STP for Ferrous Ascorbate and Folic Acid Suspension

nirvesh400

1.) Description: A Black colored liquid; filled volume in amber colored pet bottle.

2.) Identification: To be confirmed by assay of all the active ingredients.

3).  Average fills volume: Not less than labeled claim.

Take 10 bottles and measure the volumes of separately each all bottle with calibrated or certified volumetric flask.

4.) PH: Between 3.5 to 5.5

5.) Content of active ingredients:

ASSAY OF ACTIVE INGREDIENTS:

(3.1)Ferrous Ascorbate eq. to Elemental Iron:  10mg/ ml

Reagents :-

  1. 20 % w/v solution of citric acid.
  2. Strong ammonia solution.
  3. 80%Thioglycolic acid.
  4. Concentrated hydrochloric acid.

Standard solution :-

To accurately weight std. 150mg Ferrous Ascorbate Equivalent to 30.0mg iron adds 10 ml of concentrated hydrochloric acid and dilute to 100ml with water. Further dilute 5ml to 100 ml with water.

Sample solution:-

To appropriate quantity of sample3ml of sample (eq. to 30.0mg iron) add 10 ml of concentrated hydrochloric acid and dilute to 100ml with water. Further dilute 5ml to 100 ml with water.

Procedure :-

To 5 ml each of sample and standard  solutions add 2ml  of citric acid solution, 0.1 ml of thioglycollic acid and 5ml of strong ammonia, dilute to 50 ml with water . Measure the absorbance of both the solution at 525 nm against reagent blank. This  will give total quantity ( mg) of iron in the sample.

Calculation: – Iron

Sample . ABS.     X  Std.Wt.      X    5       X      5         X    100  X      100  X  5       X  Potency                                                                Std. ABS        X   100        X  100    X       50      X     3     X         5  X 50

(B)FOLIC ACID IP 100mcg /ml

Mobile phase: Buffer (930ml)  + Acetonitrile (70 ml)

Buffer: 6.8gm of Potassium Dihydrogen ortho-phsophate in 1000ml of water. Adjust the pH 6.8 with ortho-phosphoric acid.

Column: C18

Flow rate: 1.5ml/ Min.

Standard Preparation:

56mg of folic acid working standard add 10 ml of 0.1M Sodium Hydroxide. Sonicate for 10min. make up to 100ml with Mobile phase.   2 ml of above solution in 50ml v.f.add 10ml of 0.1M Sodium hydroxide. Make to 50ml with mobile phase.

Test Preparation:

10ml of test solution in 50ml v.f. add 10ml of 0.1M Sodium hydroxide. And make up to mark with mobile phase.

Calculation: – Folic acid

 

Sample . ABS.     X  Std.Wt.   X  2      X  50   X  Potency    x  1                                                                                     Std. ABS       X         100      X 50     X  10

 

 

 

 

 

 

STP