Analysis of Memantine HCl 10mg Tablets

TEST PROCEDURE / METHODS

Standard testing procedure of Memantine HCl 10mg 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 peak maxima in the chromatogram obtained with the test solution corresponds to the peak maxima of Memantine HCl in the chromatogram obtained with the reference solution due to scaning 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 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 Assay-Memantine HCl-10
mg Estimation of Memantine HCl By UV-Vis Spectrophotometer

Standard Preparation: Weight Accurately 50 mg WS of Memantine HCl in 100ml of VF sonicate to dissolve in 70ml of water and dilute to 100ml with water, pipette out 2ml in 250ml of SF add 2ml of eosin in same SF add 15ml of chloroform three time to extract and pass with anhydrous Sodium sulphate in a 50ml of dry VF & make up to 50 with chloroform.

Test Preparation: Cruses The 20 Tablets Weight Accurately Eq. to 50 mg of Memantine HCl in 100ml of VF sonicate to dissolve in 70ml of water and dilute to 100ml with water, pipette out 2ml in 250ml of SF add 2ml of eosin in same SF add 15ml of chloroform three time to extract and pass with anhydrous Sodium sulphate in a 50ml of dry VF & make up to 50 with chloroform.

Measure the absorbance of the resulting solution at the maximum at about 371 nm. Calculate the content of Memantine HCl by comparison.

Calculation for Memantine HCl:

Analysis of Memantine HCl 10mg Tablets

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