紫外分光光度法同时测定阿莫西林和氟氯西林的含量。

M. Eissa
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引用次数: 5

摘要

采用分光光度法同时测定阿莫西林(AMX)和氟氯西林(FLX)的纯剂型和胶囊制剂的含量。第一种方法是比值差法(ratio difference, RD),测定AMX在238 ~ 255 nm之间和FLX在254 ~ 238 nm之间的振幅差。二是比值光谱平均定心(MCR),测定了测定AMX的286nm处的峰幅和测定FLX的236 nm处的峰幅。第三种方法为曲线下面积法(Area under The curve, AUC),其中AMX测定范围为226 nm和236 nm, FLX测定范围为240 nm和247 nm。上述方法均可用于定量AMX和FLX的浓度范围(分别为5 ~ 50µg/ml和10 ~ 70µg/ml),以及AUC法测定AMX和FLX的浓度范围(分别为10 ~ 60µg/ml和10 ~ 70µg/ml)。所有开发的方法都使用ICH指南进行验证,并与已报道的方法进行统计比较。所采用的方法可用于QC实验室AMX和FLX混合物的常规分析。
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UV SPECTROPHOTOMETRIC METHODS FOR THE SIMULTANEOUS DETERMINATION OF AMOXICILLIN AND FLUCLOXACILLIN.
Spectrophotometric methods were introduced for the simultaneous determination of Amoxicillin (AMX) and flucloxacillin(FLX) in their pure forms and  capsules pharmaceutical formulations. The first method was ratio difference (RD), in which the amplitude difference between 238 and 255 nm for AMX and between 254 and 238 nm for FLX were measured.The second one was mean centering of ratio spectra (MCR) in which the peak amplitude at 286nm for the determination of AMX and the peak amplitude at 236 nm for the estimation of FLX were measured. The third method was Area under the curve (AUC) where the range of 226 and 236 nm were adopted for AMX determination and of 240 and 247 nm for FLX determination. All of the previous methods were successfully used for quantitation of AMX and FLX in concentration ranges of 5-50µg/ml and 10-70µg/ml, respectively by RD and MCR methods and of 10-60µg/ml and 10-70µg/ml, respectively for AMX and FLX by AUC method. All of the developed methods were validated using ICH guidelines and statistically compared to a reported method. The adopted methods can be applied for the regular analysis of AMX and FLX mixture in QC laboratories.
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