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Cefoperazone Sodium and Sulbactam Sodium for Injection / Official Monographs iP XVII
with 25 .uL of the standard solution under the above operat-
ing conditions, the relative standard deviation of the peak Cefoperazone Sodium and Sulbac-
areas of cefoperazone is not more than 2.0%.
tam Sodium for Injection
Water <2.48) Not more than 1.0% (3 g, volumetric titra-
tion, direct titration). ;iMIfl1z7;;t -e '7 '/::...-7- ~ I) '7L... :A)[...ri? -$' L..7- ~ I) '7
L..
Assay Weigh accurately an amount of Cefoperazone So-

Cefoperazone Sodium and Sulbactam Sodium for

dium equivalent to about 0.1 g (potency), and dissolve in
water to make exactly 100 mL. Pipet 5 mL of this solution,
add exactly 5 mL of the internal standard solution, and use Injection is a preparation for injection which is dis-
this solution as the sample solution. Separately, weigh accu- solved before use.
rately an amount of Cefoperazone RS equivalent to about It contains not less than 90.0% and not more
20 mg (potency), dissolve in I mL of 0.1 mollL phosphate than 110.0% of the labeled potency of cefoperazone
buffer solution (pH 7.0) and add water to make exactly 20 (C2sH27N90SS2: 645.67), and not less than 95.0% and
mL. Pipet 5 mL of this solution, add exactly 5 mL of the in- not more than 110.0% of the labeled potency of sul-
ternal standard solution, and use this solution as the stand- bactam (CsHIiNOsS: 233.24).
ard solution. Perform the test with 10.uL each of the sample Method of Preparation Prepare as directed under Injec-
solution and standard solution as directed under Liquid tions, with Cefoperazone Sodium and Sulbactam Sodium.
Chromatography <2.01) according to the following condi-
tions, and calculate the ratios, QT and Qs, of the peak area Description Cefoperazone Sodium and Sulbactam Sodium
of cefoperazone to that of the internal standard. for Injection occurs as white to pale yellowish white, masses
or powder.
Amount Lug (potencyj] of cefoperazone (C25H27N90sS2)
= Ms x QTIQs x 5000 Identification (1) The retention times of cefoperazone in
the chromatogram obtained from the sample solution and
Ms: Amount [mg (potency)] of Cefoperazone RS taken the standard solution in the Assay are the same, and the
Internal standard solution-A solution of acetanilide in a peak area of cefoperazone obtained from the sample solu-
mixture of water and acetonitrile (43:7) (3 in 8000). tion in the Assay is 0.8 to 1.1 times the peak area of cefoper-
Operating conditions- azone obtained by the test performed with 10.uL of the sam-
ple solution obtained in the Assay as directed under Liquid
Detector: An ultraviolet absorption photometer (wave-
Chromatography <2.01) according to the following condi-
length: 254 nrn).
tions.
Column: A stainless steel column 4.6 mm in inside diame-
Operating conditions-
ter and 15 ern in length, packed with octadecylsilanized silica
Column, column temperature, mobile phase, and flow
gel for liquid chromatography (5.um in particle diameter).
rate: Proceed as directed in the operating conditions in the
Column temperature: A constant temperature of about Assay.
35°C. Detector: An ultraviolet absorption photometer (wave-
Mobile phase: To 57 mL of acetic acid (100) add 139 mL
length: 230 nm).
of triethylamine and water to make 1000 mL. To 20 mL of
System suitability-
this solution add 835 mL of water, 140 mL of acetonitrile
System performance: Proceed as directed in the system
and 5 mL of dilute acetic acid.
suitability in the Assay.
Flow rate: Adjust so that the retention time of cefopera-
(2) The retention times of sulbactam in the chromato-
zone is about 10 minutes.
gram obtained from the sample solution and the standard
System suitability-
solution in the Assay are the same, and the peak area of sul-
System performance: When the procedure is run with 10
bactam obtained from the sample solution in the Assay is 1.4
.uL of the standard solution under the above operating con-
to 1.9 times the peak area of sulbactam obtained by the test
ditions, the internal standard and cefoperazone are eluted in
performed with 10.uL of the sample solution obtained in the
this order with the resolution between these peaks being not
Assay as directed under Liquid Chromatography <2.01) ac-
less than 5.
cording to the following conditions.
System repeatability: When the test is repeated 6 times
Operating conditions-
with 10.uL of the standard solution under the above operat-
Column, column temperature, mobile phase, and flow
ing conditions, the relative standard deviation of the ratios
rate: Proceed as directed in the operating conditions in the
of the peak area of cefoperazone to that of the internal
Assay.
standard is not more than 1.0%.
Detector: An ultraviolet absorption photometer (wave-
Containers and storage Containers-Hermetic containers. length: 230 nm),
Storage-In a cold place. System suitability-
System performance: Proceed as directed in the system
suitability in the Assay.

pH <2.54) The pH of a solution prepared by dissolving an

amount of Cefoperazone Sodium and Sulbactam Sodium for
Injection, equivalent to 1.0 g (potency) of Cefoperazone So-
dium, in 20 mL of water is 4.5 to 6.5.

Purity (1) Clarity and color of solution-A solution of an

amount of Cefoperazone Sodium and Sulbactam Sodium for
Injection, equivalent to 0.5 g (potency) of Cefoperazone So-
dium, in 10 mL of water is clear. Perform the test with this

The JP Drugs are 10 be tested according 10 the provisions given in the pertinent monographs, General Notices, General Rules jar Crude Drugs,
General Rilles for Preparations, and General Tests for their conformity 10 the Japanese Pharmacopoeia. (See the General Nolices 5.)