Thomis R, Roets E, Hoogmartens J
J Pharm Sci. 1984 Dec;73(12):1830-3. doi: 10.1002/jps.2600731246.
The high-performance liquid chromatographic method described enables the quantitation of the components and the main impurities of tablets containing aspirin, acetaminophen, and ascorbic acid. A C8 reverse-phase column was used; the mobile phase was methanol-0.2 M phosphate buffer (pH 3.5)-water (20:10:70). Results obtained for a brand of effervescent tablets, normally aged for 5 years and stressed at 37 degrees C, 50 degrees C, or in 79% relative humidity at room temperature, are reported. Salicylic acid was the main product of decomposition. Diacetyl-p-aminophenol was observed to be formed by transacetylation.
所描述的高效液相色谱法能够对含有阿司匹林、对乙酰氨基酚和抗坏血酸的片剂中的成分及主要杂质进行定量分析。使用了C8反相柱;流动相为甲醇 - 0.2 M磷酸盐缓冲液(pH 3.5)- 水(20:10:70)。报告了一种泡腾片在正常老化5年以及在37℃、50℃或室温下79%相对湿度条件下加速试验后的结果。水杨酸是主要的分解产物。观察到二乙酰对氨基酚是通过转乙酰化形成的。