本人现在用英国药典中规定的酸碱滴定的方法测定氨甲环酸注射液含量,结果总是偏低,且数据重现性不好。 ASSAY To a volume containing 0.1 g of Tranexamic Acid add 50 ml of water and adjust the solution to pH 7.0 with 0.1M sodium hydroxide or 0.1M hydrochloric acid . Add 25 ml of formaldehyde solution , previously adjusted to pH 7.0, and 20 ml of 0.1M sodium hydroxide VS and titrate with 0.1M hydrochloric acid VS determining the end point potentiometrically. Repeat the operation without the injection. The difference between the titrations represents the amount of sodium hydroxide required. Each ml of 0.1M sodium hydroxide VS is equivalent to 15.72 mg of C8H15NO2. 取本品适量(含氨甲环酸0.1g),加入50ml水,用浓度为0.1mol/L的氢氧化钠溶液或0.1mol/L的盐酸溶液调节pH至7.0.加入25ml甲醛溶液(pH调节至7.0),再加入20ml浓度为0.1mol/L的氢氧化钠溶液,用0.1mol/L的盐酸滴定液滴定至终点。空白溶液(不加氨甲环酸样品)相同操作。滴定差值即为所需氢氧化钠的量。每毫升0.1mol/l氢氧化钠滴定液相当于15.72mgC8H15NO2.