盐酸二甲双胍缓释片含量及有关物质的高效液相色谱法测定

摘要

Objective A HPLC method has been established for the determination of metformin hydrochloride and related substances. Methods The chromatographic system consists of waters μBondapak C18 10 μm 125 A (3. 9 mm ×300 mm)column,mobile phase:acetonitrile and pH 3. 85 buf er solution (0. 5 g/L of sodium heptanesulfonate and 0. 5 g/L of sodium chloride in water . soluble shake with 0. 35% phosphoric acid to a pH of 3. 85)(10∶90). with detection wavelength at 218 nm. The flow rate was 1. 0 ml/min. The column temperature was at 30 ℃. Re-sults The linearity was obtained in the rang of 20~200 μg/min of metformin hydrochloride ,Y=3082430X-16318 r=0. 99996. Conclusion The method was simple and accurate,the established method can be used for determination of metformin hydrochloride and related substances.%目的：用高效液相色谱法测定盐酸二甲双胍的含量及有关物质。方法选用Waters μBondapak C1810μm 125A （3．9 mm ×300 mm）色谱柱，流动相：以乙腈－pH 3．85缓冲液（取庚烷磺酸钠和氯化钠各0．5 g，加水约900 ml使溶解，摇匀，用0．35％磷酸溶液调节pH至3．85，加水至1000 ml）（10∶90），检测波长218 nm；流速1．0 ml／min；柱温为30℃。结果盐酸二甲双胍浓度在20～200μg／ml 与峰面积呈良好的线性关系，Y＝3082430X－16318（r＝0．99996）。平均回收率为100．2％，RSD＝0．82％（n＝5）。结论高效液相色谱法简便、准确，适用于盐酸二甲双胍含量及有关物质的测定。