Analytical Method Development and Validation for the Simultaneous Estimation of Desloratadine and Montelukast by RP-HPLC Method in Bulk and Pharmaceutical Dosage Form

Shaik Anwar, G. Somashekar*
Department of Pharmaceutical Analysis, Safa College of Pharmacy, B. Thandrapadu, Kurnool, Andhra Pradesh, India

A B S T R A C T
A new, simple, precise, accurate and reproducible RP-HPLC method for Simultaneous estimation of Desloratadine and Montelukast in bulk and pharmaceutical formulations. Separation of Desloratadine and Montelukast was successfully achieved on a ECLEPSE XDB C8 (4.6 x 150mm, 5 mm, Make: Waters) or equivalent in an isocratic mode utilizing K₂HPO₄ buffer (P^H: 8.6) Methanol (60:40%v/v) at a flow rate of 0.8 mL/min and elute was monitored at 261 nm, with a retention time of 2.485 and 3.800 minutes for Desloratadine and Montelukast. The method was validated and the response was found to be linear in the drug concentration range of 50 µg/mL to 150 µg/mL for Desloratadine and 50 µg/mL to 150µg/mL for Montelukast. The LOD and LOQ for Desloratadine were found to be 2.759, 9.195 respectively. The LOD and LOQ for Montelukast were found to be 2.9091, 9.6970 respectively. This method was found to be good percentage recovery for Desloratadine and Montelukast were found to be 100.00% and 100.00% respectively indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Range, Accuacy, Precesion, Specificity and Robustness.
Keywords: Desloratadine, Montelukast, High performance liquid chromatography.