Abstract：
:Charge variant profiling of therapeutic proteins is required by the International Council for Harmonisation guidelines and is traditionally performed by capillary electrophoresis or ion exchange chromatography. Recently, improvements in the hyphenation of capillary electrophoresis with mass spectrometry and the introduction of mass spectrometry compatible background electrolytes has allowed the implementation of native mass spectrometric determination of the charge variant profile obtained from the electrophoretic separation. The low flow operation of the microfluidic electrophoretic platform significantly boosts mass spectrometric sensitivity and increases the dynamic range, even when using sample amounts as low as 1 ng in capillary. In the current study, rituximab, trastuzumab and bevacizumab drug products were analysed using the ZipChip microfluidic CE-ESI-MS platform that facilitated confident identification of proteoforms with an average mass accuracy of <15 ppm. Up to 52 proteoforms were identified for trastuzumab drug product, while rituximab sample revealed the presence of fragments and sialylated N-glycans. Overall, the CE-ESI-MS platform proved to be a fast and robust tool for therapeutic protein charge variant profiling and facilitated efficient coupling with native mass spectrometry for the generation of highly informative characterisation data.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Carillo S,Jakes C,Bones Jdoi
10.1016/j.jpba.2020.113218subject
Has Abstractpub_date
2020-06-05 00:00:00pages
113218eissn
0731-7085issn
1873-264Xpii
S0731-7085(19)33031-6journal_volume
185pub_type
杂志文章abstract：:A liquid chromatography-tandem mass spectrometric (LC-MS/MS) method following chemical derivatization with 3-nitrophtalic anhydride was developed for the simultaneous determination of farnesol and geranylgeraniol in rat liver and testis. One analogue compound of the analytes, n-pentadecanol, was used as an internal st...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2008.01.032
更新日期：2008-07-15 00:00:00
abstract：:Chrome azurol S (CAS) was tested as a spectrophotometric reagent for the determination of imipramine (IMP). It reacts in aqueous media with IMP forming pink-red, sparingly soluble in water ion association compound. This compound was quantitatively extracted with chloroform and the absorbance of organic phase was measu...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(02)00314-x
更新日期：2002-10-15 00:00:00
abstract：:The spectral, solubility and related physicochemical characteristics of the ovarian hormone are presented. A review of its crystal properties indicates that the common crystalline form of the steroid is the hemihydrate. ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(87)80076-6
更新日期：1987-01-01 00:00:00
abstract：:Two HPLC-UV methods are described for the separate determination of artemether (AM) and the combined preservatives, methylparaben and propylparaben in a pharmaceutical dosage form. These analytes are contained in a dry suspension with a high amount of non-soluble excipients, some of which can interfere with the analys...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2006.07.053
更新日期：2007-01-17 00:00:00
abstract：:A monomer structure of a novel human insulin analog A22S-B3K-B31R (SK3R) has been characterized by NMR in water/acetonitrile solution and compared with the structure of human insulin (HIS) established in the same medium. The composition of the oligomer ensemble for neat insulins in water was qualitatively assessed by ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2016.12.005
更新日期：2017-02-20 00:00:00
abstract：:Capillary electrophoresis with conductivity detection is a selective and quantitative method for the analysis of counter cations, such as potassium, in pharmaceutical drug substances. It is also a sensitive and specific technique for screening and measuring inorganic impurities in drug substance samples. Both counter ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(99)00245-9
更新日期：2000-02-01 00:00:00
abstract：:The method is based upon the reaction between fluoride ions and the coloured complex of Fe(III) with methyl salicylate to form the stable, colourless hexaflouride complex of iron. The conditions of the method (pH, time and combination ratio) were studied and a standard curve was obtained for 0.01-0.08 mg NaF ml-1, at ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(96)01745-1
更新日期：1996-06-01 00:00:00
abstract：:A method is described for analysis of the tetracycline antibiotic minocycline using capillary zone electrophoresis. Potential impurities are 4-epiminocycline, 6-deoxy-6-demethyltetracycline, 7-didemethylminocycline, 7-monodemethylminocycline and 9-minocycline. Method development was undertaken with a mixture consistin...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(96)01732-3
