Dissolution:
Note: Do not expose any of the solutions to stainless steel
because of the degradation of amlodipine.
Solution preparation: 0.01M Hydrochloric acid: Dilute 5.1 ml hydrochloric acid in
6.0 litre water.
Standard
solution: Weigh accurately about 27.8 mg of amlodipine
besylate WS transfer it into 100 ml volumetric flask add 60 ml medium to dissolve
and make up volume to 100 ml with medium. Further Dilute 10 ml to 100 ml with
medium.
Test Conditions
Medium : 0.01M Hydrochloric acid; 500
ml
Apparatus
2 : Paddle (Use paddles covered
with Teflon or made of any inert material except stainless steel)
Revolution :
75 rpm
Time : 30 min.
Analysis: After
completion of time interval, withdraw a 20 ml of sample from a zone midway
between the surface of the dissolution medium and the top of the rotating
paddle, not less than 1 cm from the vessel wall and filter.
Measure the absorbance of standard and resulting sample, at
the maximum at 239 nm.
Calculation :
Calculate the percentage
of labelled amount of amlodipine dissolved,
Dissolution (%) =
Test Abs. x Wt.
of Std.(mg) x 10 x 500 x 408.88
x Std. Potency x 100
Standard Abs. 100 100 Label clame 567.06 100
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Acceptance criteria: Not less than 75% (Q)
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