紫外分光光度法和液相色谱法测定头孢匹罗原料药和药量的方法建立与验证

T. P. Oppe, Júlia Menegola, E. Schapoval
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引用次数: 6

摘要

本文建立了第四代广谱头孢菌素头孢匹罗的定量分析方法——紫外分光光度法和液相色谱法。以0.1 M盐酸为溶剂,在271 nm波长下进行紫外分光光度法。HPLC柱为Techsphere ODS,流动相为甲醇-水(30:70,v/v),流速为0.8 mL/min,紫外检测波长为265 nm。验证结果表明,该方法具有良好的线性、精密度、准确度、专属性和鲁棒性。对头孢匹罗的稳定性进行了初步研究,结果表明紫外分光光度法和液相色谱法对头孢匹罗降解产物的测定具有特异性。不同方法间无统计学差异。紫外分光光度法和液相色谱法可以定量测定头孢匹罗在制剂剂型和原料中的含量,可用于常规质量控制中的药物分析。
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 UV SPECTROPHOTOMETRY AND LIQUID CHROMATOGRAPHY METHODS FOR DETERMINATION OF CEFPIROME IN RAW MATERIAL AND PHARMACEUTICAL DOSAGE
In the present work, analytical methods, UV Spectrophotometry and Liquid Chromatography (HPLC), were developed and validated for quantification of cefpirome, a broad-spectrum fourth-generation cephalosporin, in raw material and powder for injectable preparation. The UV spectrophotometric method was performed at 271 nm, using 0.1 M hydrochloric acid as solvent. The HPLC was carried out using Techsphere ODS column and mobile phase consisted of methanol-water (30:70, v/v) with flow rate 0.8 mL/min and UV detection at 265 nm. The validation method yielded good results demonstrated statistically that the methods were linear, precise, accurate, specific and robust. A preliminary stability study of cefpirome showed that the UV Spectrophotometry and Liquid Chromatography methods were specific for the determination cefpirome in the presence of its degradation products. No statistically difference was observed between the proposed methods. The UV Spectrophotometry and Liquid Chromatography methods allow the quantitation of cefpirome in pharmaceutical dosage form and raw material and can be used for the drug analysis in routine quality control. 
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