Abstract：
:Supercritical fluid chromatography (SFC) has long been a preferred method for enantiopurity analysis in support of pharmaceutical discovery and development, but implementation of the technique in regulated GMP laboratories has been somewhat slow, owing to limitations in instrument sensitivity, reproducibility, accuracy and robustness. In recent years, commercialization of next generation analytical SFC instrumentation has addressed previous shortcomings, making the technique better suited for GMP analysis. In this study we investigate the use of modern SFC for enantiopurity analysis of several pharmaceutical intermediates and compare the results with the conventional HPLC approaches historically used for analysis in a GMP setting. The findings clearly illustrate that modern SFC now exhibits improved precision, reproducibility, accuracy and robustness; also providing superior resolution and peak capacity compared to HPLC. Based on these findings, the use of modern chiral SFC is recommended for GMP studies of stereochemistry in pharmaceutical development and manufacturing.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Hicks MB,Regalado EL,Tan F,Gong X,Welch CJdoi
10.1016/j.jpba.2015.09.014subject
Has Abstractpub_date
2016-01-05 00:00:00pages
316-24eissn
0731-7085issn
1873-264Xpii
S0731-7085(15)30155-2journal_volume
117pub_type
杂志文章abstract：:Aurantio-obtusin, an anthraquinone isolated from cassiae semen, possesses diverse pharmacological activities, including hypotensive, hypolipidemic and anti-inflammatory effects. However, our previous studies demonstrated that exposure to aurantio-obtusin induced hepatotoxicity, but the mechanisms of the toxic effects ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
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abstract：:A sensitive and stereospecific high-performance liquid chromatography (HPLC) method for determination of sertraline in bulk drug, tablets and capsules was developed. Chromatography resolution of the sertraline enantiomeric forms and trans diastereoisomers was performed on Alltima C18 (250 mm x 4.6mm i.d., 5 microm) co...
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pub_type： 杂志文章
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abstract：:Platinum compounds, including cis-dichlorodiaminoplatinum(II) or cisplatin, are an important class of anti-cancer drugs, which should be carefully monitored in the biological fluids. In this study, electrodeposition coupled with electrothermal atomic absorption spectrometry (ETAAS) was used for determination of Pt con...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2010.02.023
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abstract：:The development of biosensor technologies for the investigation of biomolecular interactions has markedly advanced over the last years. One promising biosensor platform, the Bio-Layer Interferometry (BLI), was developed by ForteBio with the main focus to qualify and quantify protein/protein interactions in research an...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2012.10.008
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abstract：:Rhizoma Curcumae (RC) is perennial herbaceous plant mainly present in China, India and Malaysiabelong, which is belong to the family Zingiberaceae. The rhizomes of RC have been used as a famous traditional Chinese medicine for the treatment of syndrome of blood stasis. A selective, sensitive and accurate gas chromatog...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2017.11.058
更新日期：2018-02-05 00:00:00
abstract：:Camazepam [3-(N,N-dimethyl)carbamoyloxy-7-chloro-1-methyl-1, 3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one, CMZ] possesses anxiolytic, anticonvulsant, muscle relaxant and hypnotic properties. CMZ is clinically used as a racemate. The enantioselective metabolism of racemic CMZ by rat liver microsomes was studied. Major...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
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journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2017.07.011
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abstract：:CpG oligodeoxynucleotide 107 (CpG ODN107) could be used as a novel radiosensitizer for glioma. Herein, a novel and sensitive reversed-phase HPLC coupled with electrospray triple quadrupole mass spectrometry (LC-MS/MS) following a one-step C18 solid-phase extraction (SPE) for biological matrix removal was developed and...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2012.06.022
更新日期：2012-11-01 00:00:00
abstract：:A rapid and simple LC-MS/MS method was developed and validated for the simultaneous determination of coniferyl ferulate (CF) and its metabolite coniferyl alcohol (CA) using bavachromene as an internal standard (IS). A TSQ Quantum Access mass spectrometer was operated under selected-reaction monitoring mode using negat...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2017.08.033
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journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/j.jpba.2016.05.007
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abstract：:Thiazolidinediones are known for their activity against Type 2 diabetes and are currently being repurposed for their potent anti-cancer activity. In the present study, we have assessed in vitro metabolic properties and in vivo pharmacokinetic parameters of a novel thiazolidinedione derivative, BIT-15-67, a potential a...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.113000
更新日期：2020-02-05 00:00:00
abstract：:The leaves of Ziziphus jujuba and Z. jujuba var. spinosa have been utilized as crude drugs for their health benefits in China for thousands of years. To control their quality, a reliable method based on high-performance liquid chromatography coupled with photo diode array and electrospray ionization tandem mass spectr...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2011.05.025
更新日期：2011-09-10 00:00:00
