QUANTITATIVE DETERMINATION OF LAMOTRIGINE BY GAS CHROMATOGRAPHY USING ETHYL CHLOROFORMATE AS A DERIVATIZING REAGENT IN PURE AND PHARMACEUTICAL PREPARATION

QUANTITATIVE DETERMINATION OF LAMOTRIGINE BY GAS CHROMATOGRAPHY USING ETHYL CHLOROFORMATE AS A DERIVATIZING REAGENT IN PURE AND PHARMACEUTICAL PREPARATION
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纯品和药物制剂中以氯甲酸乙酯为衍生化试剂的气相色谱法定量测定拉莫三嗪

DOI:
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发表时间:
2013
期刊:
Indo American Journal of Pharmaceutical Research
影响因子:
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通讯作者:
M. Indupriya
M. Indupriya
中科院分区:
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文献类型:
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作者:
R. Chandan;B. Gurupadayya;M. Indupriya

文献摘要

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建立了一种新的测定原料药和药物剂型中拉莫三嗪(LMT)含量的方法。以氯甲酸乙酯(ECF)为柱前衍生试剂。色谱柱为RTX-5毛细管柱(交联型5%二苯基/95%二甲基聚硅氧烷),柱长30m,内径0.25 mm,火焰离子化检测器。洗脱初始温度为80˚C,洗脱时间为4分钟,升温速率为100˚C/分钟至180˚C,洗脱时间为5分钟。柱压为29.8kpa,3.5min,压力以20kpa/min的速度上升至120kpa,4.50min。LMT的线性范围为2~10 ng/ml,用于药物制剂中LMT的测定。相对标准偏差RSD为0.17%。进行了回收率研究,LMT的回收率为97.86%。
Article history A novel Gas Chromatographic (GC) method has been developed for the quantitative estimation of Lamotrigine (LMT) in bulk drug and pharmaceutical dosage forms. Ethyl chloroformate (ECF) was used as a precolumn derivatizing reagent. GC separation was carried out on an Rtx-5 capillary column (cross bond 5% diphenyl/95% dimethyl polysiloxane) with a length of 30 meters and an internal diameter of 0.25 mm with flame ionization detector. The elution was carried out at an initial temperature of 80˚ C for 4 minutes and temperature increased at the rate of 100˚C/min up to 180˚C for 5min. Column pressure was programmed as 29.8 Kpa for 3.5 minutes and pressure increased at rate of 20Kpa/min up to 120Kpa for 4.50 minutes. The linear calibration ranges for LMT was observed between 2- 10 ng/ml. The method was subsequently applied to the determination of LMT in pharmaceutical preparations. The relative standard deviation (RSD) was found to be 0.17%. The recovery studies were done and the percentage recovery of LMT was found to be 97.86%.