Simultaneous determination of anti-diabetic drugs

A novel reverse phase, isocratic HPLC method is described to separate five anti-diabetic drugs i.e., glimepiride, metformin, sitagliptin, rosiglitazone and pioglitazone. Nucleosil C18 analytical column was used as stationary phase, while mobile phase consisted of acetonitrile:phosphate buffer: methanol (40/40/20, v/v) pH 2.0. Effluent was monitored at a flow rate 1 mL/min and detected at wavelength of 240 nm. This research produced excellent chromatography over a wide concentration range of 25-10000 ng/mL. Sepprated and well resolved quantifiable peaks were obtained and test results were linear in this range. Correlation coefficient of more than 0.9990 was witnessed as well as Low %RSD values i.e., maximum 2.0% documented excellent precision of the method. Good recoveries from pharmaecutical (99-101%), urine and plasma samples (>96%) in a range of concentrtion granted very good linearity, accuracy and precision. The projected method has satisfactory applications in quality control of these molecules as well as quantification of these molecules in urine and plasma samples.

本文报道了一种新型反相等度高效液相色谱（reverse phase isocratic HPLC）方法，用于分离五种抗糖尿病药物，即格列美脲、二甲双胍、西格列汀、罗格列酮与吡格列酮。色谱柱采用Nucleosil C18分析柱作为固定相，流动相由乙腈、磷酸盐缓冲液与甲醇按体积比40:40:20（v/v）混合而成，pH值调节至2.0。该方法以1 mL/min的流速洗脱，检测波长设定为240 nm。本方法在25~10000 ng/mL的宽浓度范围内展现出优异的色谱性能，可获得分离度良好、可准确定量的色谱峰，且该浓度范围内的检测结果呈良好线性关系。方法的相关系数均大于0.9990，相对标准偏差（Relative Standard Deviation，%RSD）最大值仅为2.0%，充分证明该方法具备极佳的精密度。对药物制剂、尿液及血浆样品开展不同浓度的加标回收实验，结果显示回收率分别可达99%~101%与96%以上，进一步验证了该方法优异的线性度、准确度与精密度。所建立的方法可令人满意地应用于上述抗糖尿病药物的质量控制，以及尿液与血浆样品中该类药物的定量检测。