Stability-indicating RP-HPLC method applied to the quantification of anti-histaminic drug ebastine in its oral suspension dosage form

Abstract

For the quantification of ebastine in pharmaceutical suspension, a simple, quick, accurate, and exact stability-indicating HPLC approach was developed and validated. The drug was determined using a phase reverse system and the separation was performed in an analytical C18 column (250 mm x 4.6 mm, 5 μm). The mobile phase consists of 0.1% orthophosphoric acid and methanol in a 25:75, v/v ratio. Using a concentration range of 10–90 μg mL^-1, the technique demonstrated a strong linear response (r=0.999). Effluents were measured at 262 nm while the flow rate was kept at 1.0 mL min^-1. There was a retention time of 3.506 min. The method was statistically validated to determine its accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity, and forced degradation assessments. The stresses that were used were acid, alkali hydrolysis, water stress, oxidation, photolysis, and heat. Since the degradation products did not affect the capacity to identify ebastine, this technique may be taken as a stability indication. This methodology may be utilized for the analysis of Ebastine in pharmaceutical suspension, since the findings obtained were within the limits set by ICH standards.