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建立高效液相色谱法测定依托度酸缓释片含量的方法,并测定自制样品的含量稳定性。使用色谱柱C18(4.6 mm×250 mm,5μm);乙腈-pH4.75磷酸盐缓冲液(45∶55)为流动相,对依托度酸缓释片含量分析方法进行验证,并测定自制制剂的含量稳定性。依托度酸在2.02~14.11μg/mL范围内浓度与峰面积线性关系良好,方法精密度,耐用性合格,平均回收率为99.87%,RSD=0.25%,自制片含量稳定性较好。该方法简便、准确,可用于依托度酸缓释片含量和稳定性测定。
A method for the determination of etanercept sustained release tablets by HPLC was established and the content stability of homemade samples was determined. The column C18 (4.6 mm × 250 mm, 5 μm) and acetonitrile-pH 4.75 phosphate buffer (45:55) were used as the mobile phase to determine the content of etodolac sustained-release tablets. Content stability. The linearity of concentration and peak area of etodolac in the range of 2.02-14.11μg / mL was good. The precision and durability of the method were satisfactory. The average recovery was 99.87% and the RSD was 0.25%. The method is simple and accurate and can be used for the determination of the content and stability of sustained-release tablets.