反相高效液相色谱法同时测定肌酸,肌酸酐及肌酸乙酯盐酸盐

Simultaneous determination of creatine、 creatinine and creatine ethyl ester Hydrochloride by reversed-phase high performance liquid chromatography

建立了一种同时测定肌酸、肌酸酐和肌酸乙酯盐酸盐的反相高效液相色谱方法.采用Diamonsil^TM C18（250 mm×4.6 mm i.d.,5 μm）色谱柱,以V（乙腈）-V（0.2% H3PO4）-V（水）＝4∶6∶90为流动相,在波长为210 nm处进行检测,流速为1.0 mL/min.当肌酸、肌酸酐和肌酸乙酯盐酸盐的质量浓度范围分别为0.0003～0.0160,0.003～0.140,0.050～0.500 mg/mL时,峰面积与质量浓度呈良好的线性关系,相对标准偏差RSD分别为1.8%、1.3%和1.0%（n=5）,平均回收率分别为103.5%、101.4%和100.2%.该方法可用于肌酸乙酯盐酸盐的合成工艺研究及成品质量控制.

To develop a reversed-phase high performance liquid chromatography method for assaying creatine, creatinine, creatine ethyl ester hydrochloride; Creatine, creatinine and creatine ethyl ester hydrochloride were separated on Diamonsil^TM C- 18 column （250×4.6 mm ,5 μm） and detected at 210 nm by using acetonitrile-phosphoric acidwater （4：6：90, v/v/v） as mobile phase when the column temperature was 30 ℃ and the flow rate was 1.0 mL/min. The calibration curves of creatine, creatinine and creatine ethyl ester hydrochloride showed good linearities in the ranges of 0.0003 - 0.0160, 0.003 -0. 140, 0.050- 0. 500 mg/mL, respectively. The relative standard deviations （RSD） were 1.8%, 1.3% and 1.0% （n = 5） and the average recoveries were 103.5%, 101.4% and 100.2% respectively. The method can be applied to the synthetic process of ereatine ethyl ester hydrochloride and its quality control.