title: 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.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pharmaceutical Chemistry, Seemanta Institute of Pharmaceutical Sciences, Orissa, India.
authors.forename: M Saquib
authors.initials: MS
authors.lastname: Hasnain
authors.forename: Shireen
authors.initials: S
authors.lastname: Rao
authors.forename: Manoj Kr
authors.initials: MK
authors.lastname: Singh
authors.forename: Nitin
authors.initials: N
authors.lastname: Vig
authors.forename: Manish Kr
authors.initials: MK
authors.lastname: Singh
authors.forename: Subodh Kr
authors.initials: SK
authors.lastname: Budakoti
authors.forename: Abdulla
authors.initials: A
authors.lastname: Ansari
keywords: 3-OH desloratadine; Desloratadine; method validation
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