Abstract
DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD FOR DETERMINATION OF DESLORATADINE IN TABLET DOSAGE FORM

Prajakta R. Raut, Padmanabh B. Deshpande* and Prachi Karwa

ABSTRACT

The present work describes development and validation of a new simple, accurate and precise stability-indicating high performance thin layer chromatographic (HPTLC) method for determination of Desloratadine as bulk drug and in tablet dosage form. As stability testing is key step in the development of new drug as well as formulation, stress degradation studies were carried out according to ICH guidelines. Desloratadine was found susceptible to all the analyzed stress conditions. HPTLC plates precoated with silica gel 60 F254 were used as the stationary phase and chromatographic separation was achieved by using Methanol: Benzene: Acetic acid (6: 4: 0.5, v/v/v) as mobile phase. Densitometric detection was carried out at 242 nm. The retention factor was found to be 0.55 ± 0.05. The developed method was validated with respect to linearity, accuracy, precision, limit of detection, limit of quantitation and robustness as per ICH guidelines. The developed method was found to be linear in the concentration range of 200-1000 ng band-1. The LOD and LOQ for Desloratadine was found to be 31.47 ng band-1 and 95.37 ng band-1, respectively. The developed method has been effectively applied for the drug estimation in tablet dosage form.

Keywords: Desloratadine, Stability indicating method, HPTLC, Forced degradation studies.


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