Estimation of Amlodipine tablets(2.5/5/10mg) formulation

1.0 OBJECTIVE                    

To provide the procedure for Estimation of Amlodipine besylate tablets(2.5/5/10mg) formulation.

2.0 SCOPE

This procedure is Applicable to the Estimation of Amlodipine besylate tablets(2.5/5/10mg) formulation.

3.0 RESPONSIBILITY

3.1 QC-Chemist 

4.0 ACCOUNTABILITY

4.1 Executive – Quality control

4.2 Head – Quality control

5.0 PROCEDURE  

 5.1Label Claim: 

Each Uncoated tablet contains:

Amlodipine besylate  IP/BP/USP  

equivalent to Amlodipine  2.5/5/10mg

5.2 Assay Method: 

5.2.1 Standard solution:  

Accurately weigh about 50mg of Amlodipine besylate working standard and transfer it into 50ml of volumetric flask, add 50 ml of Double distilled water, shake well until the material gets dissolved and make up to 100ml with above solution.  

Transfer 1ml of the above solution into 10 ml with Double distilled water.  

5.2.2 Sample solution:

Weigh and powder 20 tablets. Weigh accurately the tablets powder  equivalent to about 50mg of Amlodipine besylate into 50ml of volumetric flask, add 10ml of Double distilled water, shake well until dissolve the substance or Sonicate for 3 minutes, make up to volume with Double distilled water.

Filter the sample Solution with whatman filter paper and  reject first few ml of the filtrate. 

Transfer 1ml of the above solution into 10 ml with Double distilled water.  

Measure the absorbance at about 238nm using double distilled water as blank

5.2.3 Calculate the content by comparison.

Sample absorbance    x  Standard weight  x Assay x Average weight of the tablet = 

Standard absorbance  x  Sample Weight   x   100     

= ____________x100

         LC 

LC: Label Claim

6.0 ANNEXURES

Nil