analysis of Topiramate 50 mg
TEST PROCEDURE / METHODS
standard testing procedure of Topiramate 50 mg
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 400 mm (15”) of mercury. The vacuum should be maintained for 120 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. 500 ml of Water
Speed and time. 50 rpm and 45 minutes.
Reference solution. Add 50 mg of Topiramate WS in 500 ml of dissolution medium & run simultaneously with tablets
After saturation of column Separately inject the 100 µl of Standard & Test solution. record the chromatogram and measure the peak response with the reference chromatogram
Chromatographic system
– A stainless steel column 25 cm x 4.6 mm packed with Octyldecylsilane bonded to porous silica (5μm),
– mobile phase: a mixture of 50 volumes of ACN & 50 volume Water
– flow rate 1 ml per minute,
-Colam temperature-50
– Refractive index detector(Detector cell temperature 50°)
– injection volume: 100 μl.
Not less than 70 per cent of the stated amount of Topiramate.
Assay :– Topiramate-50mg Estimation of Topiramate By liquid chromatography
Chromatographic system
– A stainless steel column 25 cm x 4.6 mm packed with Octyldecylsilane bonded to porous silica (5μm),
– mobile phase: a mixture of 50 volumes of ACN & 50 volume Water
– flow rate 1 ml per minute,
– Refractive index detector(Detector cell temperature 50°)
– Injection volume: 100 μl.
Standard Preparation: Weight Accurately 100mg WS of Topiramate in 100ml of VF dissolve in 70ml of Mobile phase and make up the 100 ml with Mobile.
Test Preparation: Cruses The 20 Tablets Weight Accurately Eq. to 100mg of Topiramate in 100ml of VF sonicates to dissolve in 70ml of Mobile phase & and dilute up to 100ml with Mobile phase.
.
After saturation of column Separately inject the 100µl of Standard & Test solution. record the chromatogram and measure the peak response with the reference chromatogram
Calculation:
(Calculate the result of labeled amount of Topiramate, Since the labeled amount of Topiramate is 50mg.
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