Estimation of Enalapril maleate tablets (2.5/5/10/20 mg) formulation

1.0 OBJECTIVE                    

To provide the procedure for Estimation of Enalapril maleate tablets (5mg) formulation.

2.0 SCOPE

This procedure is Applicable to the Estimation of Enalapril maleate tablets (5mg) 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:

Enalapril maleate  IP                    2.5/5/10/20 mg

5.2 Assay Method: 

5.2.1 Preparation of Phosphate Buffer Solution 4.0

Dissolve 3.58 g of disodium hydrogen phosphate dodecahydrate in water and diluted to 500 mL with the same solvent. The pH value was adjusted with phosphoric acid.

5.2.1 Standard solution:  

Dissolve 10 mg Enalapril maleate was transferred into 100 mL volumetric flask, dissolved in phosphate buffer at pH 4 and filled up to 100 mL with the same solvent.

From the above solution transfer 10 ml into 200ml volumetric flaks and dilute upto the mark with same solvent.

5.2.2 Sample solution:

Weigh and powder 20 tablets. Weigh accurately the tablets powder  equivalent to about 10mg of Enalapril maleate into 50ml of volumetric flask, add 20ml of  phosphate buffer at pH 4 shake well until dissolve the substance or Sonicate for 3 minutes, make up to volume with  phosphate buffer at pH 4.0.

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

From the above solution transfer 10 ml into 200ml volumetric flaks and dilute upto the mark with same solvent.

Measure the absorbance at about 208nm using phosphate buffer at pH 4.0 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