Sri Lakshmi D*1, Jane T Jacob2, Srinivaas Sastry D
1Department of Pharmaceutical Chemistry, Aditya Pharmacy College, Surampalem, Andhra Pradesh India.
2Nitte University, NGSMIPS, Department of Pharmaceutical chemistry, Mangalore, Karnataka, India.
A B S T R A C T
The aim of this work was focused on to develop and validate accurate, simple reverse phase high-performance liquid chromatography method for simultaneous estimation of olopatadine and montelukast in pharmaceutical dosage form. The chromatographic separation was performed on Agilent Eclipse XDB-C18 (4.6 x 150mm, 5.0µm), with a mobile phase comprising of a mixture phosphate buffer and Acetonitrile (20:80) at flow rate of 1mL/min with detection wavelength at 270 nm. Retention times of olopatadine and montelukast were found to be 2.7 minutes and 3.5 minutes respectively. The developed method was validated according to ICH guidelines, linearity of olopatadine was found to be in the range of 20-100 μg/mL and that of montelukast was found to be in the range of 40-200 μg/mL. The percentage recoveries for both drugs were found in the range of 100-101%. The limit of detection and the limit of quantification values for olopatadine were found to be 2.98 and 9.97 and that for montelukast were found to be 2.97 and 9.98 respectively.
Keywords: Olopatadine, Montelukast, Reverse phase high performance liquid chromatography, Validation, Degaradation.