Abstract：
:The objective of current study was to develop a validated specific stability indicating reversed-phase liquid chromatographic method for the quantitative determination of levofloxacin as well as its related substances determination in bulk samples, pharmaceutical dosage forms in the presence of degradation products and its process related impurities. Forced degradation studies were performed on bulk sample of levofloxacin as per ICH prescribed stress conditions using acid, base, oxidative, water hydrolysis, thermal stress and photolytic degradation to show the stability indicating power of the method. Significant degradation was observed during oxidative stress and the degradation product formed was identified by LCMS/MS, slight degradation in acidic stress and no degradation was observed in other stress conditions. The chromatographic method was optimized using the samples generated from forced degradation studies and the impurity spiked solution. Good resolution between the peaks corresponds to process related impurities and degradation products from the analyte were achieved on ACE C18 column using the mobile phase consists a mixture of 0.5% (v/v) triethyl amine in sodium dihydrogen orthophosphate dihydrate (25 mM; pH 6.0) and methanol using a simple linear gradient. The detection was carried out at 294 nm. The limit of detection and the limit of quantitation for the levofloxacin and its process related impurities were established. The stressed test solutions were assayed against the qualified working standard of levofloxacin and the mass balance in each case was in between 99.4 and 99.8% indicating that the developed LC method was stability indicating. Validation of the developed LC method was carried out as per ICH requirements. The developed LC method was found to be suitable to check the quality of bulk samples of levofloxacin at the time of batch release and also during its stability studies (long term and accelerated stability).
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Lalitha Devi M,Chandrasekhar KBdoi
10.1016/j.jpba.2009.05.038subject
Has Abstractpub_date
2009-12-05 00:00:00pages
710-7issue
5eissn
0731-7085issn
1873-264Xpii
S0731-7085(09)00353-7journal_volume
50pub_type
杂志文章abstract：:Gas chromatography-mass spectrometry (GC-MS) and high performance liquid chromatography (HPLC) offer highly efficient and potentially sensitive separation and detection techniques. This work describes the quantification of aminoglutethimide (AG) in nanocapsules suspension with both techniques. The analysis of differen...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2004.02.030
更新日期：2004-06-29 00:00:00
abstract：:A simple method for the simultaneous determination of five bioactive components (rutin, puerarin, daidzein esculin and esculetin) in traditional medicinal preparations by non-aqueous capillary electrophoresis with UV detection has been developed for the first time. A running buffer composed of 15% acetonitrile, 2.5% a...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2005.03.018
更新日期：2005-09-01 00:00:00
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
更新日期：2010-09-21 00:00:00
abstract：:The traditional Chinese medicine 'Qing Kai Ling' injection after deterioration is distinguished from the original formulation using Fourier-transform infrared spectroscopy (FTIR) and two-dimensional correlation infrared spectroscopy (2D-IR). The IR spectra of the injections before and after deterioration are so simila...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(02)00485-5
更新日期：2003-01-01 00:00:00
abstract：:A simple, specific and reliable 1H-NMR spectroscopic method for the quantitative determination of the optical purity of indacrinone is described. After conversion of the S(+)- and R(-)-enantiomers to their methyl ester derivatives, they were coordinated with chiral europium(III) or praseodymium(III) shift reagents in ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(89)80016-0
更新日期：1989-01-01 00:00:00
abstract：:A rapid and sensitive ultra performance liquid chromatography-tandem mass spectrometry method was developed for simultaneous determination of eight constituents, uralsaponin C, uralsaponin F, 22β-acetoxyl-glycyrrhizin, 24-hydroxy-licorice-saponin E2, licorice-saponin G2, licorice-saponin E2, glycyrrhizin, and licorice...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2012.11.035
更新日期：2013-03-05 00:00:00
abstract：: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 station...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2017.05.047
更新日期：2017-09-05 00:00:00
