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采用经验证的高效薄层色谱法对藏红花提取物和纳米粒制剂中亚藏红花醛的定量分析。

Quantitative analysis of safranal in saffron extract and nanoparticle formulation by a validated high-performance thin-layer chromatographic method.

机构信息

Department of Pharmaceutics, Faculty of Pharmacy, Hamdard University, New Delhi-110062, India.

出版信息

Phytochem Anal. 2010 May-Jun;21(3):219-23. doi: 10.1002/pca.1184.

Abstract

INTRODUCTION

Safranal is an effective anticonvulsant shown to act as an agonist at GABA(A) receptors. Nose to brain delivery via nanoparticle formulation might improve its brain delivery. A selective and sensitive analytical method is required for evaluation of safranal-based novel drug delivery systems.

OBJECTIVE

To develop and validate a high-performance thin-layer chromatographic (HPTLC) method for the quantitative analysis of safranal as bulk, in saffron extract and in developed safranal-loaded nanoparticle formulation.

METHODOLOGY

Chromatographic separation was achieved on silica gel pre-coated TLC aluminium plates 60F-254, using n-hexane:ethyl acetate (9 : 1, v/v) as the mobile phase. Quantitative analysis was carried out by densitometry at a wavelength of 310 nm. The method was validated and applied to detect related impurities, to analyse safranal in saffron extract and to evaluate safranal-loaded nanoparticles.

RESULTS

Compact spots of safranal were observed at R(f) value 0.51 +/- 0.02. The method was linear (r = 0.9991) between 0.5 and 5.0 ng/spot. The intra- and inter-day precisions were 1.08-2.17 and 1. 86-3.47%, respectively. The limit of detection was 50 ng/spot and the limit of quantification was 150 ng/spot. The method proved to be accurate (recovery 97.4-102.0%) and was selective for safranal. Evaluation of safranal-loaded nanoparticle formulation demonstrated drug loading of 23.0%, encapsulation efficiency of 42.0% and sustained drug release following biphasic pattern.

CONCLUSION

The present method is useful for the quantitative and qualitative analysis of safranal and safranal-loaded nanoparticle formulation. It provides significant advantages in terms of greater specificity and rapid analysis.

摘要

简介

藏红花醛是一种有效的抗惊厥药物,被证明是 GABA(A) 受体的激动剂。通过纳米粒制剂经鼻递药可能会改善其脑内传递。因此需要一种选择性和灵敏的分析方法来评估基于藏红花醛的新型药物传递系统。

目的

建立并验证一种高效薄层色谱(HPTLC)法,用于藏红花醛原料药、藏红花提取物和藏红花醛载药纳米粒制剂的定量分析。

方法

采用硅胶预制薄层板 60F-254,以正己烷-乙酸乙酯(9:1,v/v)为展开剂,在 310nm 波长处进行色谱扫描,用积分薄层色谱法定量。对该方法进行了验证,并用于检测相关杂质,分析藏红花提取物中的藏红花醛,以及评估藏红花醛载药纳米粒。

结果

藏红花醛的斑点在 R(f)值为 0.51±0.02 处得到很好的分离。该方法在 0.5-5.0ng/斑点范围内线性良好(r=0.9991)。日内和日间精密度分别为 1.08-2.17%和 1.86-3.47%。检测限为 50ng/斑点,定量限为 150ng/斑点。该方法准确(回收率 97.4-102.0%),对藏红花醛具有专属性。藏红花醛载药纳米粒制剂的评价表明,载药量为 23.0%,包封率为 42.0%,且呈双相释药模式。

结论

本方法可用于藏红花醛原料药和藏红花醛载药纳米粒制剂的定量和定性分析,具有特异性强、分析速度快等显著优势。

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