standard test procedure aceclofenac and paracetamol tablets

Description : By visually inspection

Identification: The retention time of the major peaks for Aceclofenac & paracetamol obtained from assay

preparation should correspond to that of standard preparation as described under the assay .

Average Weight & Uniformity of Weight :

Equipment : A suitable analytical balance.

Procedure : Select 20 tablets from composite sample & weigh accurately on balance. Divide the total weight

by 20 and calculate the average weight . Now weigh each tablet individually , select minimum and

maximum weight and calculate variation by formula given as under ( in percentage)

———————————- Minimum Weight – Average Weight

For (- ) variation = ————————————————— x 100

– ———————————– Average Weight

– ————Maximum Weight – Average Weight

For ( + ) variation = ————————————————— x 100

– —————Average Weight

Length :

Equipment: Vernier Calliper.

Procedure: Hold the tablet vertically between the jaw of the calliper and slide the adjustable

jaw towards the tablet till it is hold firmly between the jaws. Record the

reading of Length of the tablet in mm. Take the reading of at least 5 tablets and

calculate the average value.

Thickness :

Equipment: Vernier Calliper.

Procedure : Hold the tablet vertically between the jaws of the calliper and slide the adjustable

jaw towards the tablet till it is hold firmly between the jaws. Record the reading

of thickness of the tablet in mm. Take the reading of at least 5 tablets and

calculate the average value.

Width :

Equipment: Vernier Calliper

Procedure : Hold the tablet vertically between the jaws of the calliper and slide

the adjustable jaw towards the tablet till it is hold firmly between the jaws.

Record the reading of width of the tablet in mm. Take the reading of at

least 5 tablets and calculate the average value.

Disintegration Time:

Equipment: Disintegration test apparatus.

Procedure: Place 1 tablet in each of the six tubes of the basket, using water maintained at 37±2° as

the immersion fluid and operate the apparatus. Observe the tablets and note the time which all of the

tablets have disintegrated completely not more than 30 minutes . If 1 or 2 tablets fail to disintegrate completely

repeat the test on 12 additional tablets: not less than 16 of the total of 18 tablets tested disintegrate completely.

ASSAY (BY HPLC):
ESTIMATION OF ACECLOFENAC& PARACETAMOL: (BY HPLC)

Instrumental Conditions:
Column : Symmetry C8, 250 x 4.6 mm, 5µ
Flow rate : 1.0 ml/min
Wave length : 275 nm
Injection Volume : 20µl
Column temperature : Ambient
Run time : 15 minutes
Buffer Potassium Phosphate Buffer pH 5.5 Preparation: Dissolve 6.8 gm of potassium
dihydrogen phosphate in 1000 ml water, adjust pH 5.5 + 0.05 with dilute
Potassium hydroxide solution and mix.
Mobile phase preparation: Prepare a mixture Buffer, and Acetonitrile in the ratio (55:45). Filter through
0.45µ filter and degas.

Standard Preparation: Weight accurately 40 mg Aceclofenac and 200mg paracetamol WS into a 100 ml volumetric flask.

Dissolve in50 ml of mobile phase sonicate for 5 minutes and dilute up to mark with mobile phase and mix.

Further dilute5ml of this solution to 50ml with mobile phase. Filter through 0.45 micron

Test preparation: Weight and powder of 20 tablets. Weigh accurately equivalent to 40 mg of Aceclofenac and

200mg paracetamol into100 ml volumetric flask. Dissolve in50 ml of mobile phase sonicate for 5 minutes and

dilute up to mark with mobile phase and mix. Further dilute5ml of this solution to 50ml with mobile phase.

Filter through 0.45 micron.

System Suitability: Separately inject 20 µl of the standard preparation in six replicate
Injections into the liquid chromatograph and record the chromatograms. Check the theoretical plates, tailing factors.

The theoretical plates should not less than 1000 and tailing factor should not more than 2.

The relative standard deviation for six replicate injection
should not more than 2%.

Procedure : Separately inject 20 µl of standard preparation and test preparation into liquid chromatograph

and record the chromatograms. Measure the responses for major peak areas of standard and

test preparation from percent potency of working standard used.

Calculation of Aceclofenac: