Document Detail


Validated ion pair liquid chromatography/fluorescence detection method for assessing the variability of the loratadine metabolism occurring in bioequivalence studies.
MedLine Citation:
PMID:  17497754     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Inter- and intra-individual variability of the loratadine (LOR) metabolism in Caucasian subjects was assessed during a bioequivalence study for two pharmaceutical formulations (solid oral dosage forms) containing 10 mg of the active substance. The analytical data were obtained by applying a reliable, low-cost and sensitive ion pair liquid chromatography/fluorescence (IPLC/FLD) method for determination of both loratadine and descarboethoxyloratadine (DCL) in human plasma samples. The sample preparation procedure is based on liquid-liquid extraction of the target analytes from alkalinized plasma using diethyl-ether. The separation of the analytes and 8-chloroazatadine as internal standard (IS) was achieved through an isocratic ion pair (IP) elution on a Purospher((R)) STAR RP-18 column. The mobile phase containing sodium dodecyl sulfate (SDS) as ion pairing agent was pumped at a flow rate of 1 mL/min. Fluorescence detection (FLD) was achieved at 280 nm (excitation) and 440 nm (emission) wavelengths. The increased sensitivity of the method is also based on a large sample injected volume (250 microL). Linear response was found over the 0.5-20 ng/mL concentration interval for both target compounds. Low limits of quantification (LLOQ) around 0.3 ng/mL were found for LOR and DCL. Method validation is presented.
Authors:
Daniela Iuliana Sora; Stefan Udrescu; Victor David; Andrei Medvedovici
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Publication Detail:
Type:  Evaluation Studies; Journal Article; Validation Studies    
Journal Detail:
Title:  Biomedical chromatography : BMC     Volume:  21     ISSN:  0269-3879     ISO Abbreviation:  Biomed. Chromatogr.     Publication Date:  2007 Oct 
Date Detail:
Created Date:  2007-09-13     Completed Date:  2007-12-20     Revised Date:  2013-06-03    
Medline Journal Info:
Nlm Unique ID:  8610241     Medline TA:  Biomed Chromatogr     Country:  England    
Other Details:
Languages:  eng     Pagination:  1023-9     Citation Subset:  IM    
Copyright Information:
2007 John Wiley & Sons, Ltd
Affiliation:
SC Labormed Pharma S.A., Splaiul Independentei no. 319 E, Bucharest 060044, Romania.
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adolescent
Adult
Chromatography, High Pressure Liquid / instrumentation*,  methods
Drug Stability
Female
Histamine H1 Antagonists, Non-Sedating / blood*,  chemistry
Humans
Loratadine / administration & dosage,  analogs & derivatives,  blood*,  chemistry
Male
Molecular Structure
Piperidines / administration & dosage,  blood*,  chemistry
Pyridines / administration & dosage,  blood*,  chemistry
Reference Standards
Reproducibility of Results
Sensitivity and Specificity
Spectrometry, Fluorescence / instrumentation,  methods
Therapeutic Equivalency
Chemical
Reg. No./Substance:
0/Histamine H1 Antagonists, Non-Sedating; 0/Piperidines; 0/Pyridines; 79794-75-5/Loratadine; FVF865388R/desloratadine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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