HPLC法测定阿莫西林双氯西林钠胶囊含量

Analysis of amoxicillin and dicloxacillin by HPLC

目的建立阿莫西林双氯西林钠腔囊中阿莫西林和双氯西林钠的含量测定方法。方法采用Shimadzu VP-ODS色谱柱，流动相为0．008mol／L十二烷基硫酸钠（用磷酸调节至pH4．5）．甲醇（体积比68：32），检测波长225nm。结果阿莫西林和双氯西林在该色谱条件下均有合适的保留，测定可在10min内完成。阿莫西林在0．0050—1．0000mg／mL，双氯西林在0．0025～0．5036mg／mL质量浓度范围内与峰面积呈良好的线性关系。阿莫西林和双氯西林钠平均回收率（n=9）分别为99.4％（RSD=1．0％）和99．1％（RSD=0．97％）。结论该方法准确、重复性好、灵敏度高，可用于该产品的质量控制。

Objectlve To establish an HPLC method for simultaneously assaying of amoxicillin and dicloxacillin in capsules. Methods The separation was performed on a Shimadzu VP-ODS column. The mobile phase was 0.008 mol/L sodium lauryl sulpate （ adjusted with phosphoric acid to pH4. 5）- methanol （ 68 ： 32）. The detection wavelength was 230 nm. Results Amoxicillin and dicloxacillin had suitable retention time, which could be separated within 10 min. The standard curves of amoxicillin and dicloxacillin were all linear over the concentrations of 0.0050-1.0000 mg/mL （ r = 0. 9999, n = 7 ） and 0.0025 - 0.5036 mg/mL （ r = 0. 999 9, n=7 ）, respectively. The average recoveries of amoxicillin and diclxacillin were 99.4% （ RSD 1.0% ） and 99.1% （ RSD 0.97% ）, respectively. Conclusion This method is simple, sensitive, accurate and reproducible, which can be used for the quality of amoxicillin-dicloxacillin capsule.