The aim of the present study was the development and validation of a simple, precise and specific RP-HPLC method for assay of montelukast (MNT) and rupatadine (RPT) in tablet dosage forms. The separation was achieved on Grace C-18 Column (4.6 × 250 mm, 5 μm) using acetonitrile and 0.05% OPA (60:40, v/v) as mobile phase for assay and flow rate 1 ml/ min and detection was carried out in U.V detector at 242.0 nm. The retention time of RPT and MNT were found to be 3.86 min and 7.60 min respectively. The linearity of the RPT and MNT was found over the range of 5-25 μg/ml. The system suitability test shows the response with retention time, theoretical plate, tailing factor and peak area for both the drugs. The validation of method carried out using ICH guidelines. The developed method was gave good resolution for drugs. The developed RP-HPLC method can be applied for routine quantitative and qualitative analysis of RPT and MNT in bulk and pharmaceutical formulations like tablets.
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