analysis of Finasteride 5mg Tablets

TEST PROCEDURE / METHODS

Standard testing procedure of Finasteride 5mg 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(Paddle),
Medium 900 ml water,
Speed and time. 50 rpm & 45 minutes.
Test solution: Withdraw a suitable volume of the medium and filter.
Determine by liquid chromatography.

Reference solution: Dissolve a weighed 55mg quantity of finasteride RS in a mixture of 3 volumes of water and 7 volumes of acetonitrile and dilute with the same mixture to obtain a solution in 100ml of VF further dilute 2ml in 200ml of VF in dissolution medium.

Chromatographic system
– a stainless steel column 5.0 cm x 4.6 mm, packed with
octadecylsilane bonded to porous silica (3 μm),
– column temperature. 45º,
– mobile phase: a mixture of 42 volumes of water and
58 volumes of acetonitrile,
– flow rate: 1.5 ml per minute,
– spectrophotometer set at 220 nm,
– injection volume: 200 μl.

After saturation of column Separately inject the 20µl of Standard & Test solution. record the chromatogram and measure the peak response with the reference chromatogram

07 Uniformity of content: Determine by liquid chromatography,

Chromatographic system
– a stainless steel column 10 cm x 4.6 mm, packed with octadecylsilane bonded to porous silica (5 μm) (such as Hypersil ODS),
– column temperature. 45º,
– mobile phase: a mixture of equal volumes of acetonitrile and 0.0025 M of orthophosphoric acid,
– flow rate: 1.5 ml per minute
– spectrophotometer set at 240 nm,
– injection volume: 20 μl.

Inject the reference solution. The test is not valid unless the tailing factor of the principal peak is less than 2.0 and the relative standard deviation for replicate injections is not more than 2.0.
Inject the reference solution and the test solution.

Test solution: Powder one tablet, add 2.5 ml of water, shake with the aid of ultrasound until the tablet is completely dispersed. Add 35 ml of a mixture of 3 volumes of water and 7 volumes of acetonitrile, mix with the aid of ultrasound for a further 30 minutes. Cool to room temperature, dilute to 50 ml with acetonitrile, centrifuge and filter the supernatant liquid.

Standard Preparation: Weight Accurately 50 mg WS of Finasteride in 100ml of VF dissolve in a mixture of 3 volumes of water and 7 volumes of acetonitrile further dilute 10ml in 50ml of VF and make up to 50ml with 3 volumes of water and 7 volumes of acetonitrile

Calculate the content of C23H36N2O2 in the tablet.
08 Assay
Finasteride-5mg Estimation of Finasteride By HPLC
Chromatographic system
– a stainless steel column 10 cm x 4.6 mm, packed with octadecylsilane bonded to porous silica (5 μm) (such as Hypersil ODS),
– column temperature. 45º,
– mobile phase: a mixture of equal volumes of acetonitrile and 0.0025 M of orthophosphoric acid,
– flow rate: 1.5 ml per minute
– spectrophotometer set at 240 nm,
– injection volume: 20 μl.
Inject the reference solution. The test is not valid unless the tailing factor of the principal peak is less than 2.0 and the relative standard deviation for replicate injections is not more than 2.0.
Inject the reference solution and the test solution.
Standard Preparation: Weight Accurately 50 mg WS of Finasteride in 100ml of VF dissolve in a mixture of 3 volumes of water and 7 volumes of acetonitrile further dilute 10ml in 50ml of VF and make up to 50ml with 3 volumes of water and 7 volumes of acetonitrile.

Test Preparation: Cruses The 20 Tablets & Weight Accurately Equivalent to 50 mg of Finasteride in 100ml of VF dissolve in a mixture of 3 volumes of water and 7 volumes of acetonitrile further dilute 10ml in 50ml of VF and make up to 50ml with 3 volumes of water and 7 volumes of acetonitrile

After saturation of column Separately inject the 20µl of Standard & Test solution. record the chromatogram and measure the peak response with the reference chromatogram

Inject the reference solution. The test is not valid unless the tailing factor of the principal peak is less than 2.0 and the relative standard deviation for replicate injections is not more than 2.0.