Rp-Hplc Method Development and Validation for...

Rp-Hplc Method Development and Validation for the Estimation of Topiroxostat in Pure and Pharmaceutical Dosage Form

Author Name : Dr. S. Naazneen

DOI: https://doi.org/10.56025/IJARESM.2024.1209242323

ABSTRACT An accurate, sensitive, precise, fast isocratic reverse phase HPLC technique has been developed and validated for the quantification of Topiroxostat in the pure and pharmaceutical dosage form. The best separation was achieved on a 250 mm x 4.6 mm ID., 5µ-particle size Inertsil®-Octadecyl-Silyl-3V-Reverse-Phase-C18-column with 0.02M Dipotassium hydrogen Orthophosphate in water pH:2.5 with Orthophosphoric acid:Acetonitrile (60:40 v/ v) as mobile phase solvent at a flow rate of 0.8 ml/ min in the isocratic mode of elution. UV detection was observed at 210 nm. Retention time of Topiroxostat was found to be 4.3 minutes. With a correlation coefficient of about 0.9982, peak-response was obtained as function of concentration of Topiroxostat over the range of 80 to 240 µg/ ml. Topiroxostat had shown to have a percentage assay of 109.97 %. It had a limit of detection (LOD) and a limit of quantification (LOQ) of 0.2 µg/ ml and 0.6 µg/ ml, respectively. The presence of excipients in the formulation had no effect on the assay method. The procedure is swift and precise and can be employed appropriately for use in QC- laboratories.