Sensitive LC-MS/MS-ESI method for simultaneous determination of montelukast and fexofenadine in human plasma: application to a bioequivalence study
| Autor: | Rajendraprasad, Muppavarapu, Swati, Guttikar, Manavalan, Rajappan, Kannan, Kamarajan, Ramesh, Mullangi |
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| Rok vydání: | 2013 |
| Předmět: |
Adult
Cyclopropanes Male Spectrometry Mass Electrospray Ionization Cross-Over Studies Reproducibility of Results Acetates Sulfides Sensitivity and Specificity Drug Stability Therapeutic Equivalency Tandem Mass Spectrometry Linear Models Quinolines Humans Single-Blind Method Terfenadine Chromatography High Pressure Liquid |
| Zdroj: | Biomedical chromatography : BMC. 28(8) |
| ISSN: | 1099-0801 |
| Popis: | A rapid, simple, sensitive and selective LC-MS/MS method was developed and validated for simultaneous quantification of montelukast (MT) and fexofenadine (FF) in human plasma (200 μL) using montelukast-d6 (MT-d6 ) and fexofenadine-d10 (FF-d10 ), respectively as an internal standard (IS) as per the US Food and Drug Administration guidelines. The chromatographic resolution was achieved on a Chromolith RP18e column using an isocratic mobile phase consisting of 20 mm ammonium formate-acetonitrile (20:80, v/v) at flow rate of 1.2 mL/min. The LC-MS/MS was operated under the multiple-reaction monitoring mode using electrospray ionization. The total run time of analysis was 4 min and elution of MT, FF, MT-d6 and FF-d10 occurred at 2.5, 1.2, 2.4 and 1.2 min, respectively. The standard curve found to be linear in the range 2.00-1000 ng/mL with a coefficient of correlation of ≥0.99 for both the drugs. The intra- and inter-day accuracy and precision values for MT and FF met the acceptance as per FDA guidelines. MT and FF were found to be stable in a battery of stability studies viz., bench-top, auto-sampler and repeated freeze-thaw cycles. The validated assay was applied to an oral bioequivalence study in humans. |
| Databáze: | OpenAIRE |
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