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用于测定药物制剂中右布洛芬的高效液相色谱法和紫外分光光度法的开发与验证

Development and Validation of a HPLC and an UV Spectrophotometric Methods for Determination of Dexibuprofen in Pharmaceutical Preparations.

作者信息

Muralidharan Selvadurai, Meyyanathan Subramania Nainar

机构信息

Department of Pharmaceutical Analysis, JSS College of Pharmacy, Ootacamund, Tamilnadu-643 001, India.

出版信息

ISRN Pharm. 2011;2011:948314. doi: 10.5402/2011/948314. Epub 2011 Jul 5.

Abstract

A high-performance liquid chromatographic (HPLC) and a ultraviolet (UV) methods were developed and validated for the quantitative determination of Dexibuprofen (DI) in pharmaceutical dosage form. HPLC was carried out by reversed phase technique on a RP-18 column with a mobile phase composed of acetonitrile and 0.5% triethylamine (pH 7.5 adjusted with orthophosphoric acid (30 : 70, v/v)). UV method was performed with the λ max at 222.0 nm. Both the methods showed good linearity, reproducibility and precision. No spectral or chromatographic interferences from the tablet excipients were found in UV and HPLC. The method was successfully applied to commercial DEXIFEN tablets. Validation parameters such as linearity, precision, accuracy, and specificity were determined. The proposed method could be applicable for routine analysis of DI and monitoring of the quality of marketed drugs.

摘要

建立并验证了高效液相色谱(HPLC)法和紫外(UV)法用于定量测定药物剂型中的右布洛芬(DI)。HPLC采用反相技术,在RP - 18柱上进行,流动相由乙腈和0.5%三乙胺(用正磷酸调节pH值至7.5(30∶70,v/v))组成。UV法在222.0 nm波长处进行。两种方法均显示出良好的线性、重现性和精密度。在UV和HPLC中均未发现片剂辅料产生的光谱或色谱干扰。该方法成功应用于市售的DEXIFEN片剂。测定了线性、精密度、准确度和专属性等验证参数。所提出的方法可适用于DI的常规分析和市售药品质量的监测。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc21/3263711/8363211041bc/PHARMACEUTICS2011-948314.001.jpg

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