1.0) Description: Visual
2.0) Average Weight: Check weight of 20 tablets at random 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 (%) = Weight of each tablet – Average weight x 100
Average weight
| Average weight of tablets | Percentage deviation |
| 250 mg or More | ±5% |
4.0) Identification Test:
- For Rutoside Trihydrate and Diclofenac Sodium: In the assay the principal peaks in the chromatogram obtained with the test solution corresponds to the principal peaks in the chromatogram obtained with the reference solution.
- Bromelain and Trypsin: As per assay from outside lab.
5.0) 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.
6.0) Disintegration Time:
Unless otherwise stated in the individual monograph, introduce one tablet in each of the basket and if the tablet has a soluble external coating, immerse the basket in water at room temperature for 5 minutes. Then operate the apparatus using simulated gastric fluid temperature maintained at 37±2° as the immersion fluid. After 2 hour of operation in simulated gastric fluid, lift the basket from the fluid, and observe the tablets. The tablets show no evidence of disintegration, cracking, or softening. Operate the apparatus, using simulated intestinal fluid temperature maintained at 37±2° as the immersion fluid, for the time specified in the monograph. Lift the basket from the fluid and observe the tablets. All of the tablets disintegrate 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.
7.0) Dimension of Tablet:
Diameter 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 upto 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.
NOTE: Prepare the solutions immediately before use. Protect the solutions from light.
Test solution: Weigh and powder 20 tablets. Weigh a quantity of powder containing about 25 mg of Diclofenac Sodium in 100 ml of methanol and sonicate to dissolve. Filter and dilute 2ml to 25 ml in mobile phase.
Reference solution: Weigh 25 mg of Diclofenac Sodium and 50 mg of Rutoside Trihydrate in 100 ml of methanol dissolve. Dilute 2 ml to 25 ml with mobile phase.
Chromatographic system:
- A stainless steel column 25 cm X 4.6 mm, packed with octadecylsilane bonded to porous silica (5µm)
- Mobile phase-800 ml Methanol+200 ml water+ 1ml Glacial acetic acid
- Flow rate: 1 ml per minute,
- Spectrophotometer set at 280 nm,
- Injection volume: 20 µl
Inject the sample and standard solution.
Calculate the content of Diclofenac sodium and Rutoside Trihydrate in the tablets.
Abs. of Test STD Wt.(mg) 2 100 25 Potency
—————–X—————-X——-X——————-X——X—————X Average wt.
Abs. of STD 100 25 Test Wt.(mg) 2 100
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
inHg: Inch of Mercury
mg: Milligram
ml: Milliliter
