Nicotinyl Alcohol Tablets
Action and use
Vasodilator.
Definition
Nicotinyl Alcohol Tablets contain Nicotinyl Alcohol Tartrate.
Content of nicotinyl alcohol tartrate, C6H7NO,C4H6O6
92.5 to 107.5% of the stated amount.
Identification
In the test for Related substances, the principal spot in the chromatogram obtained with solution (2) corresponds to that in the chromatogram obtained with solution (4).
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using silica gel GF254 as the coating substance and a mixture of 4 volumes of 13.5m ammonia, 16 volumes of methanol, 30 volumes of 1,4-dioxan and 50 volumes of dichloromethane 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 0.25 g of Nicotinyl Alcohol Tartrate with 50 mL of methanol, filter and evaporate the filtrate to dryness at about 30° at a pressure of 2 kPa. Add 2 mL of water to the residue, shake, filter and add 0.1 mL of 13.5m ammonia to the filtrate. For solution (2) dilute 1 volume of solution (1) to 500 volumes with 0.1m ammonia. Solution (3) contains 0.025% w/v of 3-(aminomethyl)pyridine in 0.1m ammonia. Solution (4) contains 0.025% w/v of nicotinyl alcohol tartrate BPCRS in 0.1m ammonia. After removal of the plate, allow it to dry in air and examine under ultraviolet light (254 nm). Spray with a 2% w/v solution of chloro-2,4,6-trinitrobenzene in absolute ethanol, dry in a current of air and spray with a 5% w/v solution of sodium carbonate. In the chromatogram obtained with solution (1), any spot corresponding to 3-(aminomethyl)pyridine is not more intense than the spot in the chromatogram obtained with solution (3) (0.2%) and any other secondary spot is not more intense than the spot in the chromatogram obtained with solution (2) (0.2%). Disregard any spot due to tartaric acid remaining on the line of application.
Assay
Weigh and powder 20 tablets. Shake a quantity of the powder containing 50 mg of Nicotinyl Alcohol Tartrate with 150 mL of 0.1m hydrochloric acid for 10 minutes, dilute to 250 mL with the same solvent, mix and filter. Dilute 10 mL of the filtrate to 100 mL with 0.1m hydrochloric acid and measure the absorbance of the resulting solution at the maximum at 261 nm, Appendix II B. Calculate the content of C6H7NO,C4H6O6 taking 210 as the value of A (1%, 1 cm) at the maximum at 261 nm.