更新日期：1996-06-01 00:00:00
abstract：:Topical formulations are medications applied locally on the skin to treat ailment. They are made up of complex mixtures of active ingredients and excipients. Till date, no analytical method has been found in literature that is able to simultaneously analyze volatile and semi-volatile actives present in topical formula...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.03.057
更新日期：2019-07-15 00:00:00
abstract：:Simultaneous isolation of Rutin and Esculin from pharmaceutical materials (plant--Flos hippocastani and drugs--Venescin, Venacorn) using solid-phase extraction (SPE) have been made. For this investigation the Bakerbond SPE columns with different unpolar and polar chemically bonded phases were used. On the basis of iso...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(93)80199-b
更新日期：1993-03-01 00:00:00
abstract：:A dedicated proteomic approach based on nano-Liquid Chromatography coupled with tandem mass spectrometry in ion trap is proposed for the analysis of proteins trapped in sorbent resin cartridges used to remove inflammatory mediators from blood by coupled plasma filtration adsorption (CPFA). The final purpose of the pro...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2016.10.009
更新日期：2017-01-05 00:00:00
abstract：:A high performance liquid chromatography coupled with atomic fluorescence spectrometry method for the determination of thimerosal (sodium ethylmercury thiosalicylate, C9H9HgNaO2S), ethylmercury, and inorganic mercury is proposed. Mercury vapor is generated by the post-column reduction of mercury species in formic acid...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2014.09.011
更新日期：2015-03-15 00:00:00
abstract：:This work deals with the preparation of single-labeled bioconjugates of the antibiotic Gentamicin (GT) with the sulforhodamine-derived fluorescence dye Texas Red(®)-X (TR), its purification by high-performance liquid chromatography (HPLC) and its characterization by high-resolution mass spectrometry. Aminoglycosides s...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2015.12.053
更新日期：2016-03-20 00:00:00
abstract：:Stable isotope analogues of phenytoin are useful for pulse dose pharmacokinetic studies in epilepsy patients. A simultaneous assay was developed to quantitate phenytoin (5,5-diphenylhydantoin) and its stable isotope analogue [13C3]-phenytoin (5,5-diphenyl-2,4,5-13C3-hydantoin) from plasma. Quantitation was achieved by...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(98)00018-1
更新日期：1998-09-01 00:00:00
abstract：:This review describes an epigrammatic impression of the recent trends in analytical perspectives of degradation and impurities profiling of pharmaceuticals including active pharmaceutical ingredient (API) as well as drug products during 2008-2012. These recent trends in forced degradation and impurity profiling were d...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/j.jpba.2013.07.013
更新日期：2013-12-01 00:00:00
abstract：:While capillary electrophoresis has been established as a major enantioseparation technique within the last decade, the potential of capillary electrochromatography is still studied extensively. This review summarizes recent applications of electromigration techniques with regard to the enantioseparation of chiral dru...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/s0731-7085(01)00653-7
更新日期：2002-01-15 00:00:00
abstract：:Methylnaltrexone (MNTX) is a novel peripherally acting μ-opioid antagonist that prevents peripheral side effects of opioid drugs such as constipation without affecting the analgesia. We developed a selective and sensitive assay to measure MTNX concentrations in human serum. The drug was measured after protein precipit...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2011.08.016
更新日期：2011-12-15 00:00:00
abstract：:To identify and quantify biologically active components in rat serum after orally administrating the decoction of Bulpleurum falcatum L. and Fractus aurantii, one of traditional Chinese medicines (TCMs), high-performance liquid chromatography (HPLC)-tandem mass spectrometry method was developed and validated. The HPLC...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.japna.2003.08.002
更新日期：2004-01-27 00:00:00
abstract：:Isoflavones are suitable guest molecules for inclusion complex formation with cyclodextrins (CDs). The molecular encapsulation with CDs results in a solid, molecularly dispersed form and in a significantly improved aqueous solubility of isoflavones. Genistein, a key isoflavone constituent of Ononidis spinosae radix wa...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2008.06.007
