Author(s): Shanta K Adiki*, Baishakhi Dey, Nureddin AA Arebi, Fauzi El Melad, Prakash Katakam, Babu Rao Chandu
The current research paper reports a validated UV and RP-HPLC method for routine estimations of CFTX in bulk and unit dosage formulations. For the UV estimation of CFTX, using ammonium acetate buffer as the solvent, λmax was set at 241.5 nm and linearity range obtained in the concentration range of 2-10 µg/mL. The optimized RP-HPLC conditions for CFTX estimation were obtained with isocratic separation mode in a C18 inertsil column (150 mm × 4.6 mm, 3 μm) using a degassed mixture of buffer: methanol in the ratio of 74:26, injection volume (20 µL), flow rate (1 mL/min) and run time (20 minutes), at ambient column temperature with UV detector set at 254 nm. The linearity of the method was demonstrated over the concentration range of 80-120 µg/mL. The percent assay of CFTX determined by UV and RP-HPLC method were 99.8 ± 0.001 and 101.5 ± 0.001 respectively. The recovery CFTX determined by UV and RP-HPLC were 99.6-99.8 % and 101.1 % respectively with % RSD values of peak areas 0.2 and 0.3 respectively. Values of all other parameters of method validations in both methodologies were within the acceptance limits.