Dissolution
:
Medium: pH 6.0 phosphate
buffer; 900 mL
Apparatus 2: 75 rpm
Time: 30 min
Solution A and Mobile phase:
Prepare as directed for the Assay.
Solution B: 17.5 mg/mL of
dibasic potassium phosphate, adjusted with phosphoric acid to a pH of 8.00 ±
0.05
Diluent: Acetonitrile and
Solution B (1:4)
Standard stock solution: Dissolve Azithromycin RS in Medium to obtain a
solution having a known concentration of about L/1000 mg/mL, where L is the
tablet label claim, in mg.
Standard solution: Dilute Standard stock solution with Diluent to obtain a
solution having a known concentration of about L/2000 mg/mL, where L is the
tablet label claim, in mg.
Sample solution: Pass a portion of the solution under test through a
suitable 0.45-µm filter. Dilute a portion of the filtrate with Diluent to
obtain a solution having a nominal concentration of about L/2000 mg/mL, where L
is the tablet label claim, in mg, assuming complete dissolution.
Chromatographic system
Mode: LC
Detector: UV 210 nm
Column: 4.6-mm × 15-cm
column; 5-µm packing L1
Temperature: 50°C
Flow rate: 1.5 mL/min
Injection size: 50 µL
System suitability
Sample: Standard solution
Suitability requirements:
Column efficiency: NLT
1000 theoretical plates
Tailing factor: NMT
2.0
Relative standard deviation:
NMT 2.0%
Analysis
Samples: Standard solution and
Sample solution
Determine the amount of C38H72N2O12
dissolved:
Samples: Standard solution and
Sample solution
Determine the amount of C38H72N2O12
dissolved:
Result = (rU/rS) × (CS/L) × V
× 100
|
rU
|
=
|
peak response of azithromycin from the Sample solution
|
|
rS
|
=
|
peak response of azithromycin from the Standard solution
|
|
CS
|
=
|
concentration of USP Azithromycin RS in the Standard solution
(mg/mL)
|
|
L
|
=
|
label claim (mg/Tablet)
|
|
V
|
=
|
volume of Medium, 900 mL
|
Tolerances:
NLT 80% (Q) of the labeled amount of C38H72N2O12 is dissolved.
