Stability Indicating RP-HPLC Method for Simultaneous Estimation of Rupatadine Fumarate and Montelukast Sodium in Bulk and Tablet Dosage Form

A simple, selective, accurate and sensitive high performance liquid chromatography (HPLC) method was developed and validated for the simultaneous determination of rupatadine fumarate (RPT) and montelukast sodium (MNT). Chromatographic separation achieved isocratically on a Hypersil BDS C-8 (250 mm x 4.6 mm, 5 mu m) column utilizing a mobile phase of methanol: acetonitrile: buffer (40 : 30 : 30), (pH 3 with H3PO4) at a flow rate of 1.0 mL/min and column oven temperature 40 degrees C with UV detection at 270 nm. Statistical analysis proves that the method is reproducible and selective for the simultaneous estimation of RPT and MNT. As the method could effectively separate the drugs from their degradation products, it can be employed as stability indicating method. The developed method was validated as per ICH guidelines in terms of accuracy, precision, linearity and specificity.