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本文采用HPLC法测定了吲嗪美辛控释栓的含量并研究了该栓剂的稳定性。建立的分析条件是,流动相为甲醇—0.05%醋酸溶液(45∶55,V/V),色谱柱Zorbax-CX(250×4.6mm id),检测波长UV254 nm,以四氢呋喃和甲醇为溶剂系统提取栓剂中的吲哚美辛,内标物为间二硝基苯,进样量4μl,实验样品的平均回收率为96.76%,变异系数0.81%。经两点法恒温加速试验结果表明,吲嗪美辛在栓剂中的降解为一级动力学过程,反应活化能E_a=18.64千卡/克分子·度,在25℃的贮存期t_(0.8)=16.4(月)。
In this paper, HPLC determination of indometacin controlled release suppository content and study the stability of the suppository. The analytical conditions were as follows: methanol-0.05% acetic acid solution (45:55, V / V), Zorbax-CX (250 × 4.6 mm id), detection wavelength UV254 nm and tetrahydrofuran and methanol as solvent The suppository was extracted indomethacin, the internal standard was m-dinitrobenzene, injection volume 4μl, the average recovery rate of the experimental samples was 96.76%, the coefficient of variation of 0.81%. The results of two-point thermostatic accelerated test showed that the degradation of indomethacin in the suppository was a first-order kinetic process, the activation energy E_a = 18.64 kcal / mol · mol-1, storage time at 25 ℃ was (t 0.8) = 16.4 (month).