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首页> 外文期刊>Analytical methods >Stability-indicating HPLC-DAD method for the simultaneous determination of fluoroquinolones and corticosteroids in ophthalmic formulations
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Stability-indicating HPLC-DAD method for the simultaneous determination of fluoroquinolones and corticosteroids in ophthalmic formulations

机译:指示性HPLC-DAD法同时测定眼科制剂中的氟喹诺酮类和皮质类固醇

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摘要

The aim of this study is to develop and validate a stability-indicating assay method for simultