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首页> 外文期刊>Indian Journal of Pharmaceutical Education & Research >Applications of New Validated RP-HPLC Method for Determination of Indomethacin and its Hydrolytic Degradants using Sodium Acetate Buffer
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Applications of New Validated RP-HPLC Method for Determination of Indomethacin and its Hydrolytic Degradants using Sodium Acetate Buffer

机译：新验证的RP-HPLC方法应用醋酸钠缓冲液测定吲哚美辛及其水解降解剂的应用

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摘要

Objective: A New RP-HPLC method for estimation of indomethacin and its two degradant impurities 4-chlorobenzoic acid, 5-methoxy-2-methyl-indoleacetic acid was developed and validated as per ICH guidelines. Background: This new method is not only capable of identifying and quantifying the impurities but also can be used for the assay of indomethacin in marketed capsule formulations. Methods: The chromatographic conditions were optimized using Zorbax Eclipse Plus C18, 3.5 mu m (4.6 mm x 100 mm) column with methanol: acetonitrile: 10 mM sodium acetate buffer pH 3, 10: 50: 40% v/v as the mobile phase at the flow rate of 1 ml/min and detection was carried out using UV-Visible PDA detector at 254 nm. Results: The method was linear over concentration range of 25-70 mu g/ml for indomethacin, 0.25-2 mu g/ml for 4-chlorobenzoic acid and 0.252 mu g/ml for 5-methoxy-2-methyl-indoleacetic acid. The developed method was validated as per the ICH guidelines for linearity, accuracy, precision, limit of detection, limit of quantification, robustness and specificity for indomethacin and its impurities.
机译：目的：新的RP-HPLC估计吲哚美辛及其两种降解杂质4-氯苯甲酸，5-甲氧基-2-甲基 - 吲哚酸，根据ICH指南验证。背景：这种新方法不仅能够识别和量化杂质，而且可以用于吲哚美辛在市场上的胶囊配方中的测定。方法：采用氧化乙酸eClipse加上C18，3.5μm（4.6mm×100mm）柱优化色谱条件：乙腈：乙腈：10mM乙酸钠缓冲液pH 3,10：50：40％V / V作为流动相在1mL / min的流速下，使用UV可见PDA检测器在254nm处进行检测。结果：该方法在浓度范围内为25-70μmg/ ml的吲哚美辛，4-氯苯甲酸0.25-2μg/ ml，对于5-甲氧基-2-甲基 - 吲哚乙酸0.252μg/ ml。根据ICH的线性，准确性，精度，检测极限，定量限制，吲哚美辛的定量限制及其杂质，验证开发的方法及其杂质。

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