abstract：:The assessment of polymorphism is a problematical issue for regulatory agencies, because variations among crystalline forms of active pharmaceutical ingredient (API) can lead to changes in the efficacy and safety of formulated product. Such conversions are very hard to be detected, thus, the development of techniques ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.03.021
更新日期：2019-06-05 00:00:00
abstract：:This report describes the fabrication and the application of a novel carbon nanotube (CNT)-epoxy composite electrode as a sensitive amperometric detector for the capillary electrophoresis (CE). The composite electrode was fabricated on the basis of the in situ polycondensation of a mixture of CNTs and 1,2-ethanediamin...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2015.07.044
更新日期：2015-11-10 00:00:00
abstract：:This paper deals with the chiral separation of optical isomers of beta-methyl-amino acids by CE and HPLC using the principle of ligand-exchange. Capillary zone electrophoresis was carried out using Cu(II) complexes of L-4-hydroxyproline (L-4-Hypro), N-(2-hydroxypropyl)-L-4-hydroxyproline (HP-L-4-Hypro) and N-(2-hydrox...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(01)00616-1
更新日期：2002-01-15 00:00:00
abstract：:Human exposure to aldehydes is implicated in several diseases including cancer. These strong electrophilic compounds can react with nucleophilic sites in DNA to form reversible and irreversible modifications. These modifications, if not repaired, can contribute to pathogenesis. The aim of our study was to provide a ma...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.113007
更新日期：2020-02-05 00:00:00
abstract：:A simple, rapid and efficient microextraction method for the extraction and determination of some 2-pyrazoline derivative compounds in aqueous samples was developed. Microliter volumes of 1-undecanol were delivered to the surface of the aqueous sample and the sample was agitated for a desire time. The sample vial was ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2008.07.029
更新日期：2008-12-01 00:00:00
abstract：:A capillary electrophoresis method using cyclodextrins as the chiral selectors was developed for the determination of carvedilol enantiomers in serum. Several types of cyclodextrins were evaluated. The effect of cyclodextrin concentration on enantiomer resolution was investigated. Best results were obtained using 10 m...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(00)00468-4
更新日期：2001-02-01 00:00:00
abstract：:Ilimaquinone, a metabolite isolated from the marine sponge Hippiospongia metachromia, has antimicrobial, cytotoxic, anti-HIV, anti-inflammatory, and anti-cancer activities. A new quantitative analytical method for determination of ilimaquinone in rat plasma using HPLC-MS/MS was developed and validated. Ascorbic acid w...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.01.030
更新日期：2019-03-20 00:00:00
abstract：:It is shown that activity in the area of chemically modified electrodes continues at a high level. This topic is increasing in popularity with a large research field on the incorporation of electroactive groups into a variety of conductive films. These developments are also directed towards catalyzing bioselective and...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(86)80089-9
更新日期：1986-01-01 00:00:00
abstract：:Many new phenothiazines exhibit promising anticancer and antibacterial activities, reversal of multidrug resistance and potential treatment in Alzheimer's, Creutzfeldt-Jakob and AIDS diseases. Their synthesis may proceed through a stage of the Smiles rearrangement and may lead to different products: cyclic phenothiazi...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2011.02.026
更新日期：2011-06-01 00:00:00
abstract：:Solid phase extraction (SPE) and HPLC were used for simultaneous determination of hesperidin, diosmin and eriocitrin in Iranian lime juice samples. The method involved very simple efficient SPE with polyamide cartridge, the use of mixture of water/acetonitrile/acetic acid (78:19:3, v/v) as a mobile phase at a flow rat...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2011.05.015
更新日期：2011-09-10 00:00:00
abstract：:A rapid, simple and sensitive liquid chromatography-mass spectrometry (LC-MS) method was developed and validated for the determination of the imidazole H(3) antagonist ROS203 in rat plasma, using the superior homologue ROS287 as internal standard. Analyses were performed on an Agilent 1100 Series HPLC system employing...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2007.09.010
更新日期：2008-01-07 00:00:00
abstract：:An ion-pair reversed phase liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed for the quantification of a phosphorothioate oligonucleotide (PS-OGN) PF-ODN and its metabolites 5'N-1/3'N-1, 5'N-2 and 5'N-3 in rat plasma. Plasma samples were prepared with an initial phenol/dichloromethane...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2010.01.040
