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Kinetic Spectrophotometric Determination of Fluvastatin in Pharmaceutical Preparations

机译:动力学光度法测定药物制剂中的氟伐他汀

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摘要

Simple, accurate and reliable kinetic spectrophotometric method for the determination of fluvastatin sodium (FVS) in pure form and pharmaceutical formulations has been described. The method is based on the formation of colored product between FVS and 4-chloro-7-nitrobenzofurazan (NBD-Cl) in acetone medium at 55 ± 2ºC. The reaction is followed spectrophotometrically by measuring the increase in absorbance at 462 nm as a function of time. The rate data and fixed time methods were adopted for constructing the calibration curves. The linearity ranges were found to be 15.0–50.0 and 10.0–90.0 μg mL−1 for rate data and fixed time methods, respectively. The limit of detection for rate data and fixed time methods is 0.017 and 0.134 μg mL−1, respectively. The proposed methods have been successfully applied to the determination of fluvastatin sodium in pharmaceutical dosage forms with no interference from the excipients. Statistical comparison of the results shows that there is no significant difference between the proposed and official methods.
机译:简单,准确,可靠的动力学分光光度法测定纯形式和药物制剂中的氟伐他汀钠(FVS)的方法已经描述。该方法基于在55±2ºC的丙酮介质中FVS和4-氯-7-硝基苯并呋喃山(NBD-Cl)之间形成有色产物。通过分光光度法通过测量462nm处的吸光度随时间的增加来跟踪反应。采用速率数据和固定时间方法建立校正曲线。速率数据和固定时间方法的线性范围分别为15.0–50.0和10.0–90.0μgmL -1 。速率数据和固定时间方法的检出限分别为0.017和0.134μgmL -1 。所提出的方法已成功地用于药物剂型中氟伐他汀钠的测定,而不受辅料的干扰。结果的统计比较表明,建议的方法与官方方法之间没有显着差异。

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