1.0) Description: Visual
2.0) Average Weight: Check weight of 20 tablets at randomly and calculate the average weight by formula.
Average weight (mg) = wt of 20 tablets (gm) x 1000
20
3.0) Uniformity of weight:
Weigh 20 tablets selected at random and calculate the average weight. Not more than two of the individual weights deviate from the average weight by more than the percentage shown in table.
Weigh the tablets individually and calculate the percentage of deviation for each tablet by using formula.
Deviation (%) = (experimental weight – theoretical weight) x 100
Theoretical weight
| Average weight of tablets | Percentage deviation |
| 250mg or More | 5% |
4.0) Identification Test:
In the assay, the retention time of the principal peaks in the chromatogram obtained with the test solution corresponds to the peak in the chromatogram obtained with the reference solution.
5.0) Disintegration Test:
Unless otherwise stated in the individual monograph, introduce one tablet into each tube and add a disc to each tube. The assembly is suspended in the liquid medium in a suitable vessel, preferably a 1-litre beaker. The volume of liquid is such that the wire mesh at its highest point is at least 15mm below the surface of the liquid, and at its lower point is at least 25mm above the bottom of the beaker. At no time should the top of the basket-rack assembly become submerged. There is a thermostatic arrangement for heating the liquid and maintaining the temperature at 37±2°.
If 1 or 2 tablets fail to disintegrate, repeat the test on 12 additional tablets; not less than 16 of the total of 18 tablets tested disintegrate.
If the tablets adhere to the disc and the preparation under examination fails to comply, repeat the test omitting the disc. The preparation complies with the test if all the tablets in the repeat test disintegrate.
6.0) Hardness:
The standard method used for tablet hardness testing is compression testing. The tablet is placed between two jaws that crush the tablet. The machine measures the force applied to the tablet and detects when it fractures. Although compressive force is applied to the tablet, along the diameter of the tablet at right angles to the applied force.
7.0) Dimension of Tablet:
Length, breadth and thickness are determined by vernier calliper in mm.
8.0) Leak test:
The apparatus is used to test for the integrity of packed strips, blisters and Alu-Alu Blister pack containing tablets. Ensure apparatus bath is filled with purified water up to mark indicated and add 0.5% crystal violet solution in water. Samples are placed into the desiccators and the lid is placed in position. The pump starts to produce a vacuum 15inHg inside the desiccators and the vacuum is held for 1 minute. The sample remains at the required vacuum level for given time interval buzzer will sound after time is over and will cut off the vacuum pump. As the package is immersed in a colored dye solution the venting of the desiccators will allow any holes to be penetrated by the dye and the contents of the flexible packaging will also be stained with the same coloring material.
Examine all the strips for any leakage by opening the pockets manually. If anyone pocket shows evidence of leakage, reject the sample, stop the Blister / Strip machine and immediately take corrective action.
9.0) Assay:
Determined by liquid chromatography:
Standard solution: Weigh accurately about 162.5 mg of Paracetamol reference standard, and 50 mg of Aceclofenac reference standard in 100ml volumetric flask, dissolve in and dilute to the mark with mobile phase. Shake well and further dilute 2 ml to 25 ml with mobile phase. Shake well and filter through 0.45µm nylon filter.
Test Solution: Weigh accurately about equivalent to 162.5 mg of Paracetamol from crushed powder of 20 tablets in 100 ml volumetric flask, add 50 ml of mobile phase, sonicate for 5 minutes, cool to room temperature and dilute to the mark with mobile phase, filter. Shake well and further dilute 2 ml to 25 ml with mobile phase, shake well and filter through 0.45µm nylon filter.
Procedure: Inject separately standard and test preparation. Inject five replicate injection of working standard and two replicate injection of test preparation.RSD of replicate injection should not more than 2%. Calculate the assay of Paracetamol and Aceclofenac by comparison to peak area of standard preparation.
Chromatographic system:
- A stainless steel column (25cm X4.6mm,) C18
- Mobile phase: Methanol :Water and G.A.A. (80: 20) and (0.01ml); degas
- Flow rate: 1.2ml per minute,
- Spectrophotometer set at 280nm,
- Injection volume: 20µl
Inject the reference solution and test solution.
Calculate the content of Aceclofenac and Paracetamol in tablets.
Formula:
Area of Test STD Wt.(mg) 2 100 25 Potency
—————–X————–X———-X—————–X——X———–X Average weight
Area of STD 100 25 Test Wt. (mg) 2 100
Acceptance criteria: 90.0%-110.0%
10.0) MICROBIOLOGICAL PURITY
Perform the test according to requirements of IP,
Total aerobic Microbial count (TAMC): NMT 103 CFU/g
Total combined yeasts/Moulds count (TYMC): NMT 102 CFU/g
Pathogens: in 1gm drug.
Escherichia Coli – Should be absent
Pseudomonas aeroginosa – Should be absent
Salmonella – Should be absent
Staphylococcus aureus– Should be absent
Abbreviations:
Wt.: Weight
mg: MilLigram
ml: Millileter
G.A.A: Glacial acetic acid
inHg: Inch of Mercury
CFU: Colony forming unit
Std: Standard
RSD: relative standard deviation
