Validated RP-HPLC Method for the Estimation of Rupatadine fumarate in Bulk and Tablet Dosage Form | Abstract

Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry

ISSN: 0975-413X
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Validated RP-HPLC Method for the Estimation of Rupatadine fumarate in Bulk and Tablet Dosage Form

Author(s): Rupali L.Choudekar, M. P. Mahajan, S. D. Sawant

A novel, simple and economic reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the estimation of Rupatadine fumarate in bulk and tablet dosage form with greater precision and accuracy. Separation was achieved on C18 column (250X4.6mm i.d.,5μm) in isocratic mode using Acetonitrile:Methanol:Water in the ratio of 40:50:10 (v/v/v) as mobile phase, pumped in to the column at flow rate of 1.0 mL min−1 and the detection of eluent from the column was carried out using variable wavelength UV detector at 244 nm. The total run time was 10 min and the column was maintained at ambient temperature. The retention time of Rupatadine fumarate was 7.350 min. The standard curves were linear over the concentration range of 10-60 μg mL−1 with R2 9996 and the LOD and LOQ values for Rupatadine fumarate were 0.026 μg mL−1 and 0.056 μg mL−1 respectively. The percentage recovery was found to be 99.06 to 100.60, the % RSD of intraday and inter day precision was found to be 0.68 and 0.61, respectively. The percentage amount of a marketed tablet formulation of Rupatadine fumarate was found to be 99.08 %. The method was validated as per ICH guidelines. Validation studies demonstrated that the proposed RP-HPLC method is simple, specific, rapid, reliable and reproducible. Hence the proposed method can be applied for the routine quality control analysis of Rupatadine fumarate in bulk and tablet dosage forms.


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