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ABSTRACT:
A simple, rapid, specific, accurate and precise stability indicating reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Azithromycin and Cefixime in Bulk and Tabletdosage form. An Agilant Zorbax C8, 5 µ column having 150 x 4.6mm id in Isocratic mode with mobile phase containing 0.1M Dipotassium Hydrogen Phosphate Buffer : methanol (60:40 %v/v pH: 8.0 adjusted with Ortho phosphoric acid) was used. The flow rate was 1ml/min and effluents were monitored at 230nm. The retention time of Azithromycin and Cefixime was 2.7min and 4.6min respectively. The concentration curves were linear in the concentration range of 250-750µg/mL and 200-600 µ g/mL. The drug was subjected to acid and alkali hydrolysis, oxidation, photolysis and heat as stress conditions. The developed method was validated for specificity, precision, linearity, accuracy, LOD,LOQ, robustness. Recovery of Azithromycin and Cefixime in formulations was found to be in the range of 98% -102% and 98%-102% respectively confirms the non-interferences of the excipients in the formulation. Due to its simplicity, rapidness and good precision, the proposed HPLC method may be used for the simultaneous determination of these two drugs in pharmaceutical dosage forms.
KEYWORDS: RP-HPLC, Azithromycin, Cefixime, Accuracy, Precision.
1. INTRODUCTION:
AZITHROMYCIN (Zithromax)[1-3] is (2R,3S,4R,5R,8R,10R,11R,12S,13R,14R)-13-[2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribohexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. It is a macrolide antibiotic related to erythromycin.It fights bacteria in the body. Zithromax is used to treat many different types of infections caused by bacteria, such as respiratory infections, skin infections, ear infections, and sexually transmitted diseases. In children, it is used to treat middle ear infection, pneumonia, tonsillitis, and strep throat.
Azithromycin prevents bacteria from growing by interfering with their protein synthesis. Azithromycin binds to the 50S subunit of the 70S bacterial ribosomes, and therefore inhibits RNA-dependent protein synthesis in bacterial cells.
CEFIXIME [4-7] is 5,6,7-[2-(2-Aminothiazol-4-yl)2(carboxymethoxyamino)acetoamido]3vinyl-3cephem-4-Carboxlic acid. It is a third generation cephalosporin anti bacterial drug given by oral route in the treatment of susceptible infections including gonorrhea, otitis media, pharynsitis and urinary tract infection. It works by fighting bacteria in the body. Cefixime is used to treat many different types of infections caused by bacteria. The bactericidal action of cephalosporin due to the inhibition of cell wall synthesis.
Reason for the combination of Cefixime with Azithromycin:
Neisseria Gonnorrhoeahe, one of the main pathogens of sexually transmitted male...