that involves numerous actors. Analytical laboratories contribute by performing analyses to chemically characterise falsified samples and assess their hazards for patients. A wide range of techniques can be used to obtain individual information on the organic and inorganic composition, the presence of an active substance or impurities, or the crystalline arrangement of the formulation's compound. After a presentation of these individual techniques, this review puts forward a methodology to combine them...
May 13, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28531831/workflow-methodology-for-rat-brain-metabolome-exploration-using-nmr-lc-ms-and-gc-ms-analytical-platforms
#7
Binta Diémé, Antoine Lefèvre, Lydie Nadal-Desbarats, Laurent Galineau, Blandine Madji Hounoum, Frédéric Montigny, Hélène Blasco, Christian R Andres, Patrick Emond, Sylvie Mavel
We developed a multi-platform approach for the metabolome exploration of rat brain tissue, using liquid chromatography coupled with mass spectrometry (LC-MS), nuclear magnetic resonance spectroscopy (NMR) and gas-chromatography coupled with mass spectrometry (GC-MS). The critical steps for metabolite exploration of cerebral tissues are tissue lysis and metabolites extraction. We first evaluated the impact of freeze-drying compared to wet tissue metabolites extraction using NMR and LC-MS with a reversed phase liquid chromatography...
May 13, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28535452/highly-sensitive-uhplc-ms-ms-method-for-the-simultaneous-estimation-of-propafenone-and-its-metabolites-5-hydroxypropafenone-and-n-depropylpropafenone-on-human-dried-blood-spots-technique-and-application-to-a-pharmacokinetic-study
#8
Adinarayana Andy, Raja Reddy Kallem, Ramesh Mullangi, Divya Andy, J V L N Seshagiri Rao
A highly sensitive, rapid and selective UHPLC-MS/MS method has been developed and validated for quantification of the propafenone (PF), 5-hydroxypropafenone (5-OHPF) and N-depropylpropafenone (N-DPF) on human dried blood spot (DBS). The assay procedure involves a solid-liquid extraction of PF, 5-OHPF and N-DPF and amlodipine (internal standard, I.S.) from dried human DBS cards using water and acetonitrile. The chromatographic resolution was achieved on a BEH C18 column using a gradient mobile phase consisting of 0...
May 11, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28528145/uv-induced-electron-transfer-between-triethylamine-and-5-bromo-2-deoxyuridine-a-puzzle-concerning-the-photochemical-debromination-of-labeled-dna
#9
Paweł Wityk, Magdalena Zdrowowicz, Justyna Wiczk, Janusz Rak
5-Bromo-2'-deoxyuridine (BrdU) photosensitizes DNA to strand break formation. However, this type of photodamage is completely quenched by the presence of triethylamine (TEA) which originates from RP-HPLC purification commonly employed by oligonucleotide providers. While the presence of TEA in oligonucleotide samples does not interfere with PCR or other molecular biology applications, the mechanism of photochemical reaction proceeding in the labeled DNA is dramatically changed due to the photoinduced electron transfer (PET) between the photoexcited BrdU and the ground state TEA...
May 11, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28527414/structural-characterization-and-discrimination-of-the-paris-polyphylla-var-yunnanensis-and-paris-vietnamensis-based-on-metabolite-profiling-analysis
#10
Li-Ping Kang, Yuan-Yuan Huang, Zhi-Lai Zhan, Da-Hui Liu, Hua-Sheng Peng, Tie-Gui Nan, Yuan Zhang, Qing-Xiu Hao, Jin-Fu Tang, Shou-Dong Zhu, Guang Yang, Lan-Ping Guo, Min Chen, Lu-Qi Huang
This study aimed to distinguish the rhizomes of Paris polyphylla var. yunnanensis (Franch) Hand Mazz (PPY) and Paris veitnamensis (Takht.) H. Li (PV) using metabolomics-based ultra high-performance liquid chromatography coupled with quadrupole time-of-fligh mass spectrometry (UHPLC/Q-TOF MS). First, the UHPLC/Q-TOF MS approach was optimized for metabolite profiling. Then, the MS data were processed using UNIFI™ combined with an in-house library to automatically characterize the metabolites. Based on the exact mass information, the fragmentation characteristics, and the retention time of compounds, and the fragmentation mechanism and retention behavior of steroidal glycosides in the references, the structures identified by UNIFI were further verified...
