盐酸二甲双胍缓释片的HPLC测定

Determination of Metformin Hydrochloride Sustained Release Tablets and Its Related Substances by RP-HPLC

建立了 RP- HPL C法测定盐酸二甲双胍缓释片的含量及有关物质。采用 ODS C1 8色谱柱 ,流动相为甲醇 -5 mm ol/ L磷酸二氢铵水溶液 (用磷酸调 p H至 3.5 ,含 0 .1% SDS) ( 6 5∶ 35 ) ,检测波长为 2 32 nm。线性范围 0 .0 0 5～1.0 mg/ ml,r=0 .9999;检测限 0 .1ng。平均回收率为 99.7% ,RSD为 0 .5 %。

A HPLC method for the determination of metformin hydrochloride sustained-release tablets and its related substances was presented. An ODS C 18 column was used, with mobile phase of methanol-5 mmol/L NH 4H 2PO 4 solution (65∶35, pH 3.5, adjusted with phosphoric acid, containing 0.1% SDS), at detection wavelength of 232nm. The linear range was 0.005～1.0 mg/ml, the detection limit was 0.1 ng, and the average recovery was 99.7% with RSD of 0.5%.