稳定性指示高效薄层色谱法测定原料药和片剂剂型阿格列汀的含量

K. Patil, T. Deshmukh, V. Patil
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摘要

论文KR等人,稳定性指示高效薄层色谱法测定苯甲酸阿格列汀原料药和片剂剂型。美国医药技术研究杂志2019。稳定性指示高效薄层色谱法测定苯甲酸阿格列汀原料药和片剂剂型K R Patil*, T A Deshmukh, V R Patil 2 1。印度贾尔冈马穆拉巴德Arunamai药学院(MS) 2.Hon摘要苯甲酸阿格列汀是一种新型降糖药物,属于二肽基肽酶-4抑制剂类,可刺激葡萄糖依赖性胰岛素释放。建立了一种简便、准确、精密度高、稳定性好的高效液相色谱法测定苯甲酸阿格列汀片剂的含量。以三氯甲烷:甲醇3:7 v/v为流动相,在275 nm处进行紫外检测,实现了色谱分离。根据ICH指南对所开发的方法进行了线性、准确度、精密度、检出限、定量限和鲁棒性验证。药物经过酸水解、碱水解、光解、热降解等应激条件。结果表明,在500 ~ 2500 ng/波段浓度范围内呈线性关系。该方法可用于原料药和片剂剂型的定量分析
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Stability Indicating High Performance Thin Layer Chromatographic Determination of Alogliptin Benzoate as Bulk Drug and in Tablet Dosage Form
Please cite this article as: Patil KR et al., Stability Indicating High Performance Thin Layer Chromatographic Determination of Alogliptin Benzoate as Bulk Drug and in Tablet Dosage Form. American Journal of PharmTech Research 2019. Stability Indicating High Performance Thin Layer Chromatographic Determination of Alogliptin Benzoate as Bulk Drug and in Tablet Dosage Form K R Patil*, T A Deshmukh, V R Patil 2 1.SES Arunamai College of Pharmacy Mamurabad, Jalgaon (MS) 2.Hon. LMC College of Pharnmacy, Faizpur, Jalgaon (MS) ABSTRACT Alogliptin Benzoate is a novel hypoglycemic drug that belongs to dipeptidylpeptidase-4 inhibitor class which stimulates glucose dependent insulin release. The Present work describes development and validation of a new simple, accurate, precise and stability indicaing HPTLC method for the determination of alogliptin benzoate in tablet dosage form. The chromatographic separation was achieved by using Chloroform: Methanol 3:7 v/v as mobile phase and UV detection at 275 nm. The developed method was validated with respect to linearity, accuracy, precision, limit of detection, limit of quantitation and robustness as per ICH guidelines. The drug was subjected to stress condition of acid hydrolysis, alkali hydrolysis, photolysis, thermal degradation. Results found to be linear in concentration range of 500-2500 ng/band. The developed method can be used for the quantification of bulk drug as well as tablet dosage form
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