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首页> 外文期刊>Journal of Young Pharmacists >Simultaneous Method for Quantification of Genotoxic Impurity in the Gemcitabine Hydrochloride by RP-HPLC
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Simultaneous Method for Quantification of Genotoxic Impurity in the Gemcitabine Hydrochloride by RP-HPLC

机译：RP-HPLC法同时测定盐酸吉西他滨中遗传毒性杂质的方法

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Objective: In the pharmaceutical analytical field, effort to analyzing the degradation or related and impurity substances from the complex matrix in the ultra-trace levels is a really a challengeable task. Impurity is any component of the new drug substance that is not the chemical entity defined as the new drug substance. Gemcitabine hydrochloride is a new anticancer bio molecule. According to Indian Pharmacopoeia there is two impurities present in this drug. The literature review exploded that, there is no specific impurity profiling based analytical method developed to estimate the Cytosine. Methods: RP HPLC is developed to quantify and separate Gemcitabine hydrochloride and Cytosine. The Hibar? Csup18/sup (250 x 4.6 mm i.d., 5μ), Column choices as stationary phase, tri ethyl ether and Acetonitrile in ratio of 95:5 with 4.35 (with Orthophosphoric acid) as mobile phase, the flow rate fixed as 1ml/ min. at 279 nm. Results: A retention time found to be 3.44min and 8.28min for gemcitabine and cytosine respectively. The developed method was validated as per ICH guidelines and the method was proved as selective, specific and linear. The assay and recovery studies were carried out the assay limit was 99.19 and 99.32 for bulk drug and formulations respectively. The Cytosine were present 0.7821 μg/ml and 0.6531 μg/ml in the bulk drug and formulation respectively. Conclusion: It can be concluded that the developed RP-HPLC method was found to be suitable for the appraisal of cytosine impurities in Gemcitabine HCl. The developed RP-HPLC is economic and suitable for the use.
机译：目的：在药物分析领域，从超痕量水平分析复杂基质中降解或相关及杂质物质的工作确实是一项艰巨的任务。杂质是新原料药的任何组成部分，不是定义为新原料药的化学实体。盐酸吉西他滨是一种新型的抗癌生物分子。根据印度药典，该药物中存在两种杂质。文献综述表明，目前尚无基于特定杂质分析的分析方法来估算胞嘧啶。方法：RP HPLC用于定量分离盐酸吉西他滨和胞嘧啶。 Hibar？ C 18 （250 x 4.6 mm内径，5μ），色谱柱选择为固定相，三乙醚和乙腈的比例为95：5，流动相为4.35（含正磷酸），流速固定为1毫升/分钟。在279 nm结果：吉西他滨和胞嘧啶的保留时间分别为3.44min和8.28min。所开发的方法已按照ICH指南进行了验证，并且该方法被证明具有选择性，特异性和线性。进行了测定和回收率研究，散装药物和制剂的测定极限分别为99.19和99.32。在原料药和制剂中，胞嘧啶的含量分别为0.7821μg/ ml和0.6531μg/ ml。结论：可以得出结论，认为所开发的RP-HPLC方法适用于盐酸吉西他滨中胞嘧啶杂质的鉴定。研发的RP-HPLC经济且适合使用。

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