论文部分内容阅读
目的:建立高效液相色谱法同时测定复方盐酸二甲双胍/沙格列汀渗透泵控释片的含量。方法:采用Ultimate~XBCN色谱柱(250 mm×4.6 mm,5μm),流动相为0.01 mol·L~(~(-1))磷酸二氢钾溶液(p H=4.7)-乙腈(15∶85),检测波长为208nm,流速为1.0 ml·min~(-1),柱温为30℃,进样量20μl。结果:盐酸二甲双胍和沙格列汀分别在50.0~150.0μg·ml~(-1)和0.5~1.5μg·ml-~(-1)浓度范围内与峰面积线性关系良好(r=0.999 9和r=0.999 1)。平均回收率分别为99.5%和100.3%,RSD分别为0.56%和1.20%(n=9)。结论:该法专属性强,结果准确可靠,可用于复方盐酸二甲双胍/沙格列汀渗透控释片的质量控制。
Objective: To establish a HPLC simultaneous determination of compound metformin hydrochloride / sitagliptin osmotic pump controlled release tablets. Methods: The mobile phase consisted of Ultimate ~ XBCN column (250 mm × 4.6 mm, 5 μm) with 0.01 mol·L ~ (-1) potassium dihydrogen phosphate solution (p H = 4.7) 85). The detection wavelength was 208nm, the flow rate was 1.0 ml · min ~ (-1), the column temperature was 30 ℃ and the injection volume was 20μl. RESULTS: Metformin hydrochloride and saxagliptin had a good linear relationship with the peak area in the range of 50.0-150.0 μg · ml -1 and 0.5-1.5 μg · ml -1, respectively (r = 0.999 9 and r = 0.999 1). The average recoveries were 99.5% and 100.3%, respectively, with RSDs of 0.56% and 1.20%, respectively (n = 9). Conclusion: The method is highly specific and accurate and reliable. It can be used for the quality control of compound metformin hydrochloride / sitagliptin hydrochloride controlled release tablets.