Bioanalytical Method Development and Validation of Estimation of Nimorazole by RP-HPLC in Human Plasma

Nilam B Jadhav, S. Yadav, K. Gusain
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Abstract

Nimorazole is an antiprotozoal medicine used to treat infections caused by protozoa in the stomach, intestines, or genital areas. The main principle of this study was to develop RP-HPLC technique for the quantitative determination of Nimorazole in human plasma. The separation was accomplished by the isocratic method by using column C18 (Thermosil ODS), detection wavelength was 294 nm. The analyte was extracted in acetonitrile by liquid-liquid extraction. Acetonitrile: water in the ratio 30:70 was used as mobile phase for estimation of the drug in human plasma with a flow rate of 0.8 mL/min at a detection wavelength of 294 nm. Retention time was found to be 7.933 ± 0.23 min.The developed method was found to be linear over the concentration range of 60-360 μg/mL, with a correlation coefficient of 0.9991. The LOD and LOQ were found to be 10 μg/mL and 40 μg/mL, respectively. The method ensure for Precision and % RSD was found to be less than 2 % and the mean % recovery was found to be 99.58%. This method was effectively and favourably applied to the plasma samples and it seems to be appropriate tool for regular therapeutic drug monitoring of anti-infective drugs.
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反相高效液相色谱法测定人血浆中尼莫唑含量的生物分析方法的建立与验证
尼莫唑是一种抗原虫药物,用于治疗由胃、肠或生殖器区域的原虫引起的感染。本研究的主要目的是建立反相高效液相色谱法测定人血浆中尼莫唑的含量。色谱柱为C18(Thermosil ODS),检测波长为294 nm,采用等压法分离。分析物采用液-液萃取法在乙腈中提取。以乙腈:水的比例为30:70,流速为0.8 mL/min,检测波长为294 nm,作为药物在人血浆中的流动相预测。在60 ~ 360 μg/mL的浓度范围内,该方法线性良好,相关系数为0.9991。定量限和定量限分别为10 μg/mL和40μg/mL。方法精密度保证,RSD < 2%,平均回收率为99.58%。该方法可有效地应用于血浆样品,是抗感染药物常规治疗药物监测的合适工具。
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