测定散装和制剂中伊德拉利西的衍生分光光度法

IF 0.8 4区 化学 Q4 SPECTROSCOPY Journal of Applied Spectroscopy Pub Date : 2024-07-04 DOI:10.1007/s10812-024-01772-2
Marella Mahesh, Alka Bali, Tanvi Gupta, Sudhanshu Shekhar
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引用次数: 0

摘要

伊德拉利西是一种磷脂酰肌醇3-激酶δ抑制剂,经美国食品药品管理局(FDA)和欧洲药品管理局(EMA)批准用于治疗淋巴溶解性淋巴瘤、B细胞非霍奇金淋巴瘤和淋巴细胞淋巴瘤。本报告介绍了一种简单、快速、灵敏且经济有效的零阶和一阶导数分光光度法,用于估算散装和上市制剂中的伊德拉利西。在甲醇中对该药物进行了初步分光光度分析,共考虑了 12 种参数变化。所选的三种方法变体采用了峰-零和峰-峰技术,评估了它们在药物应力降解溶液中的稳定性和显示潜力。所开发的方法在线性、准确度、精密度和稳健性方面都得到了验证。在 1.0-60.0 μg/mL 的浓度范围内,线性关系良好,相关系数为 0.9997。该方法的检出限为 0.42-3.11 μg/mL,定量限为 1.29-9.42 μg/mL。采用所提出的方法对该药物的上市片剂进行了定量分析,获得了 95.98% 至 98.81% 的良好回收率。
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Derivative Spectrophotometric Methods for Determination of Idelalisib in Bulk and in Formulation

Idelalisib is a phosphatidylinositol 3-kinase delta inhibitor approved by the FDA and the EMA for the treatment of lympholytic lymphoma, B cell non-Hodgkin lymphoma, and lymphocytic lymphoma. The present report describes the validation of a simple, rapid, sensitive, and cost-effective zero-order and first-order derivative spectrophotometric method for the estimation of idelalisib in bulk and in its marketed formulation. Preliminary spectrophotometric analysis of the drug was carried out in methanol and a total of 12 parametric variations were considered. Three selected method variants employing peak-zero and peak-peak techniques were assessed for their stability indicating potential in stress degraded solutions of the drug. The developed method was validated with respect to linearity, accuracy, precision, and robustness. Excellent linearity was observed within the concentration range 1.0–60.0 μg/mL with a correlation coefficient of 0.9997. The limits of assay detection values were found for the range 0.42–3.11 μg/mL, and quantitation limits ranged from 1.29 to 9.42 μg/mL for the proposed method variants. The proposed method was used to quantify the drug in its marketed tablet formulation, and good recoveries ranging from 95.98 to 98.81% were obtained.

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来源期刊
CiteScore
1.30
自引率
14.30%
发文量
145
审稿时长
2.5 months
期刊介绍: Journal of Applied Spectroscopy reports on many key applications of spectroscopy in chemistry, physics, metallurgy, and biology. An increasing number of papers focus on the theory of lasers, as well as the tremendous potential for the practical applications of lasers in numerous fields and industries.
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