反相高效液相色谱法测定含有杂质的生理盐水稀释呋塞米注射液中抗利尿剂呋塞米含量的分析方法的建立与验证

A. Karunakaran, Sree Ishwarya Sudharsan, Ramesh Jayaprakash, Senthil Kumar Raju, Sindhuja Venkatachalam, Anjana Elampulakkadu
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引用次数: 1

摘要

本研究旨在建立一种简单、准确、精确、稳健、快速的反相高效液相色谱法测定生理盐水稀释呋塞米注射液中呋塞米的含量,并按照ICH指南中系统适用性、线性度、准确度、精密度、专属性、稳健性和溶液稳定性等参数进行验证。优化后的色谱高效液相色谱分析采用Waters e2695系统,采用Inertsil ODS-3V C18色谱柱(250 cm × 150 mm;5 μ m粒径),以1%冰醋酸与乙腈的混合物为流动相,比例为50%:50% v/v,流速为1.0 mL/min。检测波长为272 nm,速尿的停留时间为7.03 min。在10 ~ 120 ug/mL的浓度范围内,标定图呈线性关系,相关系数r2 = 0.9998。该配方中速尿的纯度为103.56 +/- 0.6546。在给定的配方中,日内和日间的速尿量分别为102.45 +/- 0.2291和102.67 +/- 0.4041。回收率研究表明,该方法的准确度在100.14% ~ 101.01%之间。这表明没有观察到由于配方中使用的赋形剂的干扰。所有参数的RSD百分比均小于2。各杂质峰分离良好,对速尿的保留时间无干扰。鲁棒性、坚固性和溶液稳定性均在可接受范围内。本方法简便、线性、准确、精密度高、稳健性好,可用于生理盐水稀释呋塞米注射液中呋塞米的分析。此外,该方法的主要特点是运行时间短,溶剂消耗少。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Analytical method development and validation for the estimation of Furosemide an anti-diuretic in Furosemide injection diluted with normal saline in presence of impurities by RP-HPLC
This study was aimed to establish a simple, accurate, precise, robust and rapid reverse phase high performance liquid chromatographic method for the estimation of Furosemide in Furosemide injection diluted with normal saline and it was validated as per the parameters mentioned in the ICH guidelines such as system suitability, linearity, accuracy, precision, specificity, ruggedness and robustness and solution stability. The optimized chromatographic HPLC analysis was performed on Waters e2695 system equipped with Inertsil ODS-3V C18 column (250 cm x 150 mm; 5 um particle size), with a mixture of 1% glacial acetic acid and acetonitrile in the ratio of 50%:50% v/v as the mobile phase, at the flow rate of 1.0 mL/min. The detection was performed at the wavelength of 272 nm and the retention time of Furosemide was found to be 7.03 min. The calibration plot gave linear relationship over the concentration range of 10-120 ug/mL with correlation coefficient of r2 = 0.9998. The percentage purity of Furosemide in the given formulation was found to be 103.56 +/- 0.6546. The amount of Furosemide in the given formulation for intraday and interday was found to be 102.45 +/- 0.2291 and 102.67 +/- 0.4041, respectively. The accuracy of the proposed method was determined by recovery studies and was found to be in the range of 100.14% to 101.01%. This indicates that there is no inteference was observed due to excipients used in formulation. The percentage of RSD was found to be less than 2 for all the parameters. All the impurities peak were separated well and no inteference were found with the retention time of Furosemide. The results of robustness, ruggedness and solution stability were found to be within the acceptance limit. Hence, the developed method was found to be simple, linear, accurate, precise, robust, rapid method for the analysis of Furosemide in Furosemide injection diluted with normal saline. In addition, the main feature of the developed method is lower run time with less solvent consumption.
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