1Department of Pharmaceutics, Nargund College of Pharmacy, Bengaluru - 85, Karnataka, India
*Corresponding Author E-mail: rama.bukka@nargund.edu.in
To develop and validate a simple, accurate, precise, and reproducible high-performance liquid chromatographic (HPLC) method for the estimation of the antiemetic drug Ondansetron hydrochloride in pharmaceutical formulations.
The chromatographic separation was carried out using a C18 column (4.6 × 250mm, 5 µm) maintained at room temperature. The mobile phase consisted of 0.1% ortho phosphoric acid and acetonitrile in a 75:25 v/v ratio, delivered in a low-pressure gradient mode at a flow rate of 1mL/min. Detection was performed using a Photo Diode Array (PDA) detector at 310nm, and the injection volume was 20 µL. The developed method was validated as per ICH guidelines for parameters such as linearity, specificity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), and robustness.
Ondansetron hydrochloride showed a well-resolved peak with a retention time of 5.4 minutes. The method exhibited excellent linearity within the concentration range of 4–28µg/mL, with high correlation coefficient values. Validation studies confirmed the method’s accuracy, precision, and robustness. The recovery values were close to 100%, and the relative standard deviation (RSD) was found to be low, indicating high reproducibility.
The developed HPLC method is accurate, precise, specific, and robust, making it suitable for the routine quantitative estimation of Ondansetron hydrochloride in pharmaceutical formulations.
Ondansetron hydrochloride, HPLC, Method validation, Linearity, Accuracy, Precision, Robustness
