HPLC法测定复方氨苄西林/丙磺舒胶囊溶出度

Dissolution test of compound ampicillin and probenecid capsules by HPLC

建立准确、快速的溶出度测定方法,为制定药品质量标准提供依据。以pH6.8磷酸盐缓冲溶液250ml为溶剂,转速100r/min,30min取样,采用高效液相色谱法同时测定氨苄西林和丙磺舒的溶出量。色谱柱:HypersilODS(5μm,4.6mm×150mm),流动相:乙腈—离子对缓冲液(磷酸二氢钠6.00g,十二烷基硫酸钠5.78g,冰乙酸10ml,加水至1000ml,磷酸调pH2.5)(45∶55,v/v),检测波长230nm,流速:1.0ml/min,氨苄西林和丙磺舒的线性范围分别为116～350μg/ml(r=0.9999)和33～100μg/ml(r=0.998),平均回收率分别为99.8%和101.2%(n=6),考察3批样品的溶出度,结果均大于90%。方法简便、准确、重现性好。

To establish an accurate and rapid method for the dissoulotion determination of compound ampicillin and probenecid capsules,provide basis for the quality control of this preparation.Phosphate buffer (pH6.8) was used as the solvent,and the paddle rotated at 100r/min,The content of ampicillin and probenecid was determined simultaneously by HPLC.Hypersil ODS column (5μ m,4.6mm× 150mm) was used,and the mobile phase was acetonitrile— ion pair buffer solution (consisting of 6.00g sodium dihydrogen phosphate,5.78g SDS and 10ml glacial acetic acid,addition of water to 1000ml,adjusted to pH2.5 with phosphate acid)(45∶ 55),The flow rate was 1.0ml/min with detection wavelength at 230nm.The linear ranges were from 116～ 350μ g/ml for ampicillin(r=0.9999) and 33～ 100μ g/ml for pronbenecid (r=0.9998).The average recovery rates were 99.8% and 101.2% with RSD 0.84% and 0.72% for ampicillin and probenecid respectively (n=6).The dissolved amount of three batch samples were more than 90% .The method was simple,reproductible and accurate.