Abstract:
:Sunitinib is approved for advanced renal cell cancer, imatinib-resistant or -intolerant gastrointestinal stromal tumors and pancreatic neuroendocrine cancers. It is prescribed at a fixed dose but its plasma exposure shows large inter-individual variations. Taking into account the narrow therapeutic window and the positive exposure-efficacy relationship, there is a robust rationale for its therapeutic drug monitoring. In fact, a target plasma concentration of sunitinib plus its active metabolite, N-desethyl sunitinib, ≥50 ng/mL was suggested. In order to quantify sunitinib and N-desethyl sunitinib in patients' plasma, we developed and validated a new LC-MS/MS method applicable to clinical routine. In solution, sunitinib and N-desethyl sunitinib undergo to photo-isomerization and many published methods overcome this problem by conducting the entire procedures of samples collection and handling under strictly light-protection. Our method is based on a simple and fast procedure that quantitatively reconverts the E-isomer of both analytes, obtained during sample draw and processing without light-protection, into their Z-forms. Moreover, our method uses a small plasma volume (30 μL) and the analytes are extracted by a rapid protein precipitation. It was validated according to EMA-FDA guidelines. The calibration curves resulted linear (R2 always >0.993) over the concentration ranges (0.1-500 ng/mL for sunitinib, 0.1-250 ng/mL for N-desethyl sunitinib) with a good precision (within 7.7 % for sunitinib and 10.8% for N- desethyl sunitinib) and accuracy (range 95.8-102.9% for sunitinib and 92.3-106.2% for N-desethyl sunitinib). This method was applied to a pharmacokinetic study in one patient treated with sunitinib. Moreover, as incurred samples reanalysis is an established part of the bioanalytical process to support clinical studies, its assessment was performed early in order to assure that any reproducibility issues was detected as soon as possible. The percentage difference between the two runs resulted within ±20% in all the re-analysed samples for both sunitinib and N- desethyl sunitinib.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Marangon E,Buzzo M,Posocco B,Gagno S,Zanchetta M,Iacuzzi V,Poetto AS,Guardascione M,Giodini L,Toffoli Gdoi
10.1016/j.jpba.2019.112949subject
Has Abstractpub_date
2020-02-05 00:00:00pages
112949eissn
0731-7085issn
1873-264Xpii
S0731-7085(19)31570-5journal_volume
179pub_type
杂志文章abstract::The purpose of this study was to investigate the in vitro release of 5-aminosalicylic acid from single extrudates by UV imaging and to explore the technique as a visualization tool for detecting film coating defects on extrudates coated with a thin ethyl cellulose layer. 5-Aminosalicylic acid extrudates were film coat...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2013.04.028
更新日期:2013-09-01 00:00:00
abstract::Nanoformulations are complex systems where physicochemical properties determine their therapeutic efficacy and safety. In the case of nanovaccines, particle size and shape play a crucial role on the immune response generated. Furthermore, the antigen's integrity is also a key aspect to control when producing a nanovac...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2019.113017
更新日期:2020-02-05 00:00:00
abstract::Recent data clearly show that the gut microbiota plays a significant role in the biotransformation of many endogenous molecules and xenobiotics, leading to a potential influence of this microbiotic metabolism on activation, inactivation and possible toxicity of these compounds. To study the colonic biotransformation o...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2019.07.016
更新日期:2019-10-25 00:00:00
abstract::Amphetamine, methamphetamine, phentermine, 3,4-methylenedioxyamphetamine (MDA), 3,4-methylenedioxymethamphetamine (MDMA), and 3,4-methylenedioxy-N-ethylamphetamine (MDEA) are the most popular amphetamine-type stimulants. The use of these substances is a serious societal problem worldwide. In this study, a method based...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2017.09.020
更新日期:2018-01-30 00:00:00
abstract::High-molecular-weight hyaluronan (HA) samples were exposed to free-radical chain-degradation reactions induced by ascorbate in the presence of Cu(II) ions - the so-called Weissberger's oxidative system. The concentrations of both reactants [ascorbate, Cu(II)] were comparable to those that may occur during an early sta...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2011.06.015
更新日期:2011-11-01 00:00:00
abstract::A novel and quick high-performance liquid chromatography (HPLC) method with UV spectrophotometric detection was developed and validated for the determination of five compounds in topical gel. The described method is suitable for simultaneous determination of active component ketoprofen, two preservatives methylparaben...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2004.07.018
更新日期:2004-11-15 00:00:00
