STABILITY INDICATING RP-UPLC METHOD DEVELOPMENT AND VALIDATION OF EBASTINE & MONTELUKAST IN TABLET DOSAGE FORM

Anamika B Kakad , Dr. Sagar Tambe , Dr. Kuldeep Ramteke , Radhika Katpale , Aishwarya Jadhav

doi:10.7492/txyjh781

Authors

Anamika B Kakad , Dr. Sagar Tambe , Dr. Kuldeep Ramteke , Radhika Katpale , Aishwarya Jadhav Author

DOI:

https://doi.org/10.7492/txyjh781

Keywords:

RP-UPLC, Stability-indicating method, Ebastine, Montelukast, Method validation, Forced degradation, Tablet dosage form, ICH guidelines

Abstract

A robust, rapid, and stability-indicating reverse-phase ultra-performance liquid chromatographic (RP-UPLC) method was developed and validated for the
simultaneous quantification of Ebastine and Montelukast in tablet dosage forms. Chromatographic separation was achieved on a suitable UPLC column using a
gradient/optimized isocratic mobile phase composed of aqueous buffer and organic solvent, delivered at a controlled flow rate. Detection was carried out using a
UV/PDA detector at an optimized wavelength, providing well-resolved, symmetrical peaks with short retention times for both analytes. . The developed RP-UPLC
method is simple, fast, reliable, and suitable for routine quality control analysis as well as stability testing of combined tablet formulations containing Ebastine and
Montelukast.