稳定性指示紫外分光光度法测定甲磺酸伊马替尼原料药和制剂的方法建立及验证

R. Sri, Soundarya Soundarya, K. B. Sri, S. M
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引用次数: 2

摘要

建立了甲磺酸伊马替尼原料药和制剂中甲磺酸伊马替尼含量的紫外光谱测定方法。根据USP通章和ICH Q2R1指南,对所开发的方法进行了特异性、准确性、线性、稳健性等各种参数的验证。对甲磺酸伊马替尼纯溶液进行全紫外扫描,在258nm处吸光度最大。方法精密度和中间精密度的RSD值均在可接受标准范围内,稀释度系列呈线性(2 ~ 12ug/ml),回归值r2= 0.999。建立了IMT的检测限(0.2925μg/ml)和定量限(0.8977μg/ml)。此外,该药物已受到各种压力条件,和百分比降解的报道。药物溶液在实验台上的稳定性可达8小时,冷藏后可达72小时。
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Stability Indicating UV-Spectrophotometric Method Development and its Validation for the Determination of Imatinib Mesylate in Bulk and Formulation
A Simple and precise UV-spectroscopic method was developed for the determination of Imatinib Mesylate in its bulk and formulation. The developed method has been validated for various parameters like specificity, accuracy, linearity, robustness according to USP general chapter<1225> and ICH Q2R1 guidelines. Pure solution of Imatinib Mesylate was scanned in the whole range of UV region where it has shown the maximum absorbance at 258nm. The RSD values for method precision and intermediate precision were found to be well within the acceptance criteria and the series of dilutions were found to be linear (2-12ug/ml) where r2= 0.999 was the regression value. Limit of detection (0.2925μg/ml) and Limit of quantification (0.8977μg/ml) of IMT were established. Further, the drug has been subjected to various stress conditions, and percent degraded was reported. Drug solutions have shown stability on the benchtop for up to 8 hours and 72 hours when the solutions were refrigerated.
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