更新日期：2010-08-01 00:00:00
abstract：:A simple reversed-phase high-performance liquid chromatography (HPLC) method was developed for the simultaneous estimation of the antiepileptic drugs (AEDs) lamotrigine (LTG), phenobarbitone (PB), carbamazepine (CBZ) and phenytoin (PHT) in human serum. The procedure involves extraction of the AEDs by mixing 200 microl...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2005.02.045
更新日期：2005-09-01 00:00:00
abstract：:A new carbon paste electrode selective for piribedil (PD) was prepared and fully characterized in terms of composition, usable pH range, response time and thermal stability. The electrode active recognition is by liquid ion-exchange mechanism via the use of piribedil phosphomolybdate as ion-exchanger dissolved in tric...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2005.02.006
更新日期：2005-07-15 00:00:00
abstract：:A gradient high-performance liquid chromatographic (HPLC) method was developed for the analysis of Synercid freeze-dried powder in routine quality control, stability and compatibility studies. This method is suited for a simultaneous assay of drug substances and impurities. The method was validated for precision, repr...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(98)00242-8
更新日期：1999-04-01 00:00:00
abstract：:A simple analytical method for l-menthol by high-performance liquid chromatography with a polarized photometric detector was established. The polarized photometric detector was constructed with two polarizers mounted on both sides of the flow cell in a conventional photometric detector and can be easily used for the d...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(97)00146-5
更新日期：1998-04-01 00:00:00
abstract：:A novel sensor based on a modification of glassy carbon electrode (GCE) with NH2-functionalized multi-walled carbon nano-tubes (NH2fMWCNTs) is reported and its applicability to the electrochemical sensing of Propafenone (PPF) demonstrated. The electrochemical catalytic activity was also utilized as a sensitive detecti...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.06.026
更新日期：2019-09-10 00:00:00
abstract：:This study is based on a plan of collecting different matrices (hair, eye, muscle, liver and kidney) in order to define a strategy for the control of the illegal use of clenbuterol in bovine production. Of all matrices utilised, hair is recommended for the analytical control of clenbuterol in living animals, due to it...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(03)00073-6
更新日期：2003-06-01 00:00:00
abstract：:Banxia Xiexin decoction (BXD) is an effective Chinese Medicinal Prescription in treating gastroenteritis diseases. In this study an ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was developed to separate and determine 18 major active ingredients of BXD in order to guarantee ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2013.10.002
更新日期：2014-01-01 00:00:00
abstract：:Enantiomers of clenbuterol were directly separated by a new high performance chromatographic method on Chirex 3005 column. Several parameters such as mobile phase composition, column temperature and flow rate were studied. Baseline enantioseparation was achieved, using the optimized mobile phase of n-hexane-1,2-dichol...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(02)00671-4
更新日期：2003-02-26 00:00:00
abstract：:Simple and express coulometric method for the evaluation of the total antioxidant capacity (TAC) of human plasma based on the reaction with electrogenerated bromine is applied. TAC of plasma from patients with different ethiology of chronic renal failure was observed. The levels of antioxidant capacity for venous and ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 临床试验,杂志文章
doi：10.1016/j.jpba.2005.08.017
更新日期：2006-03-03 00:00:00
abstract：:Zishen Yutai Pills (ZYP) is a well-known Chinese patent medicine which has been used to prevent recurrent miscarriage and treat threatened abortion in China. In this study, a comprehensive strategy combining ultrahigh performance liquid chromatography coupled with charged aerosol detector (UHPLC-CAD) fingerprint and m...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2020.113570
更新日期：2020-11-30 00:00:00
abstract：:A rapid, sensitive and selective high-performance liquid chromatography tandem mass spectrometric method (HPLC-MS) has been developed and validated for the simultaneous determination of matrine (MT), oxymatrine (OMT) and oxysophocarpine (OSP) in rat plasma after oral administration of Sophora flavescens Ait. extract u...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2008.03.019
更新日期：2008-08-05 00:00:00
