Saturday 21 October 2017

Method of analysis of Tramadol Capsules (Assay) (By HPLC)| Finished Product | Test Procedure | Method of analysis (MOA) |



 













Carry out the method for liquid chromatography, using the following solutions.


Solution preparation:
Mobile phase:  5 ml  of trifluoroacetic acid, 150ml of acetonitrile and 345 volumes of water.

Standard solution: Weigh accurately about 25 mg of Tramadol Hydrochloride working standard in 100 ml volumetric flask, add 70 ml mobile phase, sonicate it 10 minutes , dilute to the volume with mobile phase.

Test solution: Weigh and transfer __ mg of the powder, equivalent to 25 mg of Tramadol Hydrochloride, to a 100-ml volumetric flask. Add 70 ml of mobile phase, sonicate it half an hours, dilute with mobile phase to volume, mix, filter.

CHROMATOGRAPHIC CONDITIONS:

Column           : Use a stainless steel column (25 cm × 4.6 mm) (5 µm) ( C18 ).
Flow rate         : 1.0 ml/min.
Injection volume : 20 µl
Column temperature: Ambient
Wavelength    : 271 nm.
Method           : Isocratic

Procedure: Inject the blank (one time), standard solution (six times) and test solution (two times)

The relative standard deviation of six replicate standards should not be more than 2 %.

Calculation

   
Calculate the content of C16H25NO2, HCl using the declared content of C16H25NO2,HCl in tramadol hydrochloride. 

The content per capsule is calculated by the equation

Calculation :