Estimation of loratadine tablets (10mg) formulation

1.0 OBJECTIVE                    

To provide the procedure for Estimation of loratadine tablets (10mg) formulation.

2.0 SCOPE

This procedure is Applicable to the Estimation of loratadine tablets (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:

Loratadine  IP 10mg

5.2 Assay Method: 

5.2.1 Standard solution:  

Accurately weigh about 10mg of loratadine working standard and transfer it into 50ml of volumetric flask, add 50 ml of 0.1M methanolic Hcl, 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 0.1M methanolic Hcl.  

5.2.2 Sample solution:

Weigh and powder 20 tablets. Weigh accurately the tablets powder  equivalent to about 10mg of loratadine into 50ml of volumetric flask, add 10ml of 0.1M methanolic Hcl, shake well until dissolve the substance or Sonicate for 3 minutes, make up to volume with 0.1M methanolic Hcl.

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 0.1M methanolic Hcl.  

Measure the absorbance at about 275nm using 0.1M methanolic Hcl 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