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一种用于测定纯品、药物制剂、人血浆和人尿液中伊马替尼的新型荧光分光光度法。

A novel spectrofluorimetric method for determination of imatinib in pure, pharmaceutical preparation, human plasma, and human urine.

作者信息

Zidan Dalia W, Hassan Wafaa S, Elmasry Manal S, Shalaby Abdalla A

机构信息

Aga Health Insurance Hospital, Dakahlia, Egypt.

Analytical Chemistry Department, Pharmacy Faculty, Zagazig University, Egypt.

出版信息

Luminescence. 2018 Feb;33(1):232-242. doi: 10.1002/bio.3406. Epub 2017 Nov 2.

DOI:10.1002/bio.3406
PMID:29094459
Abstract

The following paper represents a simple, highly sensitive, responsive validated and developed spectrofluorimetric method for estimation of imatinib (IMB) in its pure, commercial preparation, human urine and human blood plasma. The calibration curve was in the range 4-900 ng ml for pure form and urine and 8-900 ng ml for plasma in a medium contains carboxymethyl cellulose (CMC) and acetate buffer (pH 5) with excitation wavelength (λ ) 230 nm and emission wavelength (λ ) 307 nm. The limit of detection (LOD) was 0.37 ng ml for the pure form, 0.64 ng ml for human urine, and 0.70 ng ml for human plasma, while the limit of quantitation (LOQ) was 1.2 for pure form, 1.91 for urine and 2.1 for plasma. The suggested method was successfully applied for evaluation of IMB in tablets within 99% mean percentage recovery. The excipients that are usually used as additives in pharmaceutical dosage form did not interfere with the suggested method. The method was efficiently used for estimation of IMB in human urine and human plasma. The effect of some cations that might be present in urine and plasma was also studied. The method was also focused on human volunteers and in vitro drug release.

摘要

以下论文介绍了一种简单、高灵敏度、经过验证且开发的荧光分光光度法,用于测定其纯品、市售制剂、人尿液和人血浆中的伊马替尼(IMB)。在含有羧甲基纤维素(CMC)和醋酸盐缓冲液(pH 5)的介质中,纯品和尿液的校准曲线范围为4 - 900 ng/ml,血浆的校准曲线范围为8 - 900 ng/ml,激发波长(λex)为230 nm,发射波长(λem)为307 nm。纯品的检测限(LOD)为0.37 ng/ml,人尿液为0.64 ng/ml,人血浆为0.70 ng/ml,而定量限(LOQ)纯品为1.2,尿液为1.91,血浆为2.1。所建议的方法成功应用于片剂中IMB的评估,平均回收率在99%以内。通常用作药物剂型添加剂的辅料不会干扰所建议的方法。该方法有效地用于测定人尿液和人血浆中的IMB。还研究了尿液和血浆中可能存在的一些阳离子的影响。该方法还关注人体志愿者和体外药物释放。

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