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首页> 外文期刊>Journal of Basic and Applied Sciences >Lifescience Global :: Abstract : Development and Validation of a RP-HPLC Method for Simultaneous Determination of Levofloxacin and Moxifloxacin in Pharmaceutical Dosage Forms
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Lifescience Global :: Abstract : Development and Validation of a RP-HPLC Method for Simultaneous Determination of Levofloxacin and Moxifloxacin in Pharmaceutical Dosage Forms

机译：RP-HPLC法同时测定药物剂型中的左氧氟沙星和莫西沙星的开发和验证

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摘要

A simple, fast and economic reversed phase high performance liquid chromatographic (HPLC) method has been successfully developed and validated for simultaneous determination of fluoroquinolone analogs namely levofloxacin and moxifloxacin in both pure form (as API) and in pharmaceutical dosage forms. The method was validated according to the guidelines of ICH, FDA and USP with respect to accuracy, precision and linearity. For method development a C-18 bonded silica column (250 x 4.6 mm, 5??, Phenomenex, Inc) was used with a mobile phase comprising of 10% aqueous solution of acetic acid and acetonitrile in a ratio of 80:20 v/v. The flow rate was 0.5 mL/min and effluents were monitored at 300 nm and the retention times were found to be at 7.0?±0.1 min and 10.59?±0.1 min for levofloxacin and moxifloxacin, respectively. The recovery was found to be more than 99% for each spiked samples of levofloxacin and moxifloxacin, demonstrating the accuracy of the protocol. Intra-day and inter-day precisions of the new method were less than the maximum allowable limit (RSD% ?￡ 2.0) according to FDA. The method showed linear response with correlation coefficient value of 0.9975 in both the cases.
机译：已成功开发出一种简单，快速且经济的反相高效液相色谱（HPLC）方法，并已验证可同时测定纯形式（作为API）和药物剂型的氟喹诺酮类似物，即左氧氟沙星和莫西沙星。该方法已根据ICH，FDA和USP的指导原则在准确性，精度和线性方面进行了验证。为了进行方法开发，使用了C-18键合硅胶柱（250 x 4.6 mm，5英寸，Phenomenex，Inc），流动相包括比例为80:20 v / V的10％乙酸和乙腈水溶液。 v。流速为0.5 mL / min，在300 nm处监测流出液，发现左氧氟沙星和莫西沙星的保留时间分别为7.0±0.1分钟和10.59±0.1分钟。发现每个加标的左氧氟沙星和莫西沙星样品的回收率均超过99％，证明了方案的准确性。根据FDA的规定，新方法的日内和日间精度低于最大允许极限（RSD％≤2.0）。在两种情况下，该方法均显示线性响应，相关系数值为0.9975。

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