abstract::The purpose of this study was two-fold: (1) to develop a simple and sensitive screening procedure for identifying and confirming bromhexine and ambroxol and, (2) to determine the effect of furosemide on the detection of bromhexine, ambroxol, or their metabolites in urine. Female horses (450-550 kg) treated with bromhe...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/0731-7085(91)80234-z
更新日期:1991-01-01 00:00:00
abstract::Polysorbate 80 is used in the pharmaceutical industry as an additive to enhance the solubility of non-polar compounds in formulation design and during dissolution analysis. In this paper we present the spectroscopic and chromatographic characteristics for a series of commercially available sources of this non-ionic su...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2006.01.020
更新日期:2006-06-07 00:00:00
abstract::LC-UV scan of lisinopril revealed the presence of an unknown impurity (approximately 0.14%) at a relative retention time of 3.26 employing phosphate buffer-acetonitrile as binary gradient system while LC-MS analysis with binary gradient system comprising of a ammonia-ammonium acetate buffer (pH 5.0) and acetonitrile i...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2006.06.046
更新日期:2007-01-04 00:00:00
abstract::A method for routine base composition determination of phosphorothioate oligonucleotides containing as many as 21 nucleobases has been developed and systematically evaluated in terms of factors contributing to assay precision and accuracy. Phosphorothioate internucleotide linkages were oxidized with a mixture of tetra...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/0731-7085(94)00099-9
更新日期:1994-11-01 00:00:00
abstract::A sensitive and selective liquid chromatographic method coupled with tandem mass spectrometry (LC-MS/MS) was developed for the quantification of ambroxol in human plasma. Domperidone was used as internal standard, with plasma samples extracted using diethyl ether under basic condition. A centrifuged upper layer was th...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/s0731-7085(03)00059-1
更新日期:2003-06-01 00:00:00
abstract::Stroke is the third most common cause of death in most industrialized countries. Polygonum multiflorum (He-Shou-Wu, HSW) is one of the traditional Chinese medicines with multiple pharmacological activities which is widely used in Chinese recipe. This study aims to explore the protective effect of HSW on ischemic strok...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2018.03.049
更新日期:2018-06-05 00:00:00
abstract::The methods for analysis of platinum-based anti-cancer drugs in biological media are reviewed in this paper. Although emphasis is placed on cisplatin, attention is also given to several of its analogues (carboplatin, iproplatin) and their degradation and biotransformation products. In an introductory section a short d...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章,评审
doi:10.1016/0731-7085(90)80003-8
更新日期:1990-01-01 00:00:00
abstract::To know the interaction of cefodizime (CEF) with human serum albumin (HSA), techniques of different spectroscopies and molecular modeling were used. The inner filter effects were eliminated to get accurate binding parameters. Steady state fluorescence suggested a static type for CEF-HSA interaction, and the complex fo...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2015.01.010
更新日期:2015-03-25 00:00:00
abstract::Understanding the origin and fate of organic impurities within the manufacturing process along with a good control strategy is an integral part of the quality control of drug substance. Following the underlying principles of quality by design (QbD), a systematic approach to analytical control of process impurities by ...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2010.01.043
更新日期:2010-08-01 00:00:00
abstract::The purpose of this study was to investigate whole-dosage form UV-vis imaging as a potential tool for functional characterization of excipients used in solid oral dosage forms. To this end, tablets (average mass 260.0 mg, 224.5 mg and 222.1 mg) containing theophylline anhydrate (20 % w/w), 1% (w/w) magnesium stearate,...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2020.113789
更新日期:2021-02-05 00:00:00
abstract::A simple, rapid and sensitive method for the determination of nicotine, cotinine, nornicotine, anabasine, and anatabine in human urine and saliva was developed. These compounds were analyzed by on-line in-tube solid-phase microextraction (SPME) coupled with liquid chromatography-mass spectrometry (LC-MS). Nicotine, co...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2008.09.044
更新日期:2009-01-15 00:00:00
abstract::A method development process is commonly finalized by a method transfer from the developing to the routine laboratory. Statistical tests are performed in order to survey if a transfer succeeded or failed. However, using the classic two-sample t-test can lead to misjudgments and unsatisfying transfer results due to its...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章,评审
doi:10.1016/j.jpba.2010.04.034
更新日期:2010-12-15 00:00:00
