STP for Ambroxol Hcl and Levocetirizine Dihcl tablets

STP for Ambroxol Hcl and Levocetirizine Dihcl tablets

1.0) Description: Visual

2.0) Average Weight: Check weight of 20 tablets at randomly and calculate the average weight by formula :  wt of 20 tablets (gm) x 1000                                              / 20. found avg. wt in mg

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.

Tablets were weighed individually and the percentage of deviation of its weight from the average weight was determined for each tablet. Formula for calculate the percentage of deviation = (experimental weight – theoretical weight)    x 100%

Theoretical weight


Average weight of tablets Percentage deviation
More than 80mg but Less than 250mg 7.5%
250mg or More 5%

4.0)      Identification Test:

In the Assay, the principal peaks in the chromatogram obtained with the test solution corresponds to the peaks in the chromatogram obtained with the reference solution.

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. Although compressive force is applied to the tablet, along the diameter of the tablet at right angles to the applied force.

6.0)      Disintegration Time 

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.

7.0)      Dimension of Tablet:

Length, breadth and thickness are determined by vernier in mm

8.0)      Friability:

The test is applicable to compressed tablets and is intended to determine the physical strength of tablets. Tablets with a unit weight equal to or less than 650 mg, take a sample of whole tablets corresponding as near as possible to 6.5g. For tablets with a unit weight of more than 650mg, take a sample of 10 whole tablets. The tablets should be carefully dedusted prior to testing. Accurately weigh the tablet sample, and place the tablets in the drum. Rotate the drum 100 times and remove the tablets. Remove any loose dust from the tablets as before, and accurately weigh.

The test is run only once unless the results are difficult to interpret or if the weight loss is greater than the target value, in which case, the test is repeated twice and the mean of the three tests is determined.

          Formula: initial wt. – after friability wt. x100 / initial wt.

            A maximum loss of weight (From a single test or from the mean of three tests) not greater than 1.0 percent is acceptable for most tablets.

9.0)      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.

10.0)    Uniformity of content: (For Levocetirizine DiHCl)

            Determine by liquid chromatography, as under assay.

Test solution: Disperse one tablet to a 50ml volumetric flask with about 15ml of mobile phase, mix with aid of ultrasound and dilute to 50ml with the mobile phase, filter. Dilute with mobile phase to achieve desired concentration.

Reference solution: Weigh 25mg of Levocetirizine DiHCl reference standard in 50ml volumetric flask. Add 15ml of mobile phase and dissolve. Make upto the mark with same mobile phase. Dilute 5ml of this solution to 25ml with same mobile phase.

Calculate the content of levocetirizine DiHCl in the tablet.

11.0)    Assay: Determined by liquid chromatography.

Test solution: Weigh and powder 20 tablets. Weight a quantity of the powdered tablet containing 5mg of Levocetirizine DiHCl, add 20ml of mobile phase and dissolve by sonication and dilute to 100ml with mobile phase and filter. Dilute 5ml of this solution to 25ml with same mobile phase. Filter and inject the solutiuon.

Reference solution: Weigh 25mg of Levocetirizine DiHCl in 25ml of volumetric flask add mobile phase and dissolve. Take 60mg of Ambroxol HCl reference standard to 100ml volumetric flask. Add 20ml of mobile phase and 5ml of Levocetirizine DiHCl reference standard solution prepared previously and dissolve. Make upto the mark with mobile phase. Dilute 5ml of this solution to 25ml with same mobile phase. Filter and inject the solutiuon.

Chromatographic system:

  • A staianless steel column 25cmX4.6mm packed with octadecylsilane bonded to porous silica (5µm),
  • Mobile phase: 600 water and 400 water, 1ml of triethylamine and adjust the pH to 3.5 with O.P.A.
  • Flow rate: 1ml per minute,
  • Spectrophotometer set at 220nm,
  • Injection volume: 20µl

Inject reference solution. The test is not valid unless the tailing factor is not more than 2.0, the column efficiency is not less than 2000 theoretical plates. The relative standard deviation for replicate injections is not more than 2.0 per cent.

Inject reference solution and the test solution.

Calculate the content of Levocetirizine DiHCl and Ambroxol HCl in the tablet.

  Formula  for calculation: For Levocetirizine DiHCl)

Area of test   Weight of STD      5        5              100              25      Potency

  —————–X—————-X——X——X—————–X——X———-XAverage weight

Area of STD         25                100      25    Weight of test       5        100

Formula  for calculation: For Ambroxol HCl)

Area of test   Weight of STD      5              100              25      Potency

  —————–X—————–X——X—————–X——X———-XAverage weight

Area of STD         100                25      Weight of test     5        100

Acceptance criteria: 90.0%-110.0%


            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



Wt.: Weight

mg: Miligram

ml: Milileter

STD: Standard

inHg: Inch of Mercury

rpm: Rounds per minute

CFU: Colony forming unit

OPA: Orthophosphoric acid