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简便分光荧光定量法测定奥曲肽(一种合成肽)的纯品和药物制剂;评价该方法的绿色度。

Facile spectrofluorimetric quantitation of octreotide, a synthetic peptide, in its pure form and pharmaceutical formulation; evaluation of the method's greenness.

机构信息

Analytical Chemistry Department, Faculty of Pharmacy, Minia University, Minia, Egypt.

出版信息

Luminescence. 2022 Nov;37(11):1914-1920. doi: 10.1002/bio.4375. Epub 2022 Sep 15.

Abstract

A new, rapid, highly sensitive, and affordable spectrofluorimetric approach has been constructed and validated for the determination of octreotide in its authentic form and pharmaceutical dosage form. Octreotide is an important synthetic analog of the naturally occurring somatostatin hormone. The developed spectrofluorimetric approach is actually dependent on the measurement of octreotide native fluorescence at emission wavelength of 342 nm after excitation at 218 nm. At optimal reaction conditions, the calibration curve has been constructed over the concentration range 200-2000 ng ml , with excellent linearity. The limits of detection and quantitation values were found to be 55 and 169 ng ml , respectively. The developed approach has been effectively used to determine octreotide in its pharmaceutical ampoules, without interference from the excipients in the dosage form. The developed approach is simple, time-saving, and does not require multiple pretreatment steps for samples, costly apparatus, or dangerous materials. As a result, it can be used to detect and quantify octreotide acetate in quality control laboratories.

摘要

一种新的、快速、高灵敏度且经济实惠的荧光分光光度法已被构建并验证,用于测定奥曲肽的真实形式和药物制剂形式。奥曲肽是天然生长抑素激素的一种重要合成类似物。所开发的荧光分光光度法实际上依赖于在 218nm 激发后测量 342nm 处奥曲肽的本征荧光。在最佳反应条件下,在 200-2000ngml 的浓度范围内构建了校准曲线,具有极好的线性。检测限和定量值分别为 55 和 169ngml。该方法已有效地用于测定药物安瓿中的奥曲肽,不会受到制剂中赋形剂的干扰。所开发的方法简单、省时,不需要对样品进行多次预处理步骤、昂贵的仪器或危险的材料。因此,它可用于质量控制实验室中检测和定量奥曲肽醋酸盐。

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