Inositol Nicotinate Tablets
Action and use
Vasodilator.
Definition
Inositol Nicotinate Tablets contain Inositol Nicotinate.
Content of inositol nicotinate, C42H30N6O12
95.0 to 105.0% of the stated amount.
Identification
Shake a quantity of the powdered tablets containing 1 g of Inositol Nicotinate with 30 mL of a mixture of 9 volumes of chloroform and 1 volume of methanol, filter and evaporate to dryness. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of inositol nicotinate (RS 190). Retain the remainder of the residue for use in the Related substances test.
Tests
Dissolution
Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.
Calculate the total content of inositol nicotinate, C42H30N6O12, in the medium taking 398 as the value of A(1%, 1 cm) at the maximum at 262 nm.
Free nicotinic acid
To a quantity of the powdered tablets containing 1 g of Inositol Nicotinate add 75 mL of water, shake for 15 minutes and titrate with 0.02m sodium hydroxide VS using phenolphthalein solution R1 as indicator. Not more than 1.0 mL of 0.02m sodium hydroxide VS is required to produce the first pink colour.
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
For the first development: 10 volumes of methanol and 90 volumes of chloroform.
For the second development: 5 volumes each of glacial acetic acid, ethanol (96%) and water and 50 volumes of ethyl acetate.
Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (1.5%) and not more than one such spot is more intense than the spot in the chromatogram obtained with solution (3) (1%).
Assay
Weigh and powder 20 tablets. To a quantity of the powdered tablets containing 0.25 g of Inositol Nicotinate add 50 mL of anhydrous acetic acid, heat to boiling and allow to cool. Carry out Method I for non-aqueous titration, Appendix VIII A, using 1-naphtholbenzein solution as indicator. Each mL of 0.1m perchloric acid VS is equivalent to 13.51 mg of C42H30N6O12.