Stability indicating RP-HPLC method development and validation of cefepime and amikacin in pure and pharmaceutical dosage forms

Abstract

A simple, accurate, isocratic stability indicating RP-HPLC method was developed for the determination of cefepime and amikacin in Pure and its pharmaceutical formulations. The method consists of methanol: acetonitrile:acetate buffer 75:20:05 (v/v) mobile phase at pH 5.1 with C18 column as stationary phase. The flow rate and detection wave length were 1.0 mL/min and 212 nm respectively. The linearity range for the method was found to be 2.5-25 µg/mL for amikacin and 10-100 µg/mL cefepime respectively. The developed method was validated as per ICH guidelines and the results of all the validation parameters were well within their acceptance values. Also the forced degradation studies were conducted with standard drugs. Degradation products formed during the different stress conditions were separated from both drugs. This validated method was applied for the simultaneous estimation of cefepime and amikacin in commercially available formulation sample.

Analytical methods for the determination of certain antibiotics used in critically ill patients

“…RP-HPLC method was described for the quantification of Cefepime and amikacin in Pure and pharmaceutical formulations. This method was carried out on C18 (250 mm × 4.6 mm, 5 µm) column using a mobile phase consists of methanol: acetonitrile: acetate buffer 75:20:05 (v/v) at pH 5.1 with flow rate 1 ml/min and detection wave length was 212 nm [15] .…”

Stability indicating UPLC-MS/MS method for quantification and identification of cefepime and its degradants in API

“…It is used to treat urinary tract infections, septicemia, staphylococcal infections, bronchitis, intra-abdominal infections, skin and its structures infections, pneumonia infections, and in febrile neutropenic patients (Glish and Burinsky, 2008;Lemke et al, 2002). CFP stability was estimated using several methods using chromatography (Abd El Aziz Shama et al, 2021;Al Kamaly, 2022;Bjergum et al, 2021;De Borba et al, 2008;Dos Anjos et al, 2022;El-Beltagy et al, 2019;El-Dars et al, 2019;Fage et al, 2021;Isla et al, 2005;Jagadeesh Kumar et al, 2010;Jiang et al, 2010;Jiménez Palacios et al, 2005;Kalyani et al, 2018;Kommana et al, 2014;Liu et al, 2018;Mameli et al, 2019;Moorthy et al, 2020;Nemutlu et al, 2009, Ocaña González et al, 2004Ohmori et al, 2011;Patil et al, 2018;Rehm and Rentsch, 2020;Rodrigues et al, 2016;Seraisso et al, 2022;Shrestha et al, 2014;Siddiqui et al, 2010;Sun et al, 2022;Sundara Raj et al, 2013;Sunitha et al, 2013;Van Vooren and Verstraete, 2021;Zander et al, 2015) but these methods had some disadvantages as complex mobile phase composition, increased matrix effect, decreased sensitivity, and inability to identify degradants using trace analysis in addition to fragmentation (Niessen, 2010;Niessen and Ricardo, 2017), less environmentally friendly, and time-consuming. However, there have been no previous analytical procedures of trace analysis reported on CFP stability studi...…”

Spectroscopic Estimation of Cefepime by using Batch, Cloud Point extraction and Flow Injection Analysis methods

“…Cefepime chemically 7--(2-aminothiazol-4-yl)-(z)methoxyiminoacetamido]-3-(1methylpyrrolidino)-methyl-3-cephem-4-carboxylate [1], as shown in figure 1. CFM is a third-generation cephalosporin bactericidal activity spectrum in vivoandin vitroagainstaerobic gram-negative and gram-positive micro-organisms [2,3], including penicillin resins, For the analysis of Tazo-bactam (TZB) in pharmaceutical preparations [4,5] and plasma [6] either alone or in combination with other products, various analytical methods such as spectrophotometry [7,8]HPLC8 [9] TLC [10] exist for the analysis of cefepime (CFM) and similarly different HPLC methods are available.…”