RP HPLC Enabled Novel Analytical Method for the Development and Quantification of Cefuroxime Axetil in its Bulk Drug and Pharmaceutical Formulations

Current investigations aim to develop and validate an accurate, simple, specific, and precise RP-HPLC method for the detection of cefuroxime axetil, in bulk and tablet dosage forms. Despite extensive literature reviews, no method could be found for estimating the variables mentioned above. The chromatographic separation is achieved on Sunfire C18 column (250 mm × 4.6 mm, 5 µm) of HPLC (Agilent Tech 1100), with 5 µm mobile phase composed of methanol, orthophosphoric acid (0.05%) adjusted to a pH of 3.0 in water, 40:60% v/v triethylamine using isocratic mode of elution, at wavelength 278.0 nm using UV Spectrophotometer, temperature 25 °C, detection is done. The developed method is done as per ICH guidelines. A linear calibration curve is found to be linear in concentrations between 1 and 5 µg mL−1 (r2 = 0.9995). The percentage recoveries of cefuroxime axetil are found to be in the range of 95.68–96.98%. The percentage of relative standard deviations in intraday trials is found to be 0.61, 0.66, and 0.88, respectively, and in interday studies are 0.06, 0.16, and 0.29, respectively, demonstrating good accuracy and little variance. The proposed method is highly sensitive, robust, precise, accurate, and the use of green solvents makes this method safe and efficacious. © 2024 Wiley-VCH GmbH.