Abstract
A Validated Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Cefixime Trihydrate and Levofloxacin Hemihydrate in Pharmaceutical Dosage Form
Highlights
Cefixime trihydrate (CEF) is an oral third generation cephalosporin class of antibiotic. It is (6R, 7R)-7{[2-(2-amino-1,3- thiazol-4-yl)-2(carboxymethoxyimino)acetyl] amino}-3-ethenyl-8-oxo-5-thia-1 azabicyclo-[4.2.0]oct-2-ene-2 carboxylic acid, clinically used in the treatment of susceptible infections including gonorrhea, otitis media, pharyngitis, lower respiratory-tract infections such as bronchitis, and urinary-tract infections [1,2](Figure 1). It is official in Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopoeia (USP), European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP) [3-7]
This paper reports validated stability-indicating HPLC method for simultaneous determination of CEF and Levofloxacin hemihydrates (LEVO) in presence of their degradation products
A series of trials was conducted with different columns like Phenomanax Luna C18 and and C-8 columns with different mobile phases to develop a suitable RP-HPLC method for estimation of CEF and LEVO in tablet dosage form, and a typical chromatogram was obtained with isocratic elution of mobile phase consisting of 0.5% Glacial acetic acid in Water pH adjusted to 4.5 with ammonia solution : Methanol (45:55 % v/v), and at flow rate of 1.0 mL/min The chromatographic separation was performed on Phenomanax Luna C18 (150X4.6) mm, 5μ by injecting 20 μL and analytes were detected with photodiode array (PDA) detector at 290 nm
Summary
Cefixime trihydrate (CEF) is an oral third generation cephalosporin class of antibiotic. It is (6R, 7R)-7{[2-(2-amino-1,3- thiazol-4-yl)-2(carboxymethoxyimino)acetyl] amino}-3-ethenyl-8-oxo-5-thia-1 azabicyclo-[4.2.0]oct-2-ene-2 carboxylic acid, clinically used in the treatment of susceptible infections including gonorrhea, otitis media, pharyngitis, lower respiratory-tract infections such as bronchitis, and urinary-tract infections [1,2](Figure 1). It is official in Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopoeia (USP), European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP) [3-7]. S-isomer isolated from the racemic ofloxacin [23] (Figure 2) It possesses wide spectrum of antibacterial activity against both
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