May 11, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28525791/determination-of-thiopurine-s-methyltransferase-activity-by-hydrophilic-interaction-liquid-chromatography-hyphenated-with-mass-spectrometry
#11
Daniel Pecher, Svetlana Dokupilová, Zuzana Zelinková, Maikel Peppelenbosch, Veronika Mikušová, Peter Mikuš
Thiopurine S-methyltransferase (TPMT) plays an important role in the metabolism of thiopurines used in the therapy of inflammatory bowel diseases (IBD). In this work a new progressive method for the determination of TPMT activity in red blood cells lysates was developed. Analysis was carried out by means of hydrophilic interaction liquid chromatography (HILIC) hyphenated with mass spectrometry (MS). In comparison with reversed-phase high-performance liquid chromatography (RP-HPLC), that has been typically applied in determination of TPMT activity, the HILIC significantly improved the analytical signal provided by MS, shortened analysis time, and improved chromatographic resolution...
May 10, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28521274/detection-of-regulated-herbs-and-plants-in-plant-food-supplements-and-traditional-medicines-using-infrared-spectroscopy
#12
E Deconinck, C A Sokeng Djiogo, J L Bothy, P Courselle
The identification of a specific toxic or regulated plant in herbal preparations or plant food supplements is a real challenge, since they are often powdered, mixed with other herbal or synthetic powders and compressed into tablets or capsules. The classical identification approaches based on micro- and macroscopy are therefore not possible anymore. In this paper infrared spectroscopy, combined with attenuated total reflectance was evaluated for the screening of plant based preparations for nine specific plants (five regulated and four common plants for herbal supplements)...
May 8, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28511059/development-and-validation-of-a-rapid-reversed-phase-hplc-method-for-the-quantification-of-monoclonal-antibody-bevacizumab-from-polyester-based-nanoparticles
#13
Flávia Sousa, Virgínia M F Gonçalves, Bruno Sarmento
Bevacizumab is a powerful human monoclonal antibody approved worldwide for treatment of several types of cancer and ocular diseases due to its potential as antiangiogenic drug. Nowadays, in order to improve the monoclonal antibody-based therapy, attempts have been focused in the formulation of these biomacromolecules into nanoparticles. Thus, the aim of this work was to develop and validate a reversed-phase high-performance liquid chromatography with fluorescence detection method for the determination of bevacizumab from nanoparticulate systems, according to the International Conference on Harmonization guidelines...
May 8, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28525790/quantitative-lc-hrms-determination-of-selected-cardiovascular-drugs-in-dried-blood-spots-as-an-indicator-of-adherence-to-medication
#14
Dennis Bernieh, Graham Lawson, Sangeeta Tanna
Dried blood spot (DBS) sampling was investigated as a means of obtaining micro-volume blood samples for the quantitative analyses of ten commonly UK prescribed cardiovascular drugs as an indicator of medication adherence. An 8mm disc was punched out from each DBS from calibration, quality control and volunteer samples and extracted using methanol containing the internal standard. Each extract was evaporated to dryness, the residue reconstituted in methanol:water (40:60v/v) containing 0.1% formic acid and analysed by LC-HRMS...
May 6, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28514717/quantification-of-active-ingredients-in-semi-solid-pharmaceutical-formulations-by-near-infrared-spectroscopy
#15
Lisa B Schlegel, Manfred Schubert-Zsilavecz, Mona Abdel-Tawab
Near infrared (NIR) spectroscopy is increasingly gaining significance in the pharmaceutical industry for quality and in-process control. However, the potential of this method for quantitative quality control in pharmacies has long been neglected and little data is available on its application in analysis of creams and ointments. This study evaluated the applicability of NIR spectrometer with limited wavelength range (1000-1900nm) for quantitative quality control of six different dermatological semi-solid pharmaceutical preparations...
May 6, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28505590/apoptosis-induction-activity-and-molecular-docking-studies-of-survivin-sirna-carried-by-fe3o4-peg-lac-chitosan-pei-nanoparticles-in-mcf-7-human-breast-cancer-cells
#16
Sanam Arami, Majid Mahdavi, Mohammad-Reza Rashidi, Reza Yekta, Mohammad Rahnamay, Leila Molavi, Mohammad-Saeid Hejazi, Nasser Samadi
Delivery of small interfering RNAs (siRNAs) into cells still remains a challenge in gene delivery studies. Here, we investigated the ability of synthesized Fe3O4-PEG-LAC-chitosan-PEI nanoparticles for siRNA delivery of survivin as the model gene into cells. The cellular uptake of survivin siRNA carried by synthesized nanoparticles into MCF-7 breast cancer cell line was evaluated by florescent microscopy and flowcytometry, both proving the efficacy of nanoparticles in delivery of up to 64.7% in comparison with lipofectamine 2000...
