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首页> 外文期刊>Pharmaceutical Methods >A Validated RP-HPLC-UV Method for Identification of Reference Standards of Degradation Products of Fenofibrate
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A Validated RP-HPLC-UV Method for Identification of Reference Standards of Degradation Products of Fenofibrate

机译：一种有效的RP-HPLC-UV方法鉴定非诺贝特降解产物参考标准

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Background: During the stress degradation studies of Fenofibrate the structures of two major degradation products,namely 2-[4-(4-chlorobenzoyl)phenoxy]-2-methyl propanoic acid and methyl 2-[4-(4-chlorobenzoyl) phenoxy]-2-methylpropanoate, were characterized using LC-MS/MS studies under alkaline and acidic hydrolytic conditions,respectively. The present communication deals with synthesis, spectral characterization and further application of thosereference standards of degradation products in identification of degradation products in bulk sample of drug through retentiontime matching studies. Methods: The reference standards of the degradation products were synthesized in the laboratoryand their identity were confirmed using spectral studies. These were employed for retention matching studies using HPLCstudies. The chromatographic conditions were as follows: stationary phase: Waters X Bridge C18 column (250x4.6 mm,internal diameter, particle size 5 μm), mobile phase: acetonitrile: water in 75:25 v/v, column oven temperature: ambient.The chromatograms were monitored at 286 nm with a flowrate of 1 mL/min. The method was validated according tothe ICH guidelines. Results: Retention time values of synthesized reference standards were found to be identical withretention time values of those degradation products in stressed samples. The calibration curves showed good linearregression (r2>0.999) within test ranges. The method showed good reproducibility and sensitivity for quantification ofboth degradation products in samples. Method was precise and %recovery of both reference products was within 98-102%. Conclusion: This communication emphasizes use of non-compendial reference standards for quantification ofdegradation products by chromatographic methods. Quantitative validation parameters like Limit of detection and Limitof quantitation were established.
机译：背景：在非诺贝特的应力降解研究中，两种主要降解产物的结构为2- [4-（4-氯苯甲酰基）苯氧基] -2-甲基丙酸和甲基2- [4-（4-氯苯甲酰基）苯氧基]使用LC-MS / MS研究分别在碱性和酸性水解条件下表征了-2-甲基丙酸酯。本交流内容涉及合成，光谱表征以及降解产物参考标准物在通过保留时间匹配研究鉴定药物大样本降解产物中的进一步应用。方法：在实验室中合成了降解产物的参考标准品，并通过光谱研究确定了它们的身份。使用HPLC研究将其用于保留匹配研究。色谱条件如下：固定相：Waters X Bridge C18色谱柱（250x4.6 mm，内径，粒径5μm），流动相：乙腈：75：25 v / v的水，柱箱温度：环境。在286 nm处以1 mL / min的流速监测色谱图。该方法已根据ICH指南进行了验证。结果：发现合成参考标准品的保留时间值与受压样品中那些降解产物的保留时间值相同。校准曲线在测试范围内显示出良好的线性回归（r2> 0.999）。该方法对样品中两种降解产物的定量均显示出良好的重现性和敏感性。方法精确，两种参考产品的回收率均在98-102％之内。结论：本通讯强调使用非参考标准品通过色谱方法对降解产物进行定量。建立了定量验证参数，如检测限和定量限。

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