Analyses of Mesalamine Delayed Release Tablets

TEST PROCEDURE / METHODS

Standard testing procedure of Mesalamine Delayed Release Tablets

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 5 % and none deviates by more than 10 %.

04. Identification

In the Assay, the peak maxima in the chromatogram obtained with the test solution corresponds to the peak maxima due to misalamine in the chromatogram obtained with the reference solution due to scanning on UV & Vis Spectrophotometer.

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 Dissolution :Test Acid-Stage
Apparatus No. 1(Paddle)
Medium. 500 ml of 0.1HCl,
Speed and time. 100 rpm for 120 minutes.
Withdraw a suitable volume of the medium and filter. Determine by UV & Vis Spectrophotometer
Test solution. Use the filtrate.
Reference solution. A 0.002 per cent w/v solution of Mesalamine WS in dissolution medium.
Use UV & Vis Spectrophotometer system to take the absorbance at 302nm.
Calculate the content of Mesalamine.
D. Not more than 10 per cent of the stated amount of Mesalamine.

Buffer-Stage-I
Apparatus No. 1, (Paddle)
Medium. 900 ml of phosphate buffer pH-6.0 (Prepare by using 42.3gm of KH2PO4 & 1.65gm NaOH to 2litter Volumetric Flask)
Speed and time. 100 rpm for 60 minutes.
Run the dissolution with tablet used in the acid-stage after drying with tissue paper, Withdraw 50ml aliquot and filter, Determine by UV & Vis Spectrophotometer immediately.
Test solution. Use the filtrate.
Reference solution. A 0.002 per cent w/v solution of Mesalamine WS in dissolution medium.
Use UV & Vis Spectrophotometer system to take the absorbance at 330nm.
Calculate the content of Mesalamine.
D. Not more than 10 per cent of the stated amount of Mesalamine.

Buffer-Stage-II
Sodium Hydroxide Solution: 133.6gm NaOH to a 2 liter VF & dilute to water.
Apparatus No. 1, (Paddle)
Medium: As such medium used in buffer stage-I by adding 50ml of Sodium Hydroxide Solution & check the pH-7.2.
Speed and time. 50 rpm for 90 minutes.
Run the dissolution with tablet used in the buffer stage-I, Withdraw a suitable volume of the medium and filter. Determine by UV & Vis Spectrophotometer
Test solution. Use the filtrate.
Reference solution. A 0.002 per cent w/v solution of Mesalamine WS in dissolution medium.
Use UV & Vis Spectrophotometer system to take the absorbance at 332nm.
Calculate the content of Mesalamine.

D. Not less than 80 per cent of the stated amount of Mesalamine.

7.0 Assay :
Mesalamine-400mg Estimation of Mesalamine By UV Spectrophotometer

Standard Preparation: Weight Accurately 100mg WS of Mesalamine in 100ml of VF dissolve in 70ml of 0.1N NaOH and dilute to 100 ml with 0.1N NaOH further dilute 2ml in 100 ml of VF and make up to 100ml with 0.1N HCl.

Test Preparation: Cruses The 20 Tablets Weight Accurately Eq. to 50mg of Mesalamine in 100ml of VF sonicate to dissolve in 70ml of 0.1N NaOH and dilute to 100ml with 0.1N NaOH further dilute 2ml in 100ml of VF and make up to 100ml with 0.1N HCl.

Analyses of Mesalamine Delayed Release Tablets

Leave a Comment Cancel reply