May 6, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28501750/development-validation-and-application-of-a-novel-liquid-chromatography-tandem-mass-spectrometry-assay-measuring-uracil-5-6-dihydrouracil-5-fluorouracil-5-6-dihydro-5-fluorouracil-%C3%AE-fluoro-%C3%AE-ureidopropionic-acid-and-%C3%AE-fluoro-%C3%AE-alanine-in-human-plasma
#17
Ottiniel Chavani, Berit Packert Jensen, R Matthew Strother, Christopher M Florkowski, Peter M George
The plasma 5,6-dihydrouracil/uracil (UH2/U) ratio is a possible phenotypic marker of dihydropyrimidine dehydrogenase (DPD) activity, hence an index of 5-fluorouracil (5-FU) response and toxicity. Studies have re-affirmed the value of 5-FU and 5,6-dihydro-5-fluorouracil (FUH2) for therapeutic drug monitoring (TDM). However, FUH2 has limited stability in plasma, necessitating expedited plasma separation and freezing, where routine compliance may not be easy. The metabolites α-fluoro-β-ureidopropionic acid (FUPA) and α-fluoro-β-alanine (FβAL) are stable in plasma and are probable candidates for TDM...
May 6, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28538204/non-volatile-extractable-analysis-of-prefilled-syringes-for-parenteral-administration-of-drug-products
#18
Noemí Dorival-García, Iben Larsson, Jonathan Bones
The determination of extractable profiles for single-use technologies represents an important aspect of pharmaceutical production to minimize any possible compromise in drug product quality or potential risk to patients by identifying substances that may potentially leach from such devices. An approach for the extractable assessment of prefilled syringes, a promising alternative for parenteral administration of pharmaceutical products, is described herein. Four extraction solvents were selected: a mixture 2-propanol:water (1:1), was intended to represent aggressive conditions to extract a broad spectrum of extractables, including organic additives and substances which are poorly water-soluble...
May 5, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28501749/characterization-of-flavonol-mono-di-tri-and-tetra-o-glycosides-by-ultra-performance-liquid-chromatography-electrospray-ionization-quadrupole-time-of-flight-mass-spectrometry-and-its-application-for-identification-of-flavonol-glycosides-in-viola-tianschanica
#19
Yan Qin, Boyan Gao, Haiming Shi, Jie Cao, Chengle Yin, Weiying Lu, Liangli Yu, Zhihong Cheng
In this study, 21 flavonol O-glycoside standards including flavonol mono-, di-, tri- and tetra-O-glycosides have been systematically studied by ultra-high performance liquid chromatography-electrospray ionization-quadrupole time-of-flight mass spectrometry (UPLC-ESI-QTOF-MS/MS) in the negative ionization mode to analyze their fragmentation patterns. Here for the first time, the Z2(3-) fragment (corresponding to the loss of C-2" terminal sugar moiety) was observed in MS/MS spectra of flavonol 3-O-triglycosides...
May 5, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28501748/systematic-screening-and-characterization-of-prototype-constituents-and-metabolites-of-total-astragalosides-using-hplc-esi-it-tof-ms-n-after-oral-administration-to-rats
#20
Hong-Fu Li, Feng Xu, Ping Yang, Guang-Xue Liu, Ming-Ying Shang, Xuan Wang, Jun Yin, Shao-Qing Cai
Astragalosides (AGs) are the main bioactive constituents in Astragali Radix (AR), and have a wide range of pharmacological properties, including immunoregulatory, cardioprotective, neuroprotective, antioxidative, antidiabetic, and antinociceptive effects. However, the metabolism of total AGs remains unclear. To clarify the metabolic fate of AGs after oral administration to rats, total AGs were isolated from AR extracts using AB-8 macroporous resin chromatography and preparative HPLC, and then analyzed using HPLC-DAD-ELSD and LC-MS...
May 5, 2017: Journal of Pharmaceutical and Biomedical Analysis
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