RP-HPLC法测定甲磺酸卡莫他特的含量及有关物质  

RP-HPLC determination of camostat mesilate and its related substances

作　　者：胡连栋[1] 罗兆亮[1] 刘慈[1] 邢倩斌[1] 娄焕军 

机构地区：[1]河北大学药学院,保定071002 [2]山东恒瑞医药科技发展有限公司,济南250000

出　　处：《药物分析杂志》2009年第9期1507-1509,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立HPLC法测定甲磺酸卡莫他特原料药的含量及其有关物质。方法:采用VenusilX BP-C18柱(250mm×4.6mm,5μm),以甲醇-0.01mol·L-1四丁基氢氧化铵溶液(25∶75,用磷酸调节pH至3.5)为流动相,流速1.0mL·min-1,紫外检测波长265nm,室温,进样量20μL。结果:主峰能与相邻杂质峰较好分离。甲磺酸卡莫他特浓度在5.0～81.3μg·mL-1范围内,与峰面积呈线性关系,r=0.9996。低、中、高浓度平均加样回收率(n=3)分别为99.7%,99.2%,100.1%;RSD分别为0.65%,0.51%,0.47%。结论:本法准确、方便,专属性强,可用于测定甲磺酸卡莫他特原料药含量及有关物质。Objective：To establish an HPLC method to determine the content of camostat mesilate and its related substances. Methods： The assay was conducted on a Venusil XBP - C ms column （ 250 mm × 4.6 mm, 5 μm） with methanol - 0.01 mol · L- 1 tetrabutylammonium hydroxide （25： 75, adjusted to pH 3.5 with phosphoric acid） as mobile phase at the flow rate of 1.0 mL · min- 1 and the detection wavelength was set at 265 am. Results： Camostat mesilate was completely separated from impurities. The linear concentration range of calnostat mesilate was 5.0 - 81.3 μg · mL-1 with the correlation coefficient of 0. 9996. The recoveries（n = 3） of low, medium and high concen- tration were 99.7% ,99.2%, 100. 1%, and RSDs were 0.65% ,0.51% ,0. 47% respectively. Conclusion： This accurate and reliable HPLC method is applicable for the quality control of camostat mesilate and its related sub- stances.

关 键 词：高效液相色谱法 甲磺酸卡莫他特 含量测定 有关物质 

分 类 号：R917[医药卫生—药物分析学]