STABILITY STUDY ON CIPROFLOXACIN

Abstract

In this work, the stability of ciprofloxacin hydrochloride in solid form was compared with that of ciprofloxacin free base under the different Sudanese environment conditions such as high temperature, sun light and ultraviolet rays. The results of this study showed that, this drug is not affected by high temperature up to 110 o C but affected by sun light. Ciprofloxacin free base was found to be more degraded than ciprofloxacin hydrochloride. In aqueous media ciprofloxacin hydrochloride and ciprofloxacin free base were affected by sun light, but not affected by temperature up to 70 oC. Thin layer chromatography (TLC) studies showed that the sun- decomposition of ciprofloxacin hydrochloride and ciprofloxacin free base increased gradually with increasing time leading to the formation of three decomposition products. The hydrolysis of Cipro-HCl with sodium hydroxide solution increased by increasing the concentration of sodium hydroxide and temperature. In acidic media (hydrochloric acid solution) the drug is not affected up to 70 oC .The increase of Cipro- HCl and Cipro-free base concentration in solutions has decreased the photo thermal decomposition rate. The results obtained revealed that, with the high pH - value there was an increase in the photo thermal decomposition rate. The study proved that the use of some chemical compounds as excipients for drug preparation lead to the stabilization of the drug against photo ii thermal decomposition. Examples of these excipients include microcrystalline cellulose, methyl paraben, propyl paraben, talcum, starch and stearic acid . Other excipients lead to the increasing the rate of photo thermal decomposition as methyl paraben sodium, propyl paraben sodium, sodium benzoate and magnesium stearate. All the photo thermal reactions of ciprofloxacin hydrochloride and ciprofloxacin free base in aqueous media were found to follow first order reaction kinetics. In this work, it was proved that high performance liquid chromatography (HPLC) was the most suitable stability indicating method for the decomposition of both Cipro-HCl and Cipro-free base.