Objective: To improve the quality standard of compound acetylsalicylic acid tablets and improve its quality control level. Methods: The proposed quality control items of compound acetylsalicylic acid tablets were determined according to the ChP（2015 edition, volume 4）. The TLC identification method were established. The HPLC method for HPLC identification（1）, free salicylic acid, dissolution, content uniformity and content determination were established at the same time. The tablets dissolution method were established with three principal components in compound acetylsalicylic acid tablets. Results: The methods of HPLC identification（1） and TLC identification（2）were specific, simple and rapid. The HPLC methods for determination of free salicylic acid, dissolution, content uniformity and content determination were established, their linearity and repeatability were good. The recovery results were conformed to the requirements. The ranges for the free salicylic acid contents and content uniformity（caffeine）of 9 batches were 0. 1%-0. 3% and 98. 0%-102. 9%. The ranges for the content determination of acetyl salicylic acid, phenacetin and caffeine were 97. 9%-101. 7%, 98. 1%-103. 9% and 96. 8%-103. 1% respectively. The dissolution of aspirin phenacetin and caffeine（APC）were mostly between 79%-101%. Dissolution results from some companies were failed. The limit of each test items for compound acetylsalicylic acid tablets were proposed as follows: limit of free salicylic acid was 0. 3%, the dissolution limit of APC was 75%. Conclusion: The established method improves the quality control of compound acetylsalicylic acid tablets.
CHEN Cheng-gui, LIU Min, LI Mei-fang, PANG Fa-gen, LI Yu-lan, WANG Tie-jie
. Study on the quality standard of compound acetylsalicylic acid tablets*[J]. Chinese Journal of Pharmaceutical Analysis, 2021
, 41(3)
: 515
-524
.
DOI: 10.16155/j.0254-1793.2021.03.18
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