更新日期：2008-11-04 00:00:00
abstract：:A method is presented for the direct determination of mephenoxalone and acetaminophen in combined pharmaceutical dosage forms without prior separation. The first method, derivative-differential spectrophotometry, comprised of measurement of the difference absorptivities derivatized in the first order (deltaD1) of a ta...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(99)00157-0
更新日期：1999-11-01 00:00:00
abstract：:HPLC and TLC methods for monitoring of the photochemical stability of nimesulide are presented. Solution of nimesulide sodium salt was exposed to the light of wavelengths 254 nm. The presence of degradation products (2-phenoxy4-nitroaniline and methanesulfonic acid) was observed. In the exposed sample, 2-phenoxy4-nitr...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(02)00659-3
更新日期：2003-03-26 00:00:00
abstract：:Herein we describe for the first time a practical analytical method for determining the enantio-purity of L-α-glycerophosphocholine (L-α-GPC) by chiral derivatization. The use of a suitable chiral boronic acid allowed the formation of a mixture of two diastereomeric boronate esters whose ratio, carefully analyzed by 1...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2020.113152
更新日期：2020-05-10 00:00:00
abstract：:A simple, rapid, reliable and highly sensitive on-line two-dimensional reversed-phase liquid chromatography-tandem mass spectrometric (2D-LC/MS/MS) method to determine antiretroviral drugs viz., abacavir (ABC), nevirapine (NVP) and indinavir (IDV) in rat serum and urine was developed and validated. The analytes were e...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2009.07.005
更新日期：2009-12-05 00:00:00
abstract：:Several pharmacopoeias recommend the membrane filtration method for the sterility test of ophthalmic ointments. Isopropyl myristate, a fatty acid ester that exhibits high toxicity mainly against Gram-negative microorganisms, is indicated as a solvent for ointments. In this study, six fatty acid esters (diethyl adipate...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2006.05.018
更新日期：2006-11-16 00:00:00
abstract：:Liquid chromatography (LC) and capillary electrophoresis (CE) methods were developed to perform the determination of residual sodium in mother liquors and successive washes of an active pharmaceutical ingredient (API). The addition of sodium chloride to the product solution results in rapid and complete crystallizatio...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2006.07.020
更新日期：2007-07-27 00:00:00
abstract：:The validation of a microbiological assay, applying the cylinder-plate method, for the determination of the antibiotic azithromycin is described. Using a strain of Micrococcus luteus ATCC 9341 as the test organism, azithromycin at concentrations ranging from 0.1 to 0.4 microgml(-1) could be measured in capsules and su...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(02)00213-3
更新日期：2002-07-31 00:00:00
abstract：:A reversed phase high-performance liquid chromatography method was established for the first time to simultaneously qualify the seven major diterpenoids in Pseudolarix kaempferi, namely pseudolaric acid B O-beta-D-glucopyranoside (1), pseudolaric acid C2 (2), pseudolaric acid C1 (3), deacetylpseudolaric acid A (4), ps...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2007.03.005
更新日期：2007-07-27 00:00:00
abstract：:The electrochemical behaviour of a platinum(II) anti-tumour drug (cis-platin) has been investigated at the platinised platinum and carbon paste electrodes using cyclic voltammetry. Measurements performed in neutral aqueous media at the platinised platinum electrode as a function of free chloride ions have enabled the ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(88)80011-6
更新日期：1988-01-01 00:00:00
abstract：:Two methods are described for the simultaneous determination of tizanidine and rofecoxib in binary mixture. The first method was based on HPTLC separation of the two drugs followed by densitometric measurements of their spots at 311 nm. The separation was carried out on Merck HPTLC aluminium sheets of silica gel 60 F2...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2004.09.036
更新日期：2005-02-07 00:00:00
abstract：:Counterfeit and/or imitation medicines are becoming a major health problem not only in developing countries but also in wealthier countries. The need of new and easy analytical methods for quality control of drugs is essential. We describe the use of Raman spectroscopy, 1H nuclear magnetic resonance (NMR) and 2D diffu...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2007.12.033
更新日期：2008-05-12 00:00:00
