方法:采用反相高效液相色谱法对利福平在制剂中的含量进行测定和验证

Gadi Vijaya, Lakshmi, B. Dileep, K.Sirisha, M.Vijaya Snehitha, T.T.J.S. Srinivasa Guptha
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引用次数: 0

摘要

建立了一种快速、灵敏的紫外检测(219nm)反相高效液相色谱(RP-HPLC)方法,用于中药制剂中利福平的常规分析。色谱采用流动相,甲醇含量为99.8%,流速为0.9ml/min。采用内标法定量。验证了方法的线性(相关系数= 0.9957)、准确度和日内检出限(LOD)精密度。考察利福平的线性度、精密度和检出限三个因素,其中流动相为甲醇,流速为0.9ml/min,压力为1200帕斯卡。为了确保精确的日内测量,考虑的变量是分析人员和设备。RSD值为0.20%,表明该方法精密度高。该方法简单;该方法灵敏度高,精密度高,准确度高,保留时间小于3 min,可用于常规质量控制。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Method Development and Validation of Rifampicin by Using RP-HPLC Method in Pharmaceutical Formulations
A rapid and sensitive RP-HPLC method with UV detection (219nm) for routine analysis of Rifampicin in a pharmaceutical formulation was developed. Chromatography was performed with a mobile phase containing a methanol of assay (99.8%) with flow rate of 0.9ml/min. Quantitation was accomplished with an internal standard method. The procedure was validated for linearity (correlation coefficient = 0.9957), accuracy and limit of detection (LOD) intraday precision. To test validation of the Rifampicin three factors were considered as linearity, precision, LOD where mobile phase, flowrate and pressure are respectively selected as methanol, 0.9ml/min, 1200 pascals. To ensure precise intraday measurements, the variables taken into account were the analyst and the equipment. The RSD value (0.20%) indicated a good precision of the analytical method. The proposed method was simple; highly sensitive, precise, accurate and retention time less than 3 min indicating that the method is useful for routine quality control.
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