阿莫西林克拉维酸钾缓释片含量测定及释放度测定方法研究

Study on Determination of Content and Release of Amoxicillin and Clavulanate Potassium Sustained-Release Tablets

目的建立了HPLC测定阿莫西林克拉维酸钾缓释片含量及释放度的检测方法。方法含量测定采用Hypersil ODS2 C185μm,4.6mm×200mm色谱柱;以磷酸盐缓冲液(取磷酸二氢钠7.8g,加水约900ml溶解,用磷酸或10mol/L氢氧化钠溶液调节pH值至4.4,加水稀释至1000ml)-甲醇(95:5)为流动相;检测波长为220nm。释放度测定以水1000ml为释放介质,桨法,转速75r/min,采用含量测定项下的色谱条件分别测定阿莫西林和克拉维酸的释放量。结果阿莫西林及克拉维酸浓度分别在0.1995～1.5042mg/ml(r=0.9993)和0.01243～0.09325mg/ml(r=0.9997)范围内与其峰面积呈良好的线性关系,阿莫西林及克拉维酸平均回收率(n=12)分别为99.2%和99.6%。结论本方法简便、准确,可用于阿莫西林克拉维酸钾缓释片的含量及释放度的测定。

Objective An HPLC method was established for the determination of content and release of Amoxicillin and Clavulanate Potassium Sustained-release Tablets.Methods The separation was performed on a Hypersil ODS2 C18 5 μm,4.6 mm×200 mm chromatography column.The mobile phase was composed of phosphate buffer （dissolve 7.8 g of monobasic potassium phosphate in 900 ml of water,adjust with phosphoric acid or 10 mol/L sodium hydroxide to a pH 4.4,then dilute with water to 1 000 ml,and mix ）-methanol （95：5）;Detection wavelength was 220 nm.For release determination,1 000 ml water was used as release medium,paddle method was used wiht rotation speed 75 r/min.Amoxicillin and clavulanate weere determined with the same chromatography condition.Results Both Amoxicillin and Clavulanate showed good linearity with peak area respectively in the range of 0.199 5～1.504 2 mg/ml（r=0.999 3） and 0.012 43～0.093 25 mg/ml（r=0.999 7）,respectively.The average recoveries （n=12） were 99.2% and 99.6%,respectively.Conclusion The method is simple,accurate and suitable for the determination of content and release of amoxicillin and clavulanate potassium sustained-release tablets.