abstract::A new analytical method for chloramphenicol and its derivatives, chloramphenicol succinate sodium and D-(-)-threo-2-amino-L-[p-nitrophenyl]-1,3-propanediol (chloramphenicol base) in the pure state or in pharmaceutical preparations, is described. The method is based on measuring the blue colour produced by the interact...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/0731-7085(87)80068-7
更新日期:1987-01-01 00:00:00
abstract::Most drugs are excreted into breast milk to some extent and are bioavailable to the infant. The ability to predict the approximate amount of drug that might be present in milk from the drug structure would be very useful in the clinical setting. The aim of this research was to simplify and upgrade the previously devel...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章,评审
doi:10.1016/s0731-7085(02)00037-7
更新日期:2002-06-20 00:00:00
abstract::A simple and rapid spectrophotometric assay is described for bronopol determination in raw material. The method is based on the measurement of absorbance (at 244 nm) of bromonitroethanol (sodium salt of aci-form), the chromophoric derivative formed from bronopol instantaneously by a retroaldol reaction in the presence...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/0731-7085(96)01779-7
更新日期:1996-08-01 00:00:00
abstract::Pharmaceutical heroin for inhalation was developed for a clinical trial on co-prescription of heroin and methadone to chronic treatment-resistant heroin addicts. Diacetylmorphine base was selected as the active pharmaceutical ingredient for this product with caffeine anhydrate added as an excipient. Differential scann...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2005.06.011
更新日期:2005-10-04 00:00:00
abstract::An account is given of the development of tests for the bio-assay of insulin and the progress made, at the Wellcome Foundation Limited, during the last 30 years in reducing the number of animals used in the testing of insulin for the treatment of Diabetes Mellitus. The progressive evolution of methods shows how the nu...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章,评审
doi:10.1016/0731-7085(89)80083-4
更新日期:1989-01-01 00:00:00
abstract::The World Health Organization accepts chromatographic fingerprints as a tool for identification and quality control of herbal medicines. This is the first study in which the distinction, identification and quality control of four different Artemisia species, i.e. Artemisia vulgaris, A. absinthium, A. annua and A. capi...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2014.02.006
更新日期:2014-07-01 00:00:00
abstract::The interaction between gabapentin (GP), a neuroleptic drug, and calf-thymus DNA was investigated. Cyclic voltammetry and different spectroscopic methods (UV/vis spectrophotometry, spectroflourimetry and circular dichroism) were used to study the process. The oxidation current of GP was considerably decreased in the p...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2012.06.005
更新日期:2012-11-01 00:00:00
abstract::Morroniside is an important constituent of traditional Chinese medicines Fructus Corni with several bioactivities. An HPLC method for determination of morroniside in rat plasma and tissues was developed and the pharmacokinetic and tissue distribution characteristics of morroniside after intravenous and oral administra...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2007.05.013
更新日期:2007-10-18 00:00:00
abstract::Sinoporphyrin sodium (DVDMS) is a new photosensitizer (PS) and it is used in photodynamic therapy (PDT) against tumor. In this paper, a simple, rapid and specific ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for the quantitation of DVDMS in human plasma was developed. The analyt...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2020.113852
更新日期:2021-02-20 00:00:00
abstract::Concentrated solutions of doxycycline are often added to drinking water of animals for oral antibiotic therapy. However, stability concerns of doxycycline in solution involve an accurate selection of the solvent system to ensure that the active substance will remain within the acceptance range during the product shelf...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2018.06.054
更新日期:2018-09-10 00:00:00
abstract::A sensitive, selective and robust qualitative and quantitative densitometric high-performance thin layer chromatographic method was developed and validated for the determination of iridoid glycoside in the aerial part of Gambhari (Gmelina arborea). Iridoid gycoside 6-O-(2'',3''-dibenzoyl)-alpha-l-rhamnopyranosylcatalp...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2008.04.012
更新日期:2008-08-05 00:00:00
abstract::The similarities and differences of essential oil components in Pericarpium Citri Reticulatae Viride (PCRV) and Pericarpium Citri Reticulatae (PCR) were investigated by GC-MS combined with a chemometric method, named alternative moving window factor analysis (AMWFA). Furthermore, temperature-programmed retention indic...
journal_title:Journal of pharmaceutical and biomedical analysis
pub_type: 杂志文章
doi:10.1016/j.jpba.2007.08.030
更新日期:2008-01-07 00:00:00