Ashour Safwan, Bahbouh Mahmoud, Khateeb Mouhammed
Department of Chemistry, Faculty of Sciences, University of Aleppo, Aleppo, Syria;
Int J Biomed Sci. 2010 Mar;6(1):19-26.
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.
本文描述了一种简单、准确且可靠的动力学分光光度法,用于测定纯品及药物制剂中的氟伐他汀钠(FVS)。该方法基于在55±2℃的丙酮介质中,FVS与4-氯-7-硝基苯并呋咱(NBD-Cl)形成有色产物。通过在462nm处测量吸光度随时间的增加,采用分光光度法跟踪反应。构建校准曲线采用速率数据法和固定时间法。速率数据法和固定时间法的线性范围分别为15.0 - 50.0和10.0 - 90.0μg mL⁻¹。速率数据法和固定时间法的检测限分别为0.017和0.134μg mL⁻¹。所提出的方法已成功应用于药物剂型中氟伐他汀钠的测定,不受辅料干扰。结果的统计比较表明,所提出的方法与官方方法之间没有显著差异。