Analytical Method Development, Validation studies of a Fluoroquinolone chemotherapeutic antibiotic and its Characterization studies

Ciprofloxacin hydrochloride (CFH) is a broad-spectrum antibiotic that is active against both Gram-positive and Gramnegative bacteria used in ulcerative colitis and irritable bowel syndrome. A sensitive analytical UV spectrophotometric method was developed showed its absorption maxima at 271 nm in distilled water between 200 nm and 400 nm. Linearity studies indicated that estimation of CFH between 2.00 μg/ml to 10.00 μg/ml was found to be linear and obeyed beers law with regression equation of y = 0.0985*X 0.0004; (r² = 0.9997). The low SD values of Inter day and Intra day variation studies indicated that the variation is minimum. The accuracy, precision studies showed that the recovery of drug from bulk fluids and dosage form are highly accurate and precise with minimum error. The above analytical parameters indicated that the developed UV Spectrophotometric method for CFH was simple, accurate, precise and reproducible for analysis of drug in different pharmaceutical dosage forms. Characterization studies showed that CFH melting point was 324°C; the solubility studies indicated that, the drug is more soluble in water than in acidic or alkaline media. Further the log p value was observed as -0.538. The results showed that the methods used for drug characterization were simple with repeatable sensitivity.