紫外光谱法同时测定大鼠血清中沙格列汀和达格列净含量的稳定性指示方法

Raveendra Bg, KumarRA, Shaheen Sd, A. Greeshma, M. Satyanarayana, Manikanta Rsht, Syam Cpb
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引用次数: 9

摘要

建立了用紫外光谱法同时测定大鼠血清中沙格列汀和达格列净的稳定性的新方法。沙格列汀检测波长为222 nm,以水为溶剂;达格列净检测波长为274 nm,以磷酸盐缓冲液pH 6.8为溶剂。两种药物的浓度范围为1 ~ 10 μg/mL。根据ICH指南对该方法进行了优化,并在加标大鼠血清中进行了验证。所有验证参数均在可接受范围内,在不同条件下进行的稳定性研究发现可忽略不计。该方法简便、灵敏;成功地应用紫外光谱法同时测定大鼠血清样品中沙格列汀和达格列净的含量。
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A Novel Stability-Indicating Method for the Simultaneous Estimation of Saxagliptin and Dapagliflozin in Rat Serum by Using UV Spectroscopy
A new approach developed for stability-indicating, simultaneous estimation of Saxagliptin and Dapagliflozin in rat serum by using UV spectroscopy. Saxagliptin detection wave length was at 222 nm with water is solvent and Dapagliflozin detection wave length was at 274 nm with phosphate buffer pH 6.8 is solvent. Both drugs are obeyed the beers-lamberts concentration range was founds to be 1-10 μg/mL. The present method was optimized and validated in spiked rat serum according to ICH guidelines. All validation parameters were found to be within the acceptable limits and stability-indicating studies were conducted under different conditions founds in negligible. The present method was simple and sensitive; it was successfully adopted for the simultaneous estimation of Saxagliptin and Dapagliflozin in rat serum samples by using UV spectroscopy.
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