Method Development and Validation for Simultaneous Estimation of Montelukast Sodium and Desloratadine by RP-HPLC

Abstract

A novel, precise, accurate, rapid and cost effective isocratic reverse-phase high performance liquid chromatographic (RP-HPLC) method was developed, optimized and validated for the simultaneous estimation of Montelukast Sodium (MON) and Desloratadine (DES) in pharmaceutical dosage forms. The drugs were estimated using Hypersil BDS C18 (250 mm × 4.6 mm I.D., 5 μ particle size) column. The mobile phase composed of orthophosphoric acid and water in the ratio of 20:80 v/v, at a flow rate of 1.0 ml/min was used for the separation. Detection was carried out at 280 nm. The linearity range obtained was 10 - 30 μg/ml for MON and 5 - 15 μg/ml for DES with retention times of 2.929 min and 4.439 min for MON and DES respectively. The correlation coefficient values were found to be 0.999. Precision studies showed % RSD values less than 2% for both the drugs in all the selected concentrations. The percentage recoveries of MON and DES were in the range of 99.59% - 99.82% and 99.60% - 99.80% respectively. The limit of detection (LOD) and limit of quantification (LOQ) were 0.176 μg/ml, 0.587 μg/ml for MON and 0.087 μg/ml, 0.292 μg/ml for DES respectively. The method was validated as per the International Conference on Harmonization (ICH) guidelines. The proposed validated method was successfully used for the quantitative analysis of commercially available tablet dosage forms.