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Test Method for Vitamin B Complex Tablets

B vitamins play a vital role in maintaining good health and well-being. As the building blocks of a healthy body, B vitamins have a direct impact on your energy levels, brain function, and cell metabolism. Vitamin B complex helps prevent infections and helps support or promote: cell health.



Vitamin B Complex Tablets Contains:

Thiamine Hydrochloride : 1 mg / tablet
Riboflavin :- 1 mg / tablet
Niacinamide :- 10 mg / tablet

Assay By HPLC

Chromatographic Condition

Mobile Phase Preparation: Water : Methanol : Acetonitrile : Glacial Acetic Acid ( 75 : 16.5 : 7 : 0.8, v/v) containing 140 mg of Sodium Hexane Sulphonate per 100 ml.
Diluting solution : Water: Acetonitrile : Glacial Acetic Acid (94 : 5 : 1) containing 140 mg of Sodium Hexane Sulphonate per 100 ml.
Flow rate : 1.0 ml/min
Detector : 280 nm
Injection volume : 20 μl
Temperature : 30 °C
Column : C8, 4.6 × 250 mm. 5 µm.

Standard Preparation:
Weigh accurately 20 mg of Thiamine hydrochloride working standard, 20 mg of Riboflavin working standard & 200 mg Niacinamide working standard & transferred in to 200 ml volumetric flask, add 180 ml diluent & mix well. Immerse the volumetric flask in a hot water bath maintained at 65°C to 70°C for about 10 minutes with regular shaking until the material is dissolved. Chill rapidly in a cold water bath for 10 minutes to room temperature, dilute with diluting solution to volume & mix.


Sample Solution:
Weigh & powder 50 tablets, weigh 2.0 g of powder tablet equivalent to 20mg of Thiamine hydrochloride, 20mg of Riboflavin & 200mg Niacinamide & transferred in to 200ml volumetric flask, add 180ml diluent & mix well. Immerse the volumetric flask in a hot water bath maintained at 65°C to 70°C for about 10 minutes with regular shaking until the material is dissolved. Chill rapidly in a cold water bath for 10 minutes to room temperature, dilute with diluting solution to volume & mix. Filter with 0.45 µ filter.

Develop the chromatogram using the above HPLC conditions. The relative standard deviation for replicate injections is not more than 3 %.

Calculation:



Limit:
Thiamine HCl :- 0.90 – 1.50 mg / tablet
Riboflavin :- 0.90 – 1.50 mg / tablet
Niacinamide :- 9.0 – 15.0 mg / tablet

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