Determination of Gliclazide(80mg) in tablet dosage form

 1.0 OBJECTIVE                    

To provide the procedure for the determination of Gliclazide in tablet dosage form

2.0 SCOPE

This procedure is Applicable to the determination of Gliclazide in tablet dosage form

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: 

Gliclazide IP  80mg

5.2 Assay Method: 

5.21 Preparation of standard solution:

Dissolve 100mg of the Gliclazide in 50ml of methanol and further diluted to 100ml with methanol.

Further dilute 1ml of the above solution into 10ml with methanol.

5.2.2 Preparation of Sample solution:

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

Further dilute 1ml of the above solution into 10ml with methanol.

5.2.3 Measure the absorbance at about 230nm

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