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.
Highlights
Cefepime is a broad-spectrum cephalosporin antibiotic with greater activity against both gram-negative and gram-positive organisms than third-generation agents (Ahavet al., 2007; Chapman, Perry, 2003)
Chemical name of the amikacin is (2S)-4-amino-N[(1R,2S,3S,4R,5S)-5-amino-2-[(2S,3R,4S,5S,6R)-4amino-3,5-dihydroxy-6-(hydroxyl methyl)oxan-2-yl] oxy-4-[(2R,3R,4S,5S,6R)-6-(aminomethyl)-3,4,5trihydroxyoxan-2-yl]oxy-3-hydroxycyclohexyl]2-hydroxybutanamide – Figure 1b (ChemicalStructure.34635.htmL). It is a semi-synthetic drug derived from kanamycin A with multidrug-resistant Gram-negative bacteria such as Pseudomonas aeruginosa, Acinetobacter, and Enterobacter (Grassi, Grassi, 1993; Tally et al, 1975; Brewer, 1977)
After optimizing several conditions for determination of cefepime and amikacin mobile phase consisting of Methanol: Acetonitrile: Acetate Buffer 75:20:05 (v/v) at pH 5.1 was found to be satisfactory
Summary
Cefepime is a broad-spectrum cephalosporin antibiotic with greater activity against both gram-negative and gram-positive organisms than third-generation agents (Ahavet al., 2007; Chapman, Perry, 2003). Chemical name of the cefepime is (6R,7R)-7-[[(2Z)-2-(2-amino1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[(1methyl pyrrolidin-1-ium-1-yl) methyl]-8-oxo-5-thia-1azabicyclo[4.2.0]oct-2-ene-2-carboxylate – Figure 1a (http://www.chemspider.com) It is a fourth-generation antibiotic used for treatment of pneumonia (moderate to severe) caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species. A stock solution of cefepime and amikacin was prepared by dissolving 100 mg of the drug in 100mL volumetric flask with methanol individually. Aliquots of this solution were suitably diluted with mobile phase to get working standard solutions of cefepime and amikacin in the concentration range of 2.5-25 μg/mL for amikacin and 10-100 μg/mL for cefepime. The purity of the drug peak obtained from the stressed sample was measured by UV detector and compares the chromatogram of untreated drugs in tablet solution
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