Analysis of Hydroxychloroquine Sulphate Tablets

TEST PROCEDURE / METHODS

Standard testing procedure Hydroxychloroquine Sulphate 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

Shake a quantity of the powdered tablets containing 0.1 g of Hydroxy chloroquine Sulphate with 10 ml of water and filter. To the filterate add 1 ml of 2M hydrochloric acid and 1 ml of barium chloride solution. A white precipitate is produced.
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 water,
Speed and time. 50 rpm and 45 minutes.
Withdraw a suitable volume of the medium and filter, dilute if necessary with the dissolution medium and measure the absorbance of the resulting solution at the maximum at about 343 nm. Calculate the content of C18H26ClN3O, H2SO4 in the medium from the absorbance obtained from a solution of
known concentration of Hdroxychloroquine sulphate WS in the same medium.

D. Not less than 75 per cent of the stated amount of C18H26ClN3O, H2SO4.

Hdroxychloroquine sulphate-200mg Estimation of Hdroxychloroquine sulphate By UV Spectrophotometer

Standard Preparation: Weight Accurately 50mg WS of Hdroxychloroquine sulphate in 100ml of VF dissolve in 70ml of water and dilute to 100ml with water further dilute 2ml in 100ml of VF and make up to 100ml with water.

Test Preparation: Cruses The 20 Tablets Weight Accurately Eq. to 50mg of Hdroxychloroquine sulphate in 100ml of VF sonicate to dissolve in 70ml of water and dilute to 100ml with water further dilute 2ml in 100ml of VF and make up to 100ml with water.

And measure the absorbance by UV & Vis Spectrophotometer at 343 nm and calculate the results by comparison.

Sample Std Wt.