Abstract

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DESLORATADINE AND MONTELUKAST SODIUM BY RP-HPLC

R. Naga Kishore*, N. Anjaneyulu1, A. Teja Sri, B. Vani swetha and M. Bhavani

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 Desloratadine and Montelukast Sodium in pharmaceutical dosage forms. The drugs were estimated using Imp Sil,C18HS(250 mm x 4.6 mm i.d, 5m)column. The mobile phase composed of Acetonitrile, Methanol, water with ratio of 15:80:05 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 2-10 μg/ml for Desloratadine and 10 – 50 μg/ml for Montelukast with retention times of 2.46 min and 3.73 min for Desloratadine and Montelukast respectively. The correlation coefficient values were found to be 0.9994 and 0.9998. Precision studies showed % RSD values less than 2% for both the drugs in all the selected concentrations. The percentage recoveries of Desloratadine and Montelukast were in the range of 99.32% - 99.58% and 99.38%- 109% respectively. The limit of detection (LOD) and limit of quantification (LOQ) were 0.522μg/ml, 0.584μg/ml for Desloratadine and 1.384μg/ml 1.268μg/ml for Montelukast 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.

Keywords: Montelukast Sodium, Desloratadine, HPLC, Validation.