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首页> 外文期刊>The Journal of automatic chemistry >Development and Validation of an HPLC Method for Determination of Antidiabetic Drug Alogliptin Benzoate in Bulk and Tablets
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Development and Validation of an HPLC Method for Determination of Antidiabetic Drug Alogliptin Benzoate in Bulk and Tablets

机译：HPLC法测定散装和片剂中抗糖尿病药物苯甲酸阿格列汀的开发与验证

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Alogliptin benzoate, a member of dipeptidyl peptidase-4 inhibitors, is a recent drug developed by Takeda Pharmaceutical Company for the treatment of Type 2 diabetes; it potentiates the effect of incretin hormones through the inhibition of their degradation. Alogliptin can be used alone or in combination therapy. A new sensitive and rapid HPLC method was developed for the determination of alogliptin benzoate in bulk and pharmaceutical dosage forms; it was validated according to ICH and FDA guidelines. The HPLC analysis was performed on the Agilent 1200 system equipped with a Hypersil Gold Thermo Scientific C18 (250?cm?×?4.6?mm) 5?μm column, with a mixture of acetonitrile and ammonium carbonate buffer in the ratio of 55?:?45 v/v as the mobile phase, at the flow rate of 1.0?mL/min. The detection was performed at the wavelength (λ) of 277, and the retention time of alogliptin benzoate was around 4?min. The total run time was 6.0?min. The calibration plot gave linear relationship over the concentration range of 85–306?μg/ml. The LOD and LOQ were 0.03 and 0.09?μg, respectively. The accuracy of the proposed method was determined by recovery studies and was found to be 100.3%. The repeatability testing for both standard and sample solutions showed that the method is precise within the acceptable limits. RSD% of the determination of precision was <2%. The results of robustness and solutions stability studies were within the acceptable limits as well. The proposed method showed excellent linearity, accuracy, precision, specificity, robustness, LOD, LOQ, and system suitability results within the acceptance criteria. In addition, the main features of the developed method are low run time and retention time around 4?min.
机译：二肽基肽酶-4抑制剂成员苯甲酸阿格列汀是武田制药公司开发的用于治疗2型糖尿病的最新药物;它通过抑制降解激素来增强肠降血糖素激素的作用。阿格列汀可单独使用或联合治疗。开发了一种灵敏，快速的HPLC新方法，用于测定散装和药物剂型中的阿格列汀苯甲酸酯。根据ICH和FDA指南进行了验证。 HPLC分析是在装有Hypersil Gold Thermo Scientific C18（250？cm？×？4.6？mm）5？μm色谱柱的Agilent 1200系统上进行的，其中乙腈和碳酸铵缓冲液的比例为55 ::流速为？45 v / v，流速为1.0？mL / min。该检测是在波长（λ）为277的条件下进行的，苯甲酸阿格列汀的保留时间约为4？min。总运行时间为6.0分钟。校准曲线在85–306？μg/ ml的浓度范围内给出线性关系。 LOD和LOQ分别为0.03和0.09？g。通过回收率研究确定了所提出方法的准确性，发现为100.3％。标准溶液和样品溶液的重复性测试表明，该方法在可接受的范围内是精确的。精密度测定的RSD％<2％。鲁棒性和解决方案稳定性研究的结果也在可接受的范围内。所提出的方法在可接受的标准内显示出优异的线性，准确性，精确度，特异性，鲁棒性，LOD，LOQ和系统适用性结果。此外，所开发方法的主要特点是运行时间短且保留时间约为4分钟。

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