HPLC法测定盐酸二甲双胍缓释片的含量  

Determination of Metformin Hydrochloride Sustained-release Tablets by HPLC

作　　者：陈秀琳[1] 

机构地区：[1]福建省药品检验所,福州350001

出　　处：《海峡药学》2013年第12期108-109,共2页Strait Pharmaceutical Journal

摘　　要：目的 建立盐酸二甲双胍缓释片[1]含量测定的方法.方法 色谱柱为Welch Materials C18柱（4.6mm×250mm,5μm）,流动相为含0.1%庚烷磺酸钠和0.4%三乙胺的0.1mol·L-1 磷酸二氢钾缓冲溶液（用磷酸调pH至3.6）-甲醇（85：15）;流速：1.0mL·min-1;检测波长为233nm.结果 在4.104μg·mL-1～41.04μg·mL-1浓度范围内与峰面积呈良好的线性关系,平均回收率为99.3%,RSD为1.2%（n=9）.结论 该方法操作简便、准确可靠.OBJECTIVE To establish the HPLC method for the determination of metformin hydrochloride sustained-release tablets. METHODS The analytical column was Welch Materials C ls column （4.6mm × 250mm, 5μm） and the mobile phase containing 0. 1% sodium heptane and 0. 4% triethylamine 0. 1mol · L-1 phosphate potassium hydroxide buffer solution （ adjusted with phosphoric acid to pH 3.6 ） -methanol （ 85 ： 15 ）, at a flow rate of 1.0mL · min-1. The UV detection wavelength was at 233nm. RESULTS The linearity was good for metformin hydrochloride within the range of 4. 104μg · mL-1 -41. 04μg · mL-1 ,the mean recovery was 99. 3% （n =9） ,RSD = 1.2% ;CONCLUSION The method is simple,accurate and precise.

关 键 词：盐酸二甲双胍缓释片 含量测定 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]