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首页> 美国卫生研究院文献>Scientia Pharmaceutica >Simple and Sensitive Stability-Indicating Ion Chromatography Method for the Determination of Cyclopropylamine in Nevirapine and Moxifloxacin Hydrochloride Drug Substances
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Simple and Sensitive Stability-Indicating Ion Chromatography Method for the Determination of Cyclopropylamine in Nevirapine and Moxifloxacin Hydrochloride Drug Substances

机译：简单灵敏的指示性离子色谱法测定奈韦拉平和盐酸莫西沙星药物中的环丙胺

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摘要

A simple and sensitive ion chromatography method has been developed for the determination of cyclopropylamine (CPA) in nevirapine (NEV) and moxifloxacin HCl (MOX) pharmaceutical drug substances. Efficient chromatographic separation was achieved on a Metrosep C4, 5 μm (250 mm × 4.0 mm) column. The mobile phase consists of 5 mM hydrochloric acid containing 10% (v/v) acetonitrile and was delivered in an isocratic mode at a flow rate of 0.9 mL min−1 at 27°C. A conductometric detector was used for the detection of the analyte. The drug substances were subjected to stress conditions including oxidation, thermal, photolytic and humidity for the evaluation of the stability-indicating nature of the method. The method was validated for specificity, precision, linearity, accuracy and solution stability. The limit of detection (LOD) and limit of quantification (LOQ) values are 0.10 μg mL−1 and 0.37 μg mL−1 respectively. The linearity range of the method is between 0.37 μg mL−1 and 1.5 μg mL−1 and the correlation coefficient is found to be 0.9971. The average recoveries of CPA in NEV and MOX are 97.0% and 98.0%, respectively.
机译：已经开发了一种简单灵敏的离子色谱方法，用于测定奈韦拉平（NEV）和盐酸莫西沙星（MOX）药用药物中的环丙胺（CPA）。在Metrosep C4 5μm（250 mm×4.0 mm）色谱柱上实现了高效色谱分离。流动相由含有10％（v / v）乙腈的5 mM盐酸组成，在27°C下以等度模式以0.9 mL min -1 的流速输送。电导检测器用于检测分析物。使药物物质经受包括氧化，热，光解和湿度的应激条件，以评估该方法的稳定性指示性质。验证了该方法的特异性，精密度，线性，准确性和溶液稳定性。检测限（LOD）和定量限（LOQ）值分别为0.10μgmL -1 和0.37μgmL -1 。该方法的线性范围在0.37μgmL -1 和1.5μgmL -1 之间，相关系数为0.9971。 NEV和MOX中CPA的平均回收率分别为97.0％和98.0％。

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