Validation and Application of a Modified RP-HPLC Method for the Quantification of Desloratadine in Pharmaceutical Dosage Forms

Abstract

ABSTRACT:The purpose of the study was to develop a simple, sensitive and rapid RP-HPLC method for the determination of desloratadine in marketed products. Chromatographic determination was performed in a reverse phase C 18 column (250 mm × 3.3 mm I.D. , 5µm particle size) using a mixture of acetonitrile ‫׃‬ n-pentane sulphonic acid sodium salt monohydrate, adjusted to pH 3.0± 0.05 with phosphoric acid ‫׃06(‬ 40 v/v) as mobile phase and delivered at a flow rate of 1 ml/min. The UV detection was set at 254 nm. The calibration range was from 2.0 to 40 µg/ml. The method was validated in term of linearity (r 2 >0.98, RSD= 1.958%), precision (RSD=3.757 %) and accuracy (deviation<2.653%, RSD< 2.203%). The limit of quantification was 2 µg/ml and the limit of detection was 0.1 µg/ml. The linear ranges of desloratadine were 20.23 ± 0.368 µg/ml and 6.545 ± 0.0495 µg/ml in tablet (potency = 99.175 ± 0.718 %) and syrup (potency = 101.15 ± 1.838 %) respectively. The potency of desloratadine in marketed products was determined by this method with acceptable precision and reproducibility.

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“…Desloratadine is chemically 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-5H-benzo [5,6] cyclohepta [1,2-b] pyridine is a antihistaminic drug. Desloratadine is an non-sedative antihistaminic drug with selective H1receptor antagonist activity.…”

“…Desloratadine is used for relieving the symptoms of allergic rhinitis, pruritus and urticaria. Literature survey reveals that desloratadine alone and in combination with other drugs can be estimated by spectroscopic methods [1][2][3] and RP-HPLC [4][5][6][7]. The chemical structure of desloratadine is shown in the Figure. It is used to treat chronic inflammatory pulmonary conditions, tracheobronchitis, emphysema and asthma.…”

A validated stability-indicating UPLC method for desloratadine and its impurities in pharmaceutical dosage forms

“…The assay method [1] reported describes the separation of degradation impurities from deslaratadine formed through forced degradation studies, but it was out of scope because it did not separate and determine the impurities. A validated RP-HPLC method has been reported for quantification of desloratadine in pharmaceutical forms [2], a spectophotometric, spectrofluorometric and HPLC method has been reported for determination desloratadine in dosage forms and in human plasma [3] and a LC method has been reported for simultaneous determination of loratadine and desloratadine in pharmaceutical preparations using micro-emulsion as eluent [4], but forced degradation study and impurity details were not reported in these articles [2][3][4]. We have developed a stability-indicating RP-LC method that can separate and determine deslaratadine and its five impurities namely imp-A, imp-B, imp-C, imp-D and imp-E (Fig.…”