## STP For Citicoline Sodium and Piracetam Tablets

Sr.NO. TEST PROCEDURE
1.0 Description Red color, elongated, biconvex, film coated Tablets.
2.0 Identification

(By HPLC)

In the Assay, the principal peak in the chromatogram obtained with the test solution corresponds to the principal peak in the chromatogram obtained with the reference solution.
3.0 Average weight Weigh 20 tablets selected at random and calculate the average weight by following formula.

Weight of 20 tablets

Average weight = ———————————

20

4.0 Uniformity of weight Weigh 20 tablets selected at random and calculate the average weight. Weigh individually, not more than two of the individual weights deviate from the average weight by more than the percentage shown in Table and none deviates by more than twice that percentage.

 Table Average weight of tablet Percentage deviation More than 250 mg ±5.0

Calculation formula for uniformity of weight is given below:

W1 – W

—————— x 100

W

Where,

W1= Minimum or maximum weight (in mg) of tablets found in 20 tablets,

W= Average weight of 20 tablets in mg.

5.0 Disintegration Time The Disintegration apparatus consist of a basket-rack assembly, a 1-liter beaker, a thermostatic arrangement for heating the fluid, bath tray and a mechanical device for raising and lowering the basket in the immersion fluid at a constant frequency rate.

Introduce one tablet into each tube and then add disc to each tube. Suspend the assembly in the beaker container the water at 37ºC±2ºC and operate the apparatus for 15 minutes and examine the state of the 6 tablets. If any of the tablets has not disintegrated, repeat the test on a further 12 tablets. The tablets comply with the test if 16 tablets out of total 18 tablets have disintegrated. If tablets fail to comply because of adherence to the discs, repeat the test omitting the discs.

6.0

Assay (By HPLC) Determination of Citicoline and Piracetam :

Sample preparation: Weigh and powder 20 tablets. Weigh accurately a quantity of the powdered tablet containing 25 mg of Citicoline and 40 mg of Piracetam in 100 ml volumetric flask, add 60 ml mobile phase and sonicate for 10 minutes, cool and dilute to 100 ml with mobile phase. Further dilute 1 ml of the solution to 10 ml with mobile phase.

Standard Preparation:Weight and dissolve 25 mg of Citicoline and 40 mg of Piracetamworking standard in 100 ml mobile phase. Further dilute 1 ml of the solution to 10 ml with mobile phase

Chromatographic system

 Column C18 (250×4.6mm, 10µl) column was used as a stationary phase. Column Temperature 35°C Mobile phase A mixture of Buffer (0.01M KH2PO4 pH adjusted to 3.5 with orthophosphoric acid) and methanol in the ratio of 90:10 (v/v) was used in the analysis. Flow rate 0.8 ml/min Detecting wavelength 210 nm Injection volume 20 µl

Sequence Table:

1.      Blank

2.      Standard Solution (1,2,3,4 & 5 injection)

3.      Test Solution 1

4.      Test Solution 2

5.      BKT Standard

Calculation for Citicoline:

Sample Area X Std. wt. (mg) X1 X 100 X 10 X Avg. Wt. of (mg) X Purity

Calculation= ———————————————————————————

Std. Area X 100 X 10X Sample wt. (mg) X 1 X 100

= …….. mg

% =       mg X 100

Label Claim

Calculation for Piracetam:

Sample Area X Std. wt. (mg) X 1 X 100 X 10 X Avg. Wt. of (mg) X Purity

Calculation= ————————————————————————-

Std. Area X 100 X 10 X Sample wt. (mg) X 1 X 100

= …….. mg

% =       mg X 100

Label Claim

Inject the standard solution. The test is not valid unless the tailing factor is not more than 2.0. The relative standard deviation for replicate injections is not more than 2.0 %.