Wang D P, Chang L C, Wang M T
School of Pharmacy, National Defense Medical Center, Neihu, Taiwan, Republic of China.
Drug Dev Ind Pharm. 2001 Oct;27(9):997-1001. doi: 10.1081/ddc-100107682.
A stability-indicating reversed-phase performance liquid chromatographic method was developed for the detection of 4-(N,N-dimethylamino)phenol (4-DMAP) and its degradation products under accelerated degradation conditions. The degradation kinetics of 4-DMAP in aqueous solution over a pH range of 1.12-6.05 and its stability in solutions based on propylene glycol or polyethylene glycol 400 were investigated. The observed rate constants were shown to follow, apparent first-order kinetics in all cases. The pH rate profile shows that maximum stability of 4-DMAP was observed in the pH range 2.0 to 3.0. Acid/base catalysis of 4-DMAP was not affected by systems of various ionic strengths. Incorporation of nonaqueous propylene glycol or polyethylene glycol 400 in the pH 3.05 solution of 4-DMAP showed an increase in the stability at 55 degrees C +/- 0.5 degrees C.
建立了一种稳定性指示反相高效液相色谱法，用于检测加速降解条件下的4-(N,N-二甲基氨基)苯酚(4-DMAP)及其降解产物。研究了4-DMAP在pH值为1.12-6.05的水溶液中的降解动力学及其在基于丙二醇或聚乙二醇400的溶液中的稳定性。在所有情况下，观察到的速率常数均符合表观一级动力学。pH速率曲线表明，在pH值2.0至3.0范围内观察到4-DMAP的最大稳定性。4-DMAP的酸碱催化不受各种离子强度体系的影响。在4-DMAP的pH 3.05溶液中加入非水丙二醇或聚乙二醇400，在55℃±0.5℃下稳定性增加。
