高效液相色谱法和紫外分光光度法测定药物制剂中德西布洛芬含量的建立与验证。

ISRN Pharmaceutics Pub Date : 2011-01-01 Epub Date: 2011-07-05 DOI:10.5402/2011/948314
Selvadurai Muralidharan, Subramania Nainar Meyyanathan
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引用次数: 5

摘要

建立了高效液相色谱法(HPLC)和紫外分光光度法(UV)测定药物剂型德西布洛芬(DI)的方法,并进行了验证。HPLC色谱柱为RP-18,流动相为乙腈和0.5%三乙胺(pH 7.5,正磷酸调节pH (30:70, v/v))。紫外分光光度法,λ max在222.0 nm。两种方法均具有良好的线性、重现性和精密度。在紫外和高效液相色谱中未发现片剂辅料的光谱和色谱干扰。该方法成功地应用于市售DEXIFEN片。确定了验证参数,如线性、精密度、准确度和特异性。该方法可用于DI的常规分析和上市药品的质量监测。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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

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

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

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.

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