stp for Acarbose-25mg Tablets

TESTS 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 Dissolution

Test Apparatus No. 1,

Medium. 500 ml
Buffer prepared by mixing 136gm Potassium Dihydrogen Phosphate 2ml of triethylamine pH-3.0 OPA in 1liter
Speed and time. 100rpm and 30 minutes.

Test Solution: Withdraw 10ml of the medium promptly to run the sample in saturated chromatographic system.

Reference solution. Pipette out 25ml of the final dilution of STD solution in 50 ml of VF, add dissolution medium up to the mark.

Chromatographic system
Use the chromatographic system described in the Assay.

Assay- Acarbose-25mg Estimation of Acarbose By liquid chromatography

Chromatographic system
– A stainless steel column C8 25 cm x 4.6 mm, 5micron.
– Mobile phase: a mixture of 96 volumes of Buffer & 4volume Acetonitrile.
– flow rate 1.0 ml per minute,
– spectrophotometer set at 210 nm,
– Injection volume: 20μl.

Buffer Preparation: 128mg Potassium dihydrogen orthophosphate in 100ml of water adjust pH-6.90 with 1M NaoH.

Standard Preparation: Weight Accurately 50mg WS of Acarbose in 100ml of VF dissolve in 70ml of Mobile phase & pipette out 10ml and dilute to 100 ml with Mobile in 100ml of VF.

Test Preparation: Cruses The 20 Tablets Weight Accurately Eq. to 100 mg of Acarbose in 100ml of VF sonicates to dissolve in 70ml of Mobile phase and dilute to 100ml with Mobile phase & pipette out 10ml and dilute to 100 ml with Mobile in 100ml of VF

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:

Spl. Area Std. Wt. 10 100 10 Potency
————-X————X——–X———-X————X————X Avg. wt.
Std Area 100 100 Spl. Wt. 100 100

(Calculate the result of labeled amount of Acarbose, Since the labeled amount of Acarbose is 25mg.

Abbreviations:
OPA; Orthophosphoric Acid
WS- working standard
SF-Separating Funnel
VF-Volumetric Flask
Std-Standard
Spl-Sample