HPLC法测定不同溶出介质中的阿莫西林胶囊溶出曲线

Determination of the Dissolution Curve of Amoxicillin Capsule in Different Dissolution Medium by HPLC

目的:建立测定阿莫西林胶囊在不同溶出介质中溶出曲线的方法。方法:采用HPLC法,色谱柱为InertsilODS-SP,5μm,4.6*250mm;流动相0.1361%醋酸钠溶液(用醋酸调节pH为4.5)-甲醇(947:53);检测波长:230nm。溶出介质分别为pH1.2、pH4.0、pH6.8、水,转速100rpm,37℃。当溶出介质为pH1.2时,在取样管中预加醋酸钠溶液对溶出液进行中和。对阿莫西林胶囊溶出液进行测定并计算累计溶出度,绘制溶出曲线。结果:阿莫西林浓度在24.71-370.6μg/mL范围内有良好的线性关系(R^2=0.9998),各溶出介质中的回收率在100.02%-100.41%,RSD均<1%。结论:该方法简便可行,解决了阿莫西林在酸性条件下检测不稳定的问题,可用于阿莫西林胶囊在不同溶出介质中溶出曲线的测定。

Objective:To develop a method for determination the dissolution curve of Amoxicillin capsule in different medi- um. Method:The HPLC separation was performed on a Inertsil ODS-SP(5μm,4.6*250mm)column. The mobile phase was 0.1361% NaAC buffer(adjust to pH4.5 by HAC)- methanol(947:53);the detection wavelength was 230nm. Four dissolution media including pH 1.2 hydrochloric acid solution,pH 4.0 buffer solution,pH 6.8 buffer solution and water were used,the rotating speed was 100rpm ,the water bath temperature was 37℃. The cumulative dissolution curve was ploted by determinating the cumulative dissolution percentage. Results:The linear range was 24.71~ 370.6μg/mL(R^2=0.9998),the recovery in different medium was 100.02%-100.41%,RSD was less than 1%. Conclusion:The method was simple and viable,which can be applied to solve the stability in the determination of Amoxicillin capsule in different medium.