Development and Validation of Stability Indicating Related Substances Method for Montelukast Sodium and Levocetirizine Dihydrochloride Combined Tablets by RP-HPLC

In this paper authors presented the development and validation of RP-HPLC method for determination of related substances present in Montelukast sodium and Levocetirizine dihydrochloride combined tablets. Chromatographic separation was achieved on Hypersil ODS (150 x 4.6 mm),5 µ column with flow rate 1 mL/min, detection wavelength 238 nm, injection volume 10 µL, column temperature 40°C and run time 75 mins. Gradient programming was used with mobile phase-A (MP-A)-50mM acetate buffer pH 5.5 and mobile phase-B(MP-B)-methanol: MP-A (90:10 %v/v). Developed method was validated as per ICH Q2(R1) guideline. As the method was able to analyse forced degradation samples successfully, it proved to be stability-indicating.