Carry out the method for liquid
chromatography, using the following solutions.
Test Solution: (1) Add a quantity of
the powdered tablets containing the equivalent of 2 g of ciprofloxacin to 750
mL of the mobile phase, mix with the aid of ultrasound for 20 minutes, add
sufficient mobile phase to produce 1000 mL and mix. Filter a portion of the
resulting suspension (Whatman GF/C filter paper is suitable) and Further dilute
25 ml of the filtrate to 100 ml with mobile phase to produce a
solution containing the equivalent of 0.05% w/v of ciprofloxacin.
Standard Solution :(2) 0.058% w/v of ciprofloxacin
hydrochloride ws in the mobile phase.
( Weigh accurately about 58 mg of
Ciprofloxacin Hydrochloride (equivalent to 50 mg of Ciprofloxacin ) in a 100 ml
volumetric flask, dissolve in about 70 ml of mobile phase and dilute to 100 ml
with mobile phase )
CHROMATOGRAPHIC
CONDITIONS
(a) Use a stainless steel
column (25 cm × 4.6 mm) packed with base-deactivated octadecylsilyl silica gel
for Chromatography (5 µm) (Nucleosil 120-C18 and LiChrospher 100 RP 18 are
suitable).
(b) Use isocratic elution and the
mobile phase described below.
(c) Use a flow rate of 1.5 mL per
minute.
(d) Use a column temperature of 40°.
(e) Use a detection wavelength of 278
nm.
(f) Inject 5 µL of each solution.
MOBILE PHASE
13 volumes of acetonitrile and 87
volumes of a 0.245% w/v solution of orthophosphoric acid the pH of
which has been adjusted to 3.0 with triethylamine.
DETERMINATION OF
CONTENT
Calculate the
content of C17H18FN3O3 in the
tablets using the declared content of C17H18FN3O3,
HCl in ciprofloxacin hydrochloride ws. Each mg of C17H18FN3O3,
HCl is equivalent to 0.9010 mg of C17H18FN3O3.
Mg/tablet =
Area of Spl. x std wt. x 1000___ x
100 Average weight x Std Potency x 0.9010
Area of Std. 100
Spl. Wt. 25
(mg)
100
(mg)
Mg/tablet x100
% =--------------------
Labeled Claim