abstract：:Two monoglucuronides (CA1G1 and CA1G2) of the catecholic cis-stilbene Combretastatin A1 (CA1, OXi4500), have been identified in a clinical trial of the bisphosphate prodrug of OXi4500, OXi4503. A validated assay for the two glucuronides in human plasma using HPLC with fluorescence detection after post-column photolysi...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2011.12.022
更新日期：2012-03-25 00:00:00
abstract：:A rapid clean-up procedure based on solid-phase extraction (SPE) and HPLC determination of lincomycin in premixes with UV detection is described. After extraction of lincomycin from premix with extraction solvent the extract is applied to OASIS HLB column treated with methanol and water. Lincomycin is eluted with meth...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2005.07.041
更新日期：2006-03-03 00:00:00
abstract：:Curcumin, a principal curcuminoid of turmeric, gained a lot of attention recently due to its wide spectrum of pharmacological activities in prevention and treatment of various human conditions. The current clinical study is focused on the determination of efficacy and tolerability of curcumin and vitamin D3 combinatio...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2018.04.034
更新日期：2018-07-15 00:00:00
abstract：:Simple spectrophotometric and spectrofluorimetric methods are suggested for the determination of antifungal drugs; clotrimazole, econazole nitrate, ketoconazole, miconazole and tolnaftate. Spectrophotometric one depends on the interaction between imidazole antifungal drugs as n-electron donor with the pi acceptor 2,3-...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(99)00280-0
更新日期：2000-03-01 00:00:00
abstract：:Juglone (JL), as one of the major bioactive components present in the bark of Juglans mandshruica Maxim, exhibits versatile bioactivities, especially anti-cancer activity. To better understand the pharmacokinetic properties of juglone, the protein binding rate of juglone was determined by ultrafiltration method, and t...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2017.03.036
更新日期：2017-07-15 00:00:00
abstract：:A simple HPLC-UV method was established for the determination of orientin in plasma and different tissues of rat (heart, liver, spleen, lung, kidney, brain, stomach and small intestine). The separation was achieved by HPLC on a C(18) column with a mobile phase composed of acetonitrile-0.1% acetic acid (20:80, v/v), UV...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2008.01.035
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journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2004.11.013
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journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
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journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
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journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2013.07.005
更新日期：2013-11-01 00:00:00
abstract：:The contamination of commonly used supplements by unknown steroids as well as their metabolites (parent compounds) become a challenge for the analytical laboratories. Although the determination of steroids profile is not trivial because of the complex matrix and low concentration of single compound, one of the most di...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2014.11.017
更新日期：2015-03-15 00:00:00
abstract：:UPLC-UV and HPLC-TOF-MS methods have been developed for the analysis of major sesquiterpenes and pyrrolizidine alkaloids from rhizomes of Petasites hybridus (L.) G.M. et Sch. (Family, Asteracea) and dietary supplements claiming to contain P. hybridus. The best results were obtained with Acquity UPLC™ HSS T3 (100 mm × ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2012.05.021
更新日期：2012-11-01 00:00:00
abstract：:In the present study, an accurate, simple and fast bioanalytical method based on ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) technique for simultaneous quantification of plasma selexipag and its main metabolite ACT-333679 concentrations in rats was optimized and established. The purpo...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
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更新日期：2020-10-25 00:00:00
abstract：:Salmeterol xinafoate is the first of a new class of long acting, selective beta2-adrenoceptor agonists introduced for the treatment of asthma. The major metabolite of salmeterol in the dog has been identified as the 3-catechol sulphate of the benzoic acid derivative. This metabolite was isolated from dog bile and was ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(98)00114-9
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abstract：:Biotin labelled with a cymantrene moiety (cyclopentadienyl manganese tricarbonyl complex) is described for the first time. Because this metallo-biotin retains full recognition for the specific glycoprotein avidin (or streptavidin), the labelled streptavidin-biotin system is proposed for use in a solid-phase competitio...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(91)80031-4
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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 rapid, selective and stability indicating high performance liquid chromatographic method was developed and validated for the estimation of venlafaxine in pharmaceutical dosage forms. The analysis was done on a Spherisorb C8 (4.6 x 250 mm, 5 microm) column. The mobile phase consisted of acetonitrile:sodium dihydrogen...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(01)00701-4
更新日期：2002-06-15 00:00:00
abstract：:A non-aqueous capillary electrophoresis method for the determination of oxytetracycline in an ointment have been validated. The oxytetracycline (OTC) is separated from related impurities and degradation products as metal chelates with magnesium ions. Thus, the method show high selectivity. The sample preparation is pe...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(96)01998-x
更新日期：1997-05-01 00:00:00
