Development and Validation of a Stability Indicating RP-UPLC Method for Simultaneous Determination of Rupatadine and Montelukast in Pharmaceutical Formulation

Navneet      Kumar; Dhanaraj      Sangeetha; Pingili      Sunil Reddy

Abstract

An accurate, precise, simple and selective stability-indicating gradient reverse phase ultra performance liquid chromatographic method has been developed and validated for the quantitative determination of rupatadine and montelukast in pharmaceutical formulation in presence of degradation products. The chromatographic separation was performed on Acquity BEH C8 column (100 mm x 2.1 mm I.D., 1.7 μm) by using mobile phase containing a gradient mixture of solvent A (0.02 M KH2PO4, pH 3.0) and B (90:10 v/v mixture of acetonitrile and water) at flow rate of 0.5 mL/min. The detection was carried out at a wavelength of 240 nm. To establish stability indicating capability of the method, drug product was subjected to the stress conditions of acid, base, oxidative, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from rupatadine and montelukast. The developed method was validated as per ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness.

Keywords: Degradation, Development, Stability-indicating, Montelukast, rupatadine, UPLC-UV, Validation, rupatadine, Acquity BEH, hydrolytic