Development of a validated high-performance liquid chromatographic method for the determination of Lurasidone in pharmaceuticals

Marmara Pharmaceutical Journal Pub Date : 2017-12-01 DOI:10.12991/MPJ.2017.32

Sakine Atila Karaca, Duygu Yeniceli Uğur

引用次数: 3

Abstract

A new, rapid and simple HPLC method for determination of Lurasidone in its tablets has been developed and validated. Lurasidone and internal standard (Chlorpromazine) was separated on a Zorbax XDB C8 column (4.6 x 50 mm, 3.5 μm particle size) set at 40°C and quantified by ultraviolet detection at 230 nm. The mobile phase was phosphate buffer (pH:3, 20 mM): acetonitrile: methanol (55:10:35, v/v/v) with a flow rate of 1.2 mL/min. Retention times of Chlorpromazine and Lurasidone was 4.73 and 6.89 minutes, respectively. The method was found linear over the concentration range of 0.5-50 μg/mL Lurasidone. Limit of detection and quantification values for Lurasidone was 0.1295 and 0.4317 μg/mL, respectively. The intra- and inter day precisions were less than 2% and the mean recoveries were 100.32%, which indicated that the method was precise and accurate. All other validation parameters were found within acceptable limits. The validated method has been successfully applied for determination of Lurasidone in its tablets. Keywords:

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建立高效液相色谱法测定药物中鲁拉西酮的方法

建立了一种快速简便的高效液相色谱法测定鲁拉西酮片剂中鲁拉西酮的含量。鲁拉西酮和内标氯丙嗪在Zorbax XDB C8色谱柱(4.6 × 50 mm, 3.5 μm粒度)上分离，柱温为40°C，紫外检测波长为230 nm。流动相为磷酸缓冲液(pH: 3,20 mM):乙腈:甲醇(55:10:35,v/v/v)，流速为1.2 mL/min。氯丙嗪和鲁拉西酮的保留时间分别为4.73和6.89 min。在0.5 ~ 50 μg/mL鲁拉西酮浓度范围内，该方法线性良好。鲁拉西酮的检出限和定量值分别为0.1295和0.4317 μg/mL。日内、日间精密度小于2%，平均加样回收率为100.32%，表明该方法精密度高、准确度高。所有其他验证参数均在可接受范围内。该方法可用于鲁拉西酮片剂的含量测定。关键词:

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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来源期刊

Marmara Pharmaceutical Journal

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