Analysis of Ivabradine 5 mg Tablet

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.

Assay- Ivabradine-5 mg Estimation of Ivabradine By liquid chromatography

Chromatographic system
– A stainless steel column 25 cm x 4.6 mm packed with octyldecylsilane bonded to porous silica (5 μm)
– Mobile phase: a mixture of 55:45:0.1 volumes of water, methanol and Triethylamine pH-4.0 with H3PO4,
– flow rate 1 ml per minute,
– spectrophotometer set at 285nm,
– injection volume: 20 μl.

Standard Preparation: Weight Accurately 100mg WS of Ivabradine HCl in 100ml of VF dissolve in 70ml of Mobile phase and dilute to 100 ml with Mobile phase further dilute 10 ml in 50 ml of VF and make up to 50ml with Mobile phase.

Test Preparation: Cruses The 20 Tablets Weight Accurately Eq. to 20 mg of Ivabradine in 100ml of VF sonicate to dissolve in 70ml of Mobile phase and dilute 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: