Saccharin Initial Assay
Added, m g Final Assay Recovery, % Tablet Tablet Suspension Suspension Elixir Elixir 16.9 mg/tablet 4 . 8 21.7 mg/tablet 100 3 2 . 6 mg/tablet 9 . 3 42.0 mg/tablet 100 3 . 8 mg/5 ml 5.5 9 . 1 mg/5 ml 98 3 . 8 mg/5 m l 1 0 . 2 13.6 mg/5 ml 97
5 . 1 mg/tablet 5 . 1 10.5 mg/5 ml 103 5.1 mg/5 m l 10.5 1 6 . 3 mg/5 ml 105
Interferences-To establish the applicability of this procedure to various pharmaceutical dosage forms, synthetic formulations were made by adding sodium saccharin and were analyzed in addition to commercially available products. By the use of saccharinfree placebo formulations, it was found that pharmaceutically active ingredients such as ascorbic acid, nicotinyl alcohol, aprobarbital, dextromethorphan hydrobromide, chlorpheniramine maleate, acetaminophen, and sulfamethoxazole did not interfere with the analysis.
One pharmaceutical product contained a vitamin B-complex mixture made up of thiamine mononitrate, riboflavin phosphate, pyridoxine hydrochloride, niacinamide, and calcium pantothenate. The ingredients in the mixture did not cause any interference. Commonly used pharmaceutical excipients such as corn syrup, sucrose, citric acid, sodium citrate, sodium benzoate, propylene glycol, stearic acid, magnesium stearate, and mannitol also did not affect the utility of this method.