International Journal of Pharmaceutical Chemistry and Analysis 2022;9(3):125–129 Content available at: https://www.ipinnovative.com/open-access-journals International Journal of Pharmaceutical Chemistry and Analysis Journal homepage: https://www.ijpca.org/ Original Research Article Chromatographic estimation of cefetamet pivoxil in bulk and tablet dosage form: Development and validation approach Mahesh Bhanusali 1 , M. S. Palled 2, *, Shailendra S. Suryawanshi 2 1 Dept. of Pharmaceutical Chemistry, Maratha Mandal’s College of Pharmacy, Karnataka, India 2 Dept. of Pharmaceutical Chemistry, KLE College of Pharmacy, Belagavi, KLE Academy of Higher Education and Research, Belagavi, Karnataka, India ARTICLE INFO Article history: Received 02-08-2022 Accepted 07-08-2022 Available online 20-10-2022 Keywords: Cefetamet pivoxil Cephalosporin HPLC UV detection ICH guidelines ABSTRACT Cefetamet pivoxil is an oral third generation cephalosporin class of antibiotic which is mainly used in the treatment and management of both upper and lower community acquired respiratory tract infection. Many branded and generic formulations are available in tablet dosage forms in market, hence the quality control of Cefetamet pivoxil play an important role in pharmaceutical industry. In the present research work an attempt has been made to develop and validate cost effective, simple, precise, robust and rugged chromatographic method for estimation of Cefetamet pivoxil in bulk and tablets. Chromatographic method was developed using HPLC instrument. The separation was based on isocratic reverse phase chromatographic mode using C-18 column as stationary phase and mobile phase composed of acetonitrile: water (80:20 v/v) at ambient temperature using UV detection at 251 nm. Developed method was validated by analyzing parameters such as specificity, selectivity, linearity, range, precision, robustness, ruggedness, detection limit, quantification limit and drug recovery. All the method validation reportwas found to be within the acceptance as per ICH guidelines. Linearity was found between the range of 10 – 50 mg/ml. The results obtained from the validation data showed that method was specific, selective, linear, precise, accurate, robust and rugged and hence can be used for estimation of Cefetamet pivoxil in bulk and tablets dosage forms. This is an Open Access (OA) journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms. For reprints contact: reprint@ipinnovative.com 1. Introduction Cefetamet pivoxil is an oral third generation cephalosporin class of antibiotic which is mainly used in the treatment and management of both upper and lower community acquired respiratory tract infection. 1 It has an excellent antimicrobial activity against the major respiratory pathogens such as Streptococcus pneumonia, Haemophilusinfluenzae, Moraxella catarrhalis, Neisseriegonorrhoea and Enterobacteriaceae. 2 Cefetamet pivoxil is used in infection caused by susceptible micro organism found in otitis media, sinusitis, pharyngo tonsillitis, acute exacerbation of chronic bronchitis, tracheobronchitis of bacterial * Corresponding author. E-mail address: pjpalled@gmail.com (M. S. Palled). origin pneumonia, complicated and uncomplicated UTI, acute gonococcalurethretis. Many branded and generic formulations are available in market Altamet, Recocef, Bacirom O. Literature survey has been done on the analytical methods for analysis of Cefetamet pivoxil. The reviewed methods include analysis of Cefetamet pivoxil hydrochloride in drug substance and powder for oral suspension, spectrophotometric estimation of Cefetamet pivoxil in pharmaceutical formulation and reported few chromatographic methods in bulk, powders and other pharmaceutical dosage forms. 3–5 In the present analytical research, an attempt has been made to develop and validate suitable, simple, precise, robust, rugged and accurate https://doi.org/10.18231/j.ijpca.2022.023 2394-2789/© 2022 Innovative Publication, All rights reserved. 125