Thoppil S O, Amin P D
Department of Chemical Technology (Autonomous), Pharmaceutical Division, University of Mumbai, Nathalal Parikh Marg, Matunga, Mumbai 400 019, India.
J Pharm Biomed Anal. 2001 May;25(2):191-5. doi: 10.1016/s0731-7085(00)00483-0.
An accurate, specific and reproducible reversed phase liquid chromatographic method for the determination of trimetazidine hydrochloride in presence of its degradation products is reported. The mobile phase consisted of water-acetonitrile-triethylamine (90:10:0.1, v/v/v) adjusted with o-phosphoric acid to a pH of 3.3. Chromatography was performed using C-18 column at a flow rate of 1.0 ml/min and the drug along with its degraded products was detected at 270 nm. The calibration curve of trimetazidine hydrochloride in methanol was linear in the range 500-3000 ng. The mean value of correlation coefficient, slope and intercept were 0.99859 &# 0.001, 17.7986 &# 0.0709 and 482.56 &# 147.03, respectively. The limits of detection and quantitation were 5 and 20 ng, respectively. The recovery of trimetazidine hydrochloride was about 99-100%. This method was utilized to analyze trimetazidine hydrochloride from conventional tablets and controlled release pellets in the presence of commonly used excipients.
报道了一种准确、特异且可重现的反相液相色谱法，用于在其降解产物存在的情况下测定盐酸曲美他嗪。流动相由水 - 乙腈 - 三乙胺（90:10:0.1，v/v/v）组成，用磷酸调节至pH 3.3。使用C - 18柱进行色谱分析，流速为1.0 ml/min，在270 nm处检测药物及其降解产物。盐酸曲美他嗪在甲醇中的校准曲线在500 - 3000 ng范围内呈线性。相关系数、斜率和截距的平均值分别为0.99859±0.001、17.7986±0.0709和482.56±147.03。检测限和定量限分别为5和20 ng。盐酸曲美他嗪的回收率约为99 - 100%。该方法用于在常用辅料存在的情况下分析普通片剂和控释微丸中的盐酸曲美他嗪。
