RP-HPLC法测定阿莫西林克拉维酸钾干混悬剂(14:1)中阿莫西林、克拉维酸的含量  

Determination of amoxicillin and clavulanate potassium suspension(14:1) by RP-HPLC

作　　者：张亚洲[1] 樊兰兰[1] 屈啸声[1] 冯洁[2] 魏涌标[2] 

机构地区：[1]广西药用植物园,广西南宁530023 [2]广西医科大学,广西南宁530021

出　　处：《安徽医药》2013年第2期207-210,共4页Anhui Medical and Pharmaceutical Journal

摘　　要：目的建立高效液相色谱法同时测定阿莫西林克拉维酸钾干混悬剂(14∶1)中阿莫西林和克拉维酸钾的含量。方法采用依利特C18色谱柱(4.6 mm×150 mm,5μm),岛津L—10A高效液相色谱仪,用十八烷基硅烷键合硅胶为填充剂;以磷酸盐缓冲液(取磷酸二氢钠7.8 g,加水900 mL溶解,用磷酸或10 mol.L-1氢氧化钠溶液调节pH值至4.4±0.1,加水稀释至1 000mL)-甲醇(95∶5)为流动相;流速:1.0 mL.min-1;检测波长为220 nm。结果阿莫西林在0.332 1～1.162 3 g.L-1的浓度范围内,相关系数为0.999 6,平均回收率(n=9)为99.45%,RSD为0.34%。克拉维酸在0.028 1～0.098 4 g.L-1的浓度范围内,相关系数为0.999 8,平均回收率(n=9)为100.47%,RSD为0.99%。两者的浓度和峰面积之间线性关系良好。阿莫西林(C16H19N3O5S)(以无水物计)为标示量的90.0%～110.0%,克拉维酸(C8H9NO5)(以克拉维酸计)为标示量的90.0%～120.0%。结论该测定方法简便、准确、可靠,灵敏度高,可作为阿莫西林克拉维酸钾干混悬剂(14∶1)中阿莫西林、克拉维酸钾的质量控制方法。Objective To establish an HPLC method for simultaneous determination of the content of Amoxicillin and Clavulanate Potas- sium Suspension（ 14：1 ）. Methods YILITE C ls column （4.6 mm ×15mm,5μm） and Shimadzu LC-10A high performance liquid chromatography were adopted using octadecylsilane bonded silica as a filler;phosphate buffer （ Nail2 PO4 7.8 g added with water 900 mL, pH value adjusted to 4.4 - 0.1 with phosphate or 10 mol L-1 NaOH solution before diluted with water to 1 000 mL） -methanol（95： 5） as the mobile phase. The flow rate was set at 1.0 mL min-1 and detection wavelength was 220 nm. Results Amoxicillin was lineat in the range of 0.332 1- 1. 162 3 g L-1 with a correlation coefficient 0.999 6, average recoveries（n = 9）99.45% and RSD 0.34%. Clavulanic acid was liaear in the range of 0.028 1 - 0.098 4 g L - 1 with a the correlation coefficient 0.999 8, average recoveries（ n = 9） 100.47%, and RSD 0.99%. There was a good linear relationship between concentration and peak area. Conclusion The method is simple, accurate, reliable, and highly sensible, which can be used as a quality control method for Amoxicillin and Clavulanate Potassium （ 14 ： 1 ） suspension.

关 键 词：阿莫西林 克拉维酸钾 HPLC 含量测定 

分 类 号：R927.2[医药卫生—药学]