Estimation of for Metformin Hydrochloride tablets (500mg) formulation.

1.0 OBJECTIVE                    

To provide the procedure for Metformin Hydrochloride  tablets (500mg) formulation.

2.0 SCOPE

This procedure is Applicable to the Metformin Hydrochloride  tablets (500mg) formulation.

3.0 RESPONSIBILITY 

3.1 QC-Chemist 

4.0 ACCOUNTABILITY         

4.1 Executive – Quality control

4.2 Head – Quality control

5.0 PROCEDURE     

     

 5.1 Label Claim: 

Each uncoated tablet contains:

Metformin Hydrochloride  IP    500 mg

5.2 Assay Method: 

5.21 Preparation of standard solution:

Dissolve 100mg of the Metformin hydrochloride in 50ml of double distilled water and further diluted to 100ml with double distilled water. Further dilute 1ml of the above solution into 10ml with double distilled water.

5.2.2 Preparation of Sample solution:

Weight powder twenty tablets and take the powder equivalent to 100mg of Metformin hydrochloride was accurately weighed, dissolved in 50 ml of Double distilled water, filtered through Whatmann filter paper No: 41 and dilute to 100ml with Double distilled water.

Further dilute 1ml of the above solution into 10ml with double distilled water.

5.5.3 In a 25ml of volumetric flaks add 2 ml of the standard solution, 1.5 ml of 5M NaOH,2.2 ml of 1% Ninhydrin solution and 10 ml of water, heat on water bath for 30 minutes, cooled and make up the volume to 25 ml with double distilled water.

5.2.4 Repeat the same procedure with sample Solution.

5.2.5 In a 25ml of volumetric flaks add 2 ml of the standard solution, 1.5 ml of 5M NaOH,2.2 ml of 1% Ninhydrin solution and 10 ml of water, heat on water bath for 30 minutes, cooled and make up the volume to 25 ml with double distilled water.

5.2.6 Measure the absorbance at about 570nm

5.2.7 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

5.2.8 Principle

The primary amino group of Metforomin hydrochloride reacted with ninhydrin in alkaline medium to form a violet colour chromogen, which is determined at 570 nm

6.0 ANNEXURES

Nil