反相高效液相色谱法测定原料药和制剂中柔红霉素和阿糖胞苷含量的稳定性指示方法的建立与验证

Uma Maheswari Katari, M. Ajitha
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引用次数: 0

摘要

建立了一种简便、准确、精密度高的RPHPLC同时测定柔红霉素和阿糖胞苷原料药和制剂制剂中含量的方法。采用Zorbax C18 (150mm × 4.6 mm, 5μ粒径)标准色谱。流动相含缓冲液0.01N KH2PO4:乙腈,比例为60:40,以1.0 ml/min的流速泵入柱中。本方法所用缓冲液为0.01N KH2PO4缓冲液。温度设定为30摄氏度。优选波长为240.0 nm。阿糖胞苷和柔红霉素的保留时间分别为2.325 min和3.208 nm。柔红霉素和阿糖胞苷的% RSD分别为0.6和0.6。柔红霉素和阿糖胞苷的回收率分别为100.30%和100.33%。通过回归方程得到柔红霉素和阿糖胞苷的LOD、LOQ分别为0.09、0.28和0.32、0.97。柔红霉素和阿糖胞苷的回归方程分别为y=39589X+28710和y=32928X+12457,保留时间缩短,运行次数减少,简便经济,可用于工业常规质量控制试验。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Stability Indicating Method Development and Validation for Determination of Daunorubicin and Cytarabine in Bulk and Pharmaceutical Dosage Form by RP-HPLC
A Simple, Accurate and Precise method was developed for the simultaneous estimation of Daunorubicin and Cytarabine in bulk and pharmaceutical dosage form by RPHPLC technique. Chromatogram was run through standard Zorbax C18 (150mm x 4.6 mm, 5μ particle size). Mobile phase containing buffer 0.01N KH2PO4: Acetonitrile taken in the ratio of 60:40 was pumped through column at a flow rate of 1.0 ml/min. Buffer used in this method was 0.01N KH2PO4 buffer. Temperature was set to 30C. Optimized wavelength selected was 240.0 nm. Retention time of Cytarabine and Daunorubicin were found to be 2.325 min and 3.208 nm. % RSD of Daunorubicin and Cytarabine were found to be 0.6 and 0.6 respectively. %Recovery was obtained as 100.30% and 100.33% for Daunorubicin and Cytarabine respectively. LOD, LOQ values obtained from regression equation of Daunorubicin and Cytarabine were 0.09, 0.28 and 0.32, 0.97 respectively. The regression equation of Daunorubicin and Cytarabine is y=39589X+28710 and y=32928X+12457 respectively Retention times were decreased and that run was decreased, so the method was simple and economical that can be adopted in regular Quality control test in Industries.
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