A Validated Reversed‐Phase (C18) HPLC Method for Simultaneous Determination of Rifampicin, Isoniazid and Pyrazinamide in USP Dissolution Medium and Simulated Gastric Fluid

T. Mariappan, Baljinder Singh, Saranjit Singh
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引用次数: 18

Abstract

A liquid-chromatographic reversed-phase method employing a C18 column has been developed for simultaneous analysis of rifampicin, isoniazid and pyrazinamide in 0.1 M hydrochloric acid dissolution medium and in simulated gastric fluid. Good separations were achieved by employing a gradient prepared from methanol and 0.01M sodium dihydrogen orthophosphate buffer containing 0.05% w/v tetramethylammonium chloride (pH adjusted to 3.5). The detection wavelength was 254 nm. The method was validated for linearity, accuracy, precision and ruggedness. It was found to work well for analysis of the three drugs in the presence of degradation products and even for samples containing ethambutol, which does not interfere because of lack of UV absorption.
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反相高效液相色谱法同时测定USP溶出介质和模拟胃液中利福平、异烟肼和吡嗪酰胺的含量
建立了在0.1 M盐酸溶解介质和模拟胃液中同时分析利福平、异烟肼和吡嗪酰胺的C18柱反相液相色谱方法。采用甲醇和含有0.05% w/v四甲基氯化铵(pH调节为3.5)的0.01M正磷酸二氢钠缓冲液制备的梯度分离效果良好。检测波长为254 nm。验证了该方法的线性度、准确度、精密度和耐用性。研究发现,它可以很好地分析存在降解产物的三种药物,甚至可以分析含有乙胺丁醇的样品,由于缺乏紫外线吸收,乙胺丁醇不会干扰。
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