Monday 9 October 2017

Dexamethasone Tablets (Assay) (By HPLC) | Finished Product | Test Procedure | Method of analysis (MOA) |














Weigh and powder 20 tablets. Carry out the method for liquid chromatography, using the following solutions.  

Test solution : Test (1) To a quantity of the powdered tablets containing 2.5 mg of Dexamethasone add 20 mL of methanol  (50%), shake & Sonicate  for 20 minutes and filter through glass-fibre filter (Whatman GF/C is suitable). 

Standard solution : (2) 0.0125% w/v of dexamethasone ws in methanol (50%). Weigh accurately about 50 mg of Dexamethasone in 100 ml volumetric flask add 50 ml of methanol  (50%) shake & Sonicate for atleast 20 minutes & dilute to 100 ml with methanol . Further dilute 5 ml to 20 ml with methanol (50 %)
  
 CHROMATOGRAPHIC CONDITIONS:

Use a stainless (a) steel column (20 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS 1 is suitable).
  
 (b) Use  phase described below. isocratic elution and the mobile
  
 (c) Use a flow rate of 1.4 mL per minute.
  
 (d) Use an  ambient column temperature.
  
 (e) Use a detection wavelength of 238 nm.
  
 (f) Inject 20 µL of each solution.


 DETERMINATION OF CONTENT
  
Calculate the content of C22H29FO5 in the tablets using the declared content of C22H29FO5 in dexamethasone ws.