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紫外分光光度法与高效液相色谱法用于氟桂利嗪分析及其在溶出度试验中的应用比较

Comparison of UV spectrophotometric method and high performance liquid chromatography for the analysis of flunarizine and its application for the dissolution test.

作者信息

Busaranon Kesarin, Suntornsuk Worapot, Suntornsuk Leena

机构信息

Faculty of Pharmacy, Rangsit University, Pratumtani, Thailand.

出版信息

J Pharm Biomed Anal. 2006 Apr 11;41(1):158-64. doi: 10.1016/j.jpba.2005.11.008. Epub 2005 Dec 13.

Abstract

This study aimed to develop a simple UV spectrophotometric method for the analysis and the dissolution test of flunarizine in capsules. The UV absorbance was both measured directly and by the first derivative measurements at 254 and 268 nm, respectively. The developed methods were validated for their linearity, accuracy, precision, limit of detection (LOD) and limit of quantitation (LOQ) in comparison with the reported HPLC method. The UV spectrophotometric method illustrated excellent linearity (r2 > 0.9999) in the concentration range of 6-24 microg/mL. Precision (%R.S.D. < 1.50) and recoveries were good (%R > 99.62). The LOD of direct UV and first derivative measurements were 0.09 and 0.84 microg/mL, respectively, and the LOQ were 0.26 and 2.55 microg/mL, respectively. Results from the assay of flunarizine in capsules by the UV spectrophotometric methods, both direct and first derivative measurements were not significantly different from those of the HPLC method (P > 0.05). Additionally, the method was successfully used for the dissolution test of flunarizine capsule and was found to be reliable, simple, fast, and inexpensive.

摘要

本研究旨在开发一种简单的紫外分光光度法,用于分析氟桂利嗪胶囊并进行其溶出度试验。分别在254和268nm处直接测量紫外吸光度并通过一阶导数测量。与报道的高效液相色谱法相比,对所开发的方法进行了线性、准确度、精密度、检测限(LOD)和定量限(LOQ)的验证。紫外分光光度法在6 - 24μg/mL的浓度范围内表现出良好的线性(r2>0.9999)。精密度(%R.S.D.<1.50)和回收率良好(%R>99.62)。直接紫外测量和一阶导数测量的检测限分别为0.09和0.84μg/mL,定量限分别为0.26和2.55μg/mL。通过紫外分光光度法(直接测量和一阶导数测量)对氟桂利嗪胶囊进行含量测定的结果与高效液相色谱法的结果无显著差异(P>0.05)。此外,该方法成功用于氟桂利嗪胶囊的溶出度试验,且被发现可靠、简单、快速且成本低廉。

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