Aboul-Enein H Y, Abu-Zaid S
Pharmaceutical Analysis Laboratory, Biological and Medical Research Department, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi-Arabia.
Pharmazie. 2001 Aug;56(8):626-8.
A validated analytical method of S-adenosyl-L-methionine (SAM) in pharmaceutical preparations by reversed phase high performance liquid chromatography (RP-HPLC) is described. The compound is separated by a 2.1 mm x 15 cm, 5 microns--Discovery C18 column with isocratic elution. The effect of different anionic surface active agents with different molarity on the separation was studied. A direct relationship between the molarity of the surface active agents and the capacity factor (k') was found. The limit of detection was 0.49 mmol/ml and the linearity was r = 0.999 in the concentration range 20-100 micrograms/ml. Inter- and intra-assay variation was determined for three selected concentrations (20, 60, 100 micrograms/ml) by calculating the analytical recoveries with a range of 97.0-99.9%. The procedure was also suitable to check the stability of S-adenosyl-L-methionine in solution at room temperature.
本文描述了一种通过反相高效液相色谱法（RP-HPLC）测定药物制剂中S-腺苷-L-甲硫氨酸（SAM）的经过验证的分析方法。该化合物通过一根2.1毫米×15厘米、5微米的Discovery C18柱以等度洗脱进行分离。研究了不同摩尔浓度的不同阴离子表面活性剂对分离效果的影响。发现表面活性剂的摩尔浓度与容量因子（k'）之间存在直接关系。检测限为0.49毫摩尔/毫升，在20-100微克/毫升的浓度范围内线性关系为r = 0.999。通过计算97.0-99.9%范围内的分析回收率，测定了三个选定浓度（20、60、100微克/毫升）的批间和批内变异。该方法也适用于检测S-腺苷-L-甲硫氨酸在室温下溶液中的稳定性。
