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

1.0 OBJECTIVE                    

To provide the procedure for the determination of Diltiazem hydrochloride tablets (30/90/60/120mg)

2.0 SCOPE

This procedure is Applicable to the determination of Diltiazem hydrochloride tablets (30/90/60/120mg)

3.0 RESPONSIBILITY 

3.1 QC-Chemist 

4.0 ACCOUNTABILITY         

4.1 Executive – Quality control

4.2 Head – Quality control

5.0 PROCEDURE      

    

 5.1 Label Claim: 

Each uncoated tablet Contains:

Diltiazem hydrochloride IP ……………….30/90/60/120mg

5.2 Assay Method: 

5.2.1 Preparation of standard solution:

Dissolve 100mg of the Diltiazem hydrochloride in 50ml of chloroform and further diluted to 100ml with chloroform. Further dilute 10ml of the above solution into 100ml with chloroform.

5.2.2 Preparation of Sample solution:

Weight powder twenty tablets and take the powder equivalent to100mg Diltiazem hydrochloride was accurately weighed, dissolved in 100 ml of chloroform, filtered through Whatmann filter paper No: 41.

Further dilute 10ml of the above solution into 100ml with chloroform.

5.2.3 Measure the absorbance at about 249.8 nm

5.2.4 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