High Performance Liquid Chromatography Method Development and Validation for Separation of Liothyronine Sodium Related Substances Using a Quality by Design Approach

Scholars Academic Journal of Pharmacy Pub Date : 2023-02-08 DOI:10.36347/sajp.2023.v12i02.002

Ö. Temiz, Soner Turan, Şebnem Sarışan İçen, Gönül Kayar

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Abstract

The application of the Quality by Design (QbD) principles in developing a novel high performance liquid chromatography (HPLC) method for the analysis of liothyronine sodium related substances for finished product using Fusion QbD® software is explored. The effect of various chromatographic parameters including, column stationary phase, initial hold time and gradient time on separations were systematically investigated. Results show that optimal separations of these compounds in a standard solution can be achieved using a X Bridge C18 column (150 mm × 4.6 μm, 5m), maintained at sample temperature 15°C by using pH 2.0 buffer solution as mobile phase-A and methanol as mobile phase-B with a flow rate of 1.0 ml/min at 225 nm of detection and a gradient time of 38 minutes. The injection volume is 200 μl. Pre-validation studies of the method were performed and all the parameters met the acceptance criteria. The results are demonstrated that optimized method is selective, linear, precise, repeatable and accurate.

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质量设计法分离碘甲状腺原氨酸钠相关物质的高效液相色谱方法的建立与验证

应用设计质量(QbD)原则开发一种新型高效液相色谱(HPLC)方法，利用Fusion QbD®软件分析成品中碘甲状腺原氨酸钠相关物质。系统地考察了柱固定相、初始保持时间和梯度时间等色谱参数对分离的影响。结果表明，在标准溶液中，采用X Bridge C18色谱柱(150 mm × 4.6 μm, 5m)，以pH 2.0的缓冲溶液为流动相a，甲醇为流动相b，流速为1.0 ml/min, 225 nm检测，梯度时间为38 min，样品温度为15℃，可获得最佳的分离效果。注射量为200 μl。对该方法进行了预验证研究，所有参数均符合验收标准。结果表明，优化方法具有选择性好、线性好、精密度高、重复性好、准确度高的特点。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Scholars Academic Journal of Pharmacy

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