Labeling—
It meets the requirement for
Labeling under
Injections 
1
. Where it is maintained in the frozen state, the label states that it is to be thawed just prior to use, describes the conditions for proper storage of the resultant solution, and directs that the solution is not to be refrozen.
Assay—
Mobile phase—
Dissolve 10.54 g of monobasic potassium phosphate in 775 mL of water, and adjust with phosphoric acid to a pH of 2.5. Add 225 mL of acetonitrile, mix, and filter. Make adjustments if necessary (see
System Suitability under
Chromatography 621).
[NOTE—Ensure that the concentration of acetonitrile in the
Mobile phase is not less than 22% and not more than 25% in order to retain the correct elution order.
]
Standard preparation—
Dissolve an accurately weighed quantity of
USP Clindamycin Phosphate RS in
Mobile phase to obtain a solution having a known concentration of about 0.24 mg per mL.
Assay preparation—
Transfer an accurately measured volume of Injection, equivalent to about 300 mg of clindamycin, to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix. Transfer 7.0 mL of the resulting solution to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Resolution solution—
Prepare a solution of
USP Benzyl Alcohol RS in
Mobile phase to obtain a solution having a concentration of about 0.1 mg per mL. Add about 25 mL of this solution to a 100-mL volumetric flask containing about 25 mg of
USP Clindamycin Phosphate RS, dilute with
Mobile phase to volume, and mix.
Chromatographic system (see Chromatography 621)—
The liquid chromatograph is equipped with a 210-nm detector and a 4.6-mm × 25-cm column that contains packing L7. The flow rate is about 1 mL per minute. Chromatograph the
Resolution solution, and record the peak responses as directed for
Procedure: the relative retention times are 1.0 for clindamycin phosphate and about 1.2 for benzyl alcohol; and the resolution,
R, between clindamycin phosphate and benzyl alcohol is not less than 2.0. Chromatograph the
Standard preparation, and record the peak responses as directed for
Procedure: the relative standard deviation for replicate injections is not more than 2.5%.
Procedure—
Separately inject equal volumes (about 20 µL) of the
Standard preparation and the
Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of clindamycin (C
18H
33ClN
2O
5S) in each mL of the Injection taken by the formula:
(10/7)(CP/V)(rU / rS),
in which
C is the concentration, in mg per mL, of
USP Clindamycin Phosphate RS in the
Standard preparation; P is the potency, in µg of C
18H
33ClN
2O
5S per mg, of
USP Clindamycin Phosphate RS;
V is the volume, in mL, of Injection taken; and
rU and
rS are the clindamycin phosphate peak responses obtained from the
Assay preparation and the
Standard preparation, respectively.
