根据指南,开发并验证了一种灵敏、准确、经济的平面色谱法,用于Desidustat的定量

IF 1.3 Q4 CHEMISTRY, ANALYTICAL
Rutvik H Pandya, Hetaben M. Kachhiya, Dhavalsinh P. Solanki, Jinal N. Tandel, U. Chhalotiya, D. Shah
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引用次数: 0

摘要

治疗慢性肾脏疾病贫血的新希望是最近批准的Desidustat。根据国际协调会议质量指南Q2 (R1),开发了一种经济高效的薄层色谱法来估计灭司他的含量。固定相为预包被硅胶60f254板,流动相为甲苯:甲醇:冰醋酸(7.5:2.5:0.3 v/v/v),最佳检测波长为230 nm。该方法在100 ~ 600 ng/波段范围内呈线性关系,回归系数为0.9979。标准加样方法准确度为99.21% ~ 101.63%。检测限为3.94 ng/波段,定量限为11.94 ng/波段。结果表明,该方法线性、精密度高、准确度高、稳扎性好、选择性好、灵敏度高、专属性强,可用于灭司他原料药和片剂的定性和定量测定。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A sensitive, precise, accurate, and economic planar chromatographic method developed and validated for quantification of Desidustat as per guideline
Anemia with chronic kidney disease treating newer hope is recently approved Desidustat. By following International Conference on Harmonization Quality guideline Q2 (R1), an economic high‐performance thin‐layer chromatography method has been developed for the estimation of Desidustat. Pre‐coated silica gel 60 F254 plates as stationary phase along with mobile phase toluene:methanol:glacial acetic acid (7.5:2.5:0.3 v/v/v), and 230 nm detection wavelength was selected as optimized. Developed method was found linear in quantity per band range of 100 ng/band to 600 ng/band for Desidustat with 0.9979 regression coefficient. Standard spiking method showed method accuracy with a mean percentage recovery of 99.21%–101.63%. Limit of detection and limit of quantitation were found to be 3.94 and 11.94 ng/band, respectively. The method was found to be linear, precise, accurate, robust, rugged, selective, sensitive, and specific for the quantification of Desidustat in bulk and tablet dosage form and successfully can be applied for the qualitative and quantitative determination of Desidustat in bulk and marketed tablet formulation.
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来源期刊
SEPARATION SCIENCE PLUS
SEPARATION SCIENCE PLUS CHEMISTRY, ANALYTICAL-
CiteScore
1.90
自引率
9.10%
发文量
111
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