反相高效液相色谱法测定复方富马酸喹硫平含量的建立与验证

P. Nagaraju
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引用次数: 5

摘要

目的:建立一种简便、快速、准确、精确的反相高效液相色谱法测定纯剂型和片剂中喹硫平的含量。材料与方法:采用Waters Xterra C18色谱柱(250x4.6 mm, 5 μ),采用岛津(Shimadzu)高效液相色谱仪进行分离。结果:以缓冲液(9.2±0.05)与乙腈(51:49 v/v)为溶剂,在浓度为50 ~ 150 μg/mL范围内线性响应良好,检测波长为254 nm,流速为1.0 mL/min,保留时间为6.588 min。结论:该方法具有良好的线性、准确度、精密度和选择性。对该剂型进行了定量研究和回收率分析,回收率研究的RSD %小于1。关键词:喹硫平烟马酸酯,等浓度,c18,高效液相色谱法,片剂
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and Validation of RP-HPLC Method for Estimation of Quetiapine Fumarate in Pharmaceutical Formulations
Objective : A simple, rapid, accurate and precise RP-HPLC method was developed for the determination of Quetiapinefumarate in pure and tablet dosage forms. Materials and Methods : Separation of the drug was achieved on aisocratic Shimadzu prominence HPLC instrument on a Waters Xterra C18 column (250x4.6 mm, 5 μ). Results : The method showed a linear response for concentration in the range of 50–150 μg/mL using buffer (9.2 ± 0.05) and acetonitrile in the ratio of 51:49 v/v with detection at 254 nm with a flow rate of 1.0 mL/min and retention time was 6.588 min. Conclusion: The method was statistically validated for linearity, accuracy, precision and selectivity. Quantitative and recovery studies of the dosage form were also carried out and analyzed, the %RSD from recovery studies was found to be less than 1. Key words: Quetiapinefumarate, Isocratic, C 18 , HPLC, Tablets.
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