analysis of repaglinide tablets

TEST PROCEDURE / METHODS

standard testing procedure of repaglinide 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,

Medium. 900 ml of pH-5.0 Buffer prepared by mixing 10.2gm citric acid monohydrate and 18.16gm of dibasic sodium phosphate dihydrate with 1liter
Speed and time. 75rpm and 30 minutes.

Test Solution: Withdraw 10ml of the medium promptly in 25 ml of VF add mobile phase & make-up the mark.

Reference solution. Pipette out 1ml of the final dilution of STD solution in 25 ml of VF, add 10ml of dissolution medium and make-up to the mark with mobile phase.

Chromatographic system
Use the chromatographic system described in the Assay.

Assay- Repaglinide-2mg Estimation of Repaglinide By liquid chromatography

Chromatographic system
– A stainless steel column C18 25 cm x 4.6 mm, 5micron.
– mobile phase: a mixture of 10 volumes of Buffer & 90 volume methanol
– flow rate 1.2 ml per minute,
– spectrophotometer set at 245 nm,
– Injection volume: 20 μl.

Buffer Preparation: 200 mg of Ammonium dihydrogen orthophosphate in 100ml of water adjust pH-2.5 with 1% w/v of Phosphoric acid.

Standard Preparation: Weight Accurately 50mg WS of Repaglinide 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 5 mg of Repaglinide in 100ml of VF sonicates to dissolve in 70ml of Mobile phase and dilute to 100ml with Mobile phase.

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: