Development and Validation of a Reversed-Phase HPLC Method for Simultaneous Estimation of Rupatadine Fumarate and Montelukast Sodium from Their Combined Dosage Forms

Abstract

A simple, accurate, precise and rapid reversed-phase high performance liquid chromatographic (RPHPLC) method has been developed and subsequently validated for the simultaneous estimation of
Rupatadine Fumarate and Montelukast Sodium from their combination drug product. The proposed
method is based on the separation of the two drugs in reversed-phase mode using Symmetry C-8
analytical column (150 x 4.6 mm; 5 µ). The optimum mobile phase consisted of acetonitrile:
phosphate buffer pH 4.7 adjusted with o-phosphoric acid (60:40, v/v), mobile phase flow rate of 1.2
mL min-1 and UV detection was set at 254 nm. The retention times were 3.22 and 10.67 min. for
Rupatadine Fumarate and Montelukast Sodium, respectively. The method was validated according to
ICH guidelines. It was found to be accurate and reproducible. Linearity was obtained in the
concentration range of 100-300 µg mL-1 for both Rupatadine Fumarate and Montelukast Sodium with
correlation coefficients of 0.999 and 0.999 respectively. Mean percent recovery of triplicate samples at
each level for both drugs were found in the range of 98.7% to 99.5% with RSD of less than 2.0%. The
proposed method can be successfully applied in the quality control of bulk manufacturing and
pharmaceutical dosage forms.