Identification
The chromatogram of the
Assay preparation obtained as directed in the
Assay exhibits a major peak for dicloxacillin, the retention time of which corresponds to that exhibited in the chromatogram of the
Standard preparation obtained as directed in the
Assay.
Dissolution 711
Medium:
water; 900 mL.
Apparatus 1:
100 rpm.
Time:
30 minutes.
Procedure
Determine the amount of dicloxacillin (C
19H
17Cl
2N
3O
5S) by a suitable validated spectrophotometric analysis of a filtered portion of the solution under test, suitably diluted with
Dissolution Medium, if necessary, in comparison with a Standard solution having a known concentration of
USP Dicloxacillin Sodium RS in the same
Medium.
Tolerances
Not less than 75% (Q) of the labeled amount of C19H17Cl2N3O5S is dissolved in 30 minutes.
Assay
Diluent, Mobile phase, Standard preparation, and Chromatographic system
Proceed as directed in the
Assay under
Dicloxacillin Sodium.
Assay preparation
Remove, as completely as possible, the contents of not fewer than 10 Capsules, and weigh. Mix, and transfer an accurately weighed portion of the powder, equivalent to about 200 mg of dicloxacillin (C19H17Cl2N3O5S), to a 200-mL volumetric flask, dilute with Diluent to volume, and mix for 10 minutes with the aid of a magnetic stirrer. Filter about 25 mL of the resulting solution, discarding the first 5 mL of the filtrate. Use the clear filtrate as the Assay preparation. [NOTEUse this Assay preparation promptly, or refrigerate and use on the day prepared.]
Procedure
Proceed as directed for
Procedure in the
Assay under
Dicloxacillin Sodium. Calculate the quantity, in mg, of dicloxacillin (C
19H
17Cl
2N
3O
5S) in the portion of Capsule contents taken by the formula:
0.2CE(rU / rS),
in which the terms are as defined therein.