Development and Validation of RP-HPLC-UV Method for Simultaneous estimation of Rupatadine and Montelukast in Bulk and its Tablets

ABOUT AUTHOR
R. Vani*, B. Vijaya Kumar, G. Krishna Mohan
Research Scholar, Jawaharlal Nehru Technological University Kakinada, Kakinada, A. P. India.
Jangaon Institute of Pharmaceutical Sciences, Jangaon, Warangal Dist., A. P. India.
Centre for Pharmaceutical Sciences, IST, JNTU Hyderabad, A.P. India

Abstract
A simple, selective, linear, precise, and accurate RP-HPLC method was developed and validated for the simultaneous estimation of Rupatadine and Montelukast from bulk and formulations. Chromatographic separation was achieved isocratically on a Waters C18 column (250×4.6 mm, 5 µ particle size) using a mobile phase, (Methanol: Phosphate buffer pH adjusted to 3.0 with orthophosphoric acid in the ratio of 70:30 v/v. The flow rate was 1 ml/min and effluent was detected at 245 nm and 20μl of sample was injected. The retention time of Rupatadine and Montelukast were 2.3 and 3.9 min respectively. Linearity was observed in the concentration range of 50-150 µg/ml for Montelukast and Rupatadine. Percent recoveries obtained for both the drugs were 100.00-101.00%. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision, LOD and LOQ. The method developed was successfully applied for the analysis of simultaneous estimation of Rupatadine and Montelukast tablets.
Key words:Rupatadine, Montelukast, Methanol, Phosphate buffer, orthophosphoric acid