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.