Analysis of Fexofenadine and Montelukast Tablets

TESTS TEST PROCEDURE / METHODS

01. Description Remove 20 tablets from the strip. Place on a white paper and observe visually.

02. Average Weight Weigh accurately 20 tablets and calculate the average weight.
Average Weight = Weight of 20 tablets/20

03. Uniformity of weight variation Weigh 20 tablets selected at random and determine the average weight. Weigh 20 tablets individually & record. Not more than two of the individual weights deviate from the average weight by more than 7.5 % and none deviates by more than 15 %.

04. Identification

In the assay, the principle peak in the chromatogram obtained with the test solution corresponds to the peak in the chromatogram obtained with reference solution.

05 Leak test Equipment:
a) A vacuum Desiccator.
b) A vacuum pump with gauge.
Procedure: Take 3 strips and keep in vacuum desiccator. Ensure that strips are immersed in water. Connect the desiccator to vacuum pump with rubber tube and apply vacuum about 381 mm (15”) of mercury. The vacuum should be maintained for 30 sec. Release vacuum. Remove the strips wipe and dry with a clean cloth cut the strip and examine carefully. None of the tablets should be sticky or moist.

06 Disintegration Test Place six tablets one each in six tubes of the basket in a suitable disintegration test apparatus. Previously suspend the assembly in water (about 750-800 ml) maintained at a temperature of 37˚C ± 1˚C and operate the apparatus with disc to each tube. The tablets pass the test, if all the tablets have disintegrate (no residue of the tablet remains on the screen of the apparatus or, if a residue remains, it consists of fragments of insoluble coating of the tablets or is a soft mass with no palpable core) in 30 minutes. 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 being examined fails to comply, repeat the test omitting the disc.
7.0 Uniformity of Content Use the chromatographic condition of assay to perform the analysis of Montelukast Uniformity of content.

Stock solution of Montelukast sodium: Weight Accurately 108 mg of Montelukast sodium in100ml of VF dissolve in 70ml of Methanol and dilute 10ml in 100 ml of VF with methanol & make upto 100ml with methanol.

Standard Preparation: Pipette out 10ml of Stock solution of Montelukast sodium final dilution in 50ml of VF make upto 50ml with mobile phase

Test Preparation: add ten tablets in 10 VF of 100ml separately, sonicate to dissolve the tablet in 70ml of methanol and dilute to 100 ml with Methanol further dilute 10 ml in 50ml of VF and make up to 50ml with mobile phase.

After saturation of column Separately inject the 20µl of Standard & Test solution. Record the chromatogram and measure the peak response with the reference chromatogram.

Calculation for Montelukast sodium:

8.0 Assay-Fexofenadine-120 mg & Montelukast-10mg Estimation of Fexofenadine & Montelukast By liquid chromatography
Chromatographic system
– A stainless steel column 25 cm x 4.6 mm packed with octylsilane bonded to porous silica (5μm)
– mobile phase: a mixture of 25:10:65 volumes of Buffer, methanol, Acetonitrile,
– flow rate 1 ml per minute,
– spectrophotometer set at 220 nm,
– injection volume: 20 μl.

Buffer Preparation: 385 mg of Ammonium Acetate in 100ml of HPLC water & 0.1ml of Triethylamine and adjust the pH- 4.20 with dilute Glacial acetic acid.

Stock solution of Fexofenadine: Weight Accurately 120 mg WS of Fexofenadine in100ml of VF, dissolve in 70ml of Methanol & make up the 100ml with methanol

Standard Preparation: Pipette out 10ml of each Stock solution of Fexofenadine & Stock solution of Montelukast sodium final dilution in 50ml of VF make upto 50ml with mobile phase

Test Preparation: Cruses The 20 Tablets Weight Accurately Eq. to 120 mg of Fexofenadine in 100ml of VF sonicate to dissolve in 70ml of methanol and dilute to 100ml with Methanol further dilute 10ml in 50ml of VF and make up to 50ml with mobile phase.

After saturation of column Separately inject the 20µl of Standard & Test solution. record the chromatogram and measure the peak response with the reference chromatogram