Estimation of Montelukast sodium from Tablet Formulations

1.0 OBJECTIVE                    

To provide the procedure for Estimation of Montelukast sodium from Tablet Formulations.

2.0 SCOPE

This procedure is Applicable Estimation of Montelukast sodium from Tablet Formulations

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: 

Montelukast sodium Tablets IP/BP/USP 

Equivalent to Montelukast sodium .................10mg

5.2 Assay Method: 

5.2.1 Standard solution:  

Accurately weigh about 50mg of Montelukast sodium  working standard and transfer it into 100ml 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 solution to 50ml of volumetric flask; make up to mark by double distilled water.(10mg/ml)

5.2.2 Sample solution:

Weigh and powder 20 tablets. Weigh accurately the tablets powder  equivalent to about 50mg of Montelukast sodium into 100ml of volumetric flask, add 50ml 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 the 1ml of the filtrate in to 50ml of volumetric flask make up to 50ml with the double distilled water. 

Measure the absorbance at about 283nm using double distilled water as blank

5.2.3 Calculate the content by comparison.

Sample absorbance    x  Standard weight  x Assay x     1        xAverage weight of the tablet = 

Standard absorbance  x  Sample Weight   x   100     x 1.0375

= ____________x100

         LC 

LC: Label Claim

6.0 ANNEXURES

Nil