【含量测定】照高效液相色谱法（通则0512）测定。 色谱条件与系统适用性试验用十八烷基硅烷键合硅胶 为填充剂，以乙腈-四氢呋喃-冰醋酸-水(20：5：5：70)为流 动相；检测波长为276nm。理论板数按阿司匹林峰计算不低 于3000，阿司匹林峰与水杨酸峰的分离度应符合要求。 测定法取本品20片，精密称定，充分研细，精密称取细 粉适量（约相当于阿司匹林10mg),置100ml量瓶中，用1%冰 醋酸的甲醇溶液强烈振摇使阿司匹林溶解，并用1%冰醋酸 的甲醇溶液稀释至刻度，摇匀，滤膜滤过，取续滤液作为供试 品溶液，精密量取10l注人液相色谱仪，记录色谱图；另取阿 司匹林对照品，精密称定，珈1%冰醋酸的甲醇溶液振摇使溶 解并定量稀释制成每1ml中约含0.1mg的溶液，同法测定。 按外标法以峰面积计算，即得
Aspirin Tablets General Notices 英国药典(2018) Acetylsalicylic Acid Tablets Action and use Salicylate;non-selective cyclo-oxygenase inhibitor;antipyretic;analgesic;anti-inflammatory DEFINITION Aspirin Tablets contain Aspirin. gomply with the requirements stated under Tablets and with the foliowina Content of aspirin,CaHaO4 95.0 to 105.0%of the stated amount. IDENTIFICATION Boil 0.5 g of the powdered tablets for 2 to 3 minutes with 10 mL of 5M sodiwm hydroxide,cool and add an excess of 1M su/furic acid;a crystalline precipitate is produced.To a solution of the precipitate in water add iron(//l)chloride solution R1:a deep violet colour is produced. TESTS Salicylic acid containing 0.20 a temperatu transfe ssler cylinder of freshly prepared ammonium 80,8ae”2 wow tand o5028C8882 allow to stand for 1 minute.Any violet colour produced is su/fate solution R1 to a mixture of 3 mL of a freshly prepared 0.10%w/v solution of salicylic acid,2 mL of ethano/(96%)and sufficient water to produce 50 mL contained in a second Nessler cylinder (3.0%). Dissolution Comply with the requirements for Monographs of the British Pharmacopoeia in the disso/ution test for tablets and capsules,Appendix XII B1. TEST CONDITIONS (a)Use Apparatus 1,rotating the basket at 50 revolutions per minute. the medium. PROCEDURE
英国药典（2018）
(1)After 45 minutes withdraw a sample of the medium and measure the absorbance of the filtered sample,suitably diluted with the dissolution medium if necessary,at the maximum at 265 nm,Appendix ll B using dissolution medium in the reference cell. (2)Measure the absorbance of a suitable solution of aspirin BPCRS using dissolution medium in the reference cell. DETERMINATION OF CONTENT Calculate the total content of aspirin,CoHaO4,in the medium from the absorbances obtained and using the declared content of CaHaO4 in aspirin BPCRS ASSAY Weigh and powder 20 tablets.To a quantity of the powder containing 0.5 g of Aspirin add 30 mL of 0.5M sodium hydroxide VS,boil gently for 10 minutes and titrate the excess of alkali with 0.5M hydrochloric acid VS using phenol red solution as indicator.Repeat the operation without the substance being examined.The difference between the titrations represents the amount of sodium hydroxide required.Each mL of 0.5M sodium hydroxide VS is equivalent to 45.04 mg of CaHaO4. LABELLING The label states that the tablets contain Aspirin,unless this word appears in the name of the tablets.This requirement does not apply in countries where exclusive proprietary rights in the name Aspirin are claimed
USP41-NF36 Aspirin Tablets >Aspirin Tablets contain not less than 90.0 per- cent and not more than 110.0 percent of the la- beled amount of aspirin (CoH8O4).Tablets of larger than 81-mg size contain no sweeteners or other flavors. NOTE-Tablets that are enteric-coated meet the requirements for Aspirin Delayed-Release Tablets. Packaging and storage-Preserve in tight containers.Pre- serve flavored or sweetened Tablets of 81-mg size or smaller in containers holding not more than 36 Tablets each. USP Reference standards (11) USP Aspirin RS USP Salicylic Acid RS Identification- A:Crush 1 Tablet,boil it with 50 mL of water for 5 min- utes,cool,and add 1 or 2 drops of ferric chloride TS:a violet-red color is produced. B:Infrared Absorption (197K)-Prepare the test specimen as follows.Shake a quantity of finely powdered Tablets, equivalent to about 500 mg of aspirin,with 10 mL of alco- hol for several minutes.Centrifuge the mixture.Pour off the clear supernatant,and evaporate it to dryness.Dry the resi- due in vacuum at 60 for 1 hour
USP41-NF36