高效液相色谱法测定氨苄西林/丙磺舒胶囊中氨苄西林、丙磺舒的含量

Content Determination of Ampicillin and Probenecid in Ampicillin/Probenecid Capsules by HPLC

目的:建立测定氨苄西林/丙磺舒胶囊中氨苄西林、丙磺舒含量的高效液相色谱法(HPLC法)。方法:采用Waters2690-2487型高效液相色谱仪,SymmetryShieldTMRP18柱(150mm×3.9mm,5μm)。氨苄西林流动相为0.068mol/L的磷酸二氢钾溶液(pH=3.0)-乙腈(92∶8,V/V);丙磺舒流动相为水-乙腈-1mol/L磷酸二氢钾溶液-1mol/L冰醋酸(59.5∶39.8∶0.62∶0.08,V/V),加入0.15%的三乙胺调节pH=2.76;流速均为1.4mL/min。氨苄西林检测波长为210nm,丙磺舒检测波长为254nm。结果:氨苄西林的浓度线性范围为1.25～40μg/mL(r=0.9999),丙磺舒的浓度线性范围为0.308～10μg/mL(r=0.9999)。结论:HPLC法操作简便、灵敏、快速、重现性好,适用于该产品中氨苄西林、丙磺舒含量的测定。

Objective： To develop HPLC method for determination of ampicillin and probenecid content in ampicillin/probenecid capsules. Methods： A Symmetry Shield^TM RP18 column（150 mm×3.9mm,5μm） was used. The mobile phases for ampicillin was 0.068 mol/L KH2PO4 （pH =3.0）-acetonitre （92：8, V/ V）; the mobile phases for probenecid was H2O-acetonitrile-1 mol/L KH2PO4-1 mol/L acetic acid （59.5 ： 39.8 ： 0.62 ： 0.08, V/V）, and added 0. 15% triethylamine （pH = 2. 76）. The detective wavelength was 210 nm for ampicillin and 254 nm for probenecid. Results： The calibration curve of ampicillin was linear in the range of 1.25 -40μg/mL（r=0. 999 9）.The calibration curve of probenecid was linear in the range of 0. 308 - 10μg/mL（r=0. 999 9）. Conclusion： The analysis method was simple, sensitive and rapid. It can be used to determine the ampicillin and probenecid content in ampicillin/probenecid capsules.