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J Pharm Bioallied Sci. 2013 Jan;5(1):74-9. doi: 10.4103/0975-7406.106571.

Development and validation of an improved LC-MS/MS method for the quantification of desloratadine and its metabolite in human plasma using deutrated desloratadine as internal standard.

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  • 1Department of Pharmaceutical Chemistry, Seemanta Institute of Pharmaceutical Sciences, Orissa, India.

Abstract

PURPOSE:

For the determination of desloratadine (DES) and 3-OH desloratadine (3-OHD) in human plasma using deutrated desloratadine (DESD5) as internal standard (IS), a novel stability indicating liquid chromatography-tandem mass spectrometric method was developed and validated to support the clinical advancement.

MATERIALS AND METHODS:

The solid-phase extraction method used for sample preparation and calibration range was 100-11,000 pg/ml, for which a quadratic regression (1/x(2)) was best fitted. The blank plasma was screened and observed free from any endogenous interference.

RESULTS:

The accuracy (% nominal) at low limit of quantification LLOQ level for DES and 3-OHD was 100.4% and 99.9% whereas precision (%CV) was 4.6 and 5.1%. They (DES and 3-OHD) were stable in human plasma after five freeze-thaw cycles, at room temperature for 23.8 hour, bench top stability for 6.4 hour.

CONCLUSION:

This method fulfills all the regulatory requirements for selectivity, sensitivity, precision, accuracy, stability, goodness of fit, and ruggedness of the method for the determination of DES and 3-OHD in human plasma.

KEYWORDS:

3-OH desloratadine; Desloratadine; method validation

PMID:
23559828
PMCID:
PMC3612343
DOI:
10.4103/0975-7406.106571
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