Estimation of Diltiazem hydrochloride tablets(30/60/90/120mg) formulation

1.0 OBJECTIVE                    

To provide the procedure for Estimation of Diltiazem hydrochloride tablets(30/60/90mg)formulation.

2.0 SCOPE

This procedure is Applicable to the Estimation of Diltiazem hydrochloride  tablets(30/60/90mg) 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 film coated tablet contains:

Diltiazem hydrochloride  IP 30/60/90mg

5.2 Assay Method: 

5.2.1 Standard solution:  

Accurately weigh about 10mg of Diltiazem hydrochloride 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 10mg of Diltiazem hydrochloride 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 No. 41 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 236nm 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