Solution A: 0.01 M phosphoric acid and
0.01 M monobasic sodium phosphate (1:1). If necessary, adjust with additional
portions of the appropriate components to a pH of 2.5 (± 0.2).
Mobile phase : Methanol and Solution A (7:3)
Diluent : Methanol and water (7:3)
Standard solution: Take 50 mg of Diclofenac
Potassium working Standard in 100 ml volumetric flask, add 70ml Diluent
sonicate it half an hours, remaining volume makeup with Diluent.
Sample solution: Weigh and
finely powder NLT 20 Tablets. Transfer a portion of the powder, nominally
equivalent to 50 mg of diclofenac potassium, to a 100-mL volumetric flask.
Add 70 mL of Diluent, stir for 60 min, dilute with Diluent to volume, mix,
and centrifuge.
CHROMATOGRAPHIC CONDITIONS
(a) Column : 4.6-mm × 25-cm; 5-µm packing L7
(b) Use isocratic elution and the mobile phase described as
above
(c) Use a flow rate of 1.0 mL per minute.
(d) Use an ambient column temperature.
(e) Use a detection wavelength of 254 nm.
(f) Inject 20 µL of each solution. Calculation: |
Sunday, 8 October 2017
Diclofenac potassium Tablets (Assay) (By HPLC) | Finished Product | Test Procedure | Method of analysis (MOA) |
Posted by mypharmasolution.blogspot.com on October 08, 2017