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Curr Drug Metab. 2019 Nov 24. doi: 10.2174/1389200220666191125095648. [Epub ahead of print]

Developing A High-performance Liquid Chromatography Method for Simultaneous Determination of Loratadine and its Metabolite Desloratadine in Human Plasma.

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1
Department of mathematical and physical sciences, University of Chester, Chester CH2 4NU, United Kingdom.

Abstract

BACKGROUND:

Allergic diseases are considered among the major burdons of public health with increased prevalence globally. Histamine H1-receptor antagonists are the foremost commonly used drugs in the treatment of allergic disorders. Our target drug is one of this class, loratadine and its biometabolite desloratadine which is also a non sedating H1 receptor antagonist with anti-histaminic action of 2.5 to 4 times greater than loratadine. To develop and validate a novel isocratic reversed-phase high performance liquid chromatography (RP-HPLC) method for rapid and simultaneous separation and determination of loratadine and its metabolite, desloratadine in human plasma.

METHODS:

The drug extraction method from plasma was based on protein precipitation technique. The separation was carried out on a Thermo Scientific BDS Hypersil C18 column (5µm, 250 x 4.60 mm) using a mobile phase of MeOH : 0.025M KH2PO4 adjusted to pH 3.50 using orthophosphoric acid (85 : 15, v/v) at ambient temperature. The flow rate was maintained at 1 mL/min and maximum absorption was measured using PDA detector at 248 nm.

RESULTS:

The retention times of loratadine and desloratadine in plasma samples were recorded to be 4.10 and 5.08 minutes respectively, indicating a short analysis time. Limits of detection were found to be 1.80 and 1.97 ng/mL for loratadine and desloratadine, respectively, showing a high degree of method sensitivity. The method was then validated according to FDA guidelines for the determination of the two analytes in human plasma.

CONCLUSION:

The results obtained indicate that the proposed method is rapid, sensitive in the nanogram range, accurate, selective, robust and reproducible compared to other reported methods.

KEYWORDS:

Desloratadine; FDA guidelines; Human plasma; Loratadine; Protein precipitation; RP-HPLC

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