Pyridoxine Tablets
Action and use
Vitamin B6.
Definition
Pyridoxine Tablets contain Pyridoxine Hydrochloride.
Content of pyridoxine hydrochloride, C8H11NO3,HCl
90.0 to 110.0% of the stated amount.
Identification
Tests
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using silica gel G as the coating substance and a mixture of 9 volumes of 13.5m ammonia, 13 volumes of tetrahydrofuran, 13 volumes of dichloromethane and 65 volumes of acetone as the mobile phase. Apply separately to the plate 10 µL of each of the following solutions. For solution (1) shake a quantity of the powdered tablets containing 40 mg of Pyridoxine Hydrochloride with 10 mL of water for 15 minutes, filter and use the filtrate. For solution (2) dilute 1 mL of solution (1) to 200 mL with water. After removal of the plate, allow it to dry in air and spray with a 5% w/v solution of sodium carbonate in ethanol (30%). Allow the plate to dry in air, spray with a 0.1% w/v solution of 2,6-dichloroquinone-4-chloroimide in ethanol (96%) and examine immediately. Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (0.5%). Disregard any spot remaining on the line of application.
Assay
Weigh and powder 20 tablets. To a quantity of the powdered tablets containing 25 mg of Pyridoxine Hydrochloride add 50 mL of 0.1m hydrochloric acid and heat on a water bath for 15 minutes, swirling occasionally. Cool, dilute to 100 mL with 0.1m hydrochloric acid and filter, discarding the first 20 mL of filtrate. Dilute 5 mL of the filtrate to 100 mL with 0.1m hydrochloric acid and measure the absorbance of the resulting solution at the maximum at 290 nm, Appendix II B. Calculate the content of C8H11NO3,HCl taking 430 as the value of A(1%, 1 cm) at the maximum at 290 nm.
Storage
Pyridoxine Tablets should be protected from light and stored at a temperature not exceeding 30°.
When vitamin B6 tablets are prescribed or demanded, Pyridoxine Tablets shall be dispensed or supplied.