Meptazinol Tablets
Action and use
Opioid receptor partial agonist; analgesic.
Definition
Meptazinol Tablets contain Meptazinol Hydrochloride.
Content of meptazinol, C15H23NO
95.0 to 105.0% of the stated amount.
Identification
1 volume of 18m ammonia, 20 volumes of absolute ethanol and 79 volumes of toluene.
The principal spot in the chromatogram obtained with solution (1) corresponds in intensity, position and size to that in the chromatogram obtained with solution (2).
TEST
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions in ethanol (96%).
1 volume of 18m ammonia, 30 volumes of chloroform and 70 volumes of ethyl acetate.
By each method of visualisation, 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%) and not more than one such spot is more intense than the spot in the chromatogram obtained with solution (3) (0.5%).
Assay
To a quantity of the powdered tablets containing the equivalent of 0.2 g of meptazinol add 40 mL of 0.06m hydrochloric acid, shake, dilute to 50 mL with the same solvent, filter through a glass-fibre paper (Whatman GF/C paper is suitable); dilute 5 mL of the filtrate to 250 mL with 0.06m hydrochloric acid and measure the absorbance of the resulting solution at the maximum at 273 nm, Appendix II B. Calculate the content of C15H23NO from the absorbance obtained using a 0.0080% w/v solution of meptazinol hydrochloride BPCRS in 0.06m hydrochloric acid and from the declared content of C15H23NO in meptazinol hydrochloride BPCRS.
Labelling
The quantity of active ingredient is stated in terms of the equivalent amount of meptazinol.