Analysis of Isosorbide Mononitrate 20mg Tablets

TEST PROCEDURE / METHODS

standard testing procedure of Isosorbide Mononitrate 20mg 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 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 Dissolution Test: Apparatus No. 1,
Medium. 900 ml of 0.1 M hydrochloric acid,
Speed and time. 50 rpm and 30 minutes.
Withdraw 10 ml of the medium and filter promptly, rejecting the first few ml of the filtrate.
Determine by liquid chromatography.
Test solution. The filtrate obtained from the dissolution medium.
Reference solution. A solution of isosorbide mononitrate RS in the dissolution medium containing the same concentration of isosorbide mononitrate as that expected in the dissolution medium in the vessel.
Chromatographic system
– A stainless steel column 25 cm x 4.6 mm packed with octyldecylsilane bonded to porous silica (5 μm) (such as Spherisorb ODS 2),
– mobile phase: a mixture of equal volumes of methanol and water,
– flow rate 1 ml per minute,
– spectrophotometer set at 225 nm,
– injection volume: 100 μl.
Calculate the content of C6H9NO6. D.
Not less than 80 per cent of the stated amount of C6H9NO6.

Isosorbide mononitrate Estimation of Isosorbide Mononitrate By liquid chromatography

Chromatographic system
– A stainless steel column 25 cm x 4.6 mm packed with octyldecylsilane bonded to porous silica (5 μm) (such as Spherisorb ODS 2),
– mobile phase: a mixture of 30:70 volumes of methanol and water,
– flow rate 1 ml per minute,
– spectrophotometer set at 220 nm,
– injection volume: 20 μl.

Standard Preparation: Weight Accurately 100mg WS of Isosorbide Mononitrate in 100ml of VF dissolve in 70ml of Mobile phase and dilute to 100 ml with Mobile phase further dilute 10 ml in 100 ml of VF and make up to 100ml with Mobile phase.

Test Preparation: Cruses The 20 Tablets Weight Accurately Eq. to 100mg of Isosorbide Mononitrate in 100ml of VF sonicate to dissolve in 70ml of Mobile phase and dilute to 100ml with Mobile phase further dilute 10ml in 100ml of VF and make up to 100ml 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: