Research Article A Validated RP-HPLC Method for Simultaneous Determination of Cefixime and Clavulanic Acid Powder in Pediatric Oral Suspension Utsav Nepal , 1,2 Vijay Kumar Panthi , 3,4,5,6 Namindra Prasad Chaudhary, 2,7 and Samip Chaudhary 2,8 1 Department of Pharmacy, Kathmandu University, School of Science, Dhulikhel, Nepal 2 Quality Control Department, Royal Sasa Nepal Pharmaceuticals, Bharatpur-18 44200, Chitwan, Nepal 3 Research and Development Department, Royal Sasa Nepal Pharmaceuticals, Bharatpur-18 44200, Chitwan, Nepal 4 Department of Pharmacy, Tribhuvan University, Sunsari Technical College, Sunsari, Nepal 5 Research and Development Department, Asian Pharmaceuticals, Rupandehi, Nepal 6 Research and Development Department, Corel Pharmaceuticals, Rupandehi, Nepal 7 Kantipur College of Medical Science, Tribhuvan University, Sitapaila, Kathmandu, Nepal 8 Tri-Chandra Multiple Campus, Tribhuvan University, Kathmandu, Nepal Correspondence should be addressed to Vijay Kumar Panthi; nepalivijay7@gmail.com Received 24 February 2022; Revised 7 June 2022; Accepted 9 June 2022; Published 1 July 2022 Academic Editor: Mohamed Abdel-Rehim Copyright © 2022 Utsav Nepal et al. is is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. A new reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the si- multaneous estimation of pediatric oral powder formulation containing cefixime (CFX) and clavulanic acid (CVA). In this research, an analytical C18 (4.6 mm × 25 cm), 5 μm column was used for chromatographic separation with a mixture of methanol and water containing disodium hydrogen phosphate in ratio of 20 : 80 v/v as the mobile phase (pH 5.5 adjusted with ortho- phosphoric acid) at a flow rate of 1.0 mL/min. e detecting wavelength and run time were 220 nm and 15 min, respectively. Moreover, the column temperature was maintained at 30 ° C. e analytical method was validated prior to meeting the conditions specified by International Conference on Harmonization (ICH) and the parameters were specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision, robustness, and solution stability. e calibration curve was found to be linear between the concentration ranges of 0.024–0.036 mg/mL and 0.032–0.048 mg/mL for CFX and CVA, respectively. Furthermore, the LOD and LOQ of CFX were 0.0008 and 0.0025 μg/mL, respectively. Accordingly, LOD and LOQ of CVA were 0.0021 and 0.0065 μg/mL, respectively. e accuracy of the optimized method was examined by recovery studies and the mean recovery was observed to be 98.96% and 99.05% for CFX and CVA, respectively, at 100% spiked level. e repeatability testing for both standard and sample solutions revealed that the method is precise within the acceptable range and the %RSD of the precision was <2%. In addition, the findings of specificity, linearity, accuracy, precision, robustness, LOD, LOQ, and solution stability studies of both CFX and CVA were within the criteria of acceptable limit as well. 1. Introduction Cephalosporins are antimicrobial agents that belong to the beta-lactam class which are broadly used to treat several infections caused by Gram-positive and Gram-negative bacteria. Cephalosporins are categorized into five genera- tions according to their range of spectrum against these bacteria [1]. e third-generation cephalosporins are widely applied for the treatment of several types of infections in children. Currently, cefixime (CFX) is the only third-gen- eration cephalosporin for oral delivery in Canada, and the license was approved in 1990. e gastrointestinal absorp- tion of CFX is incomplete, approximately 40–50% is absorbed, and the oral suspension is completely absorbed in a rapid manner in comparison with tablets [2]. e rec- ommended oral dosage for children is 8 mg/kg once a day or Hindawi International Journal of Analytical Chemistry Volume 2022, Article ID 8331762, 10 pages https://doi.org/10.1155/2022/8331762