PRATHAMESH SHIROLE, DHANASHREE P SANAP, KİSAN JADHAV
Acta Pharmaceutica Sciencia - 2025;63(1):134-151
To determine ondansetron hydrochloride in bulk drug, an easy, fast, sensitive, and discerning stability-indicating (RP-HPLC) approach is proposed. Ondansetron hydrochloride was eluted from C18 column (4.6 × 250 mm, 5 µm) and mobile phase containing methanol, acetonitrile and water (50: 30: 20 v/v/v). According to ICH Q2 (R1) guidelines, the entire analytical technique validation was completed. The results of the retrieval study, which was conducted at working concentration levels between 80 to 120%, ranged from 99% to 101%. With a linear regression curve (R2=0.9941), the linearity was assessed in the working concentration range of 5-35 μg mL-1, with a limit of quantitation (LOQ) and detection (LOD) of 0.2559 μg mL-1 and 0.7755 μg mL-1, respectively. Ondansetron hydrochloride showed a retention time of 4.997 min. The approach exhibited good recovery with relative standard deviations under 2% for intra and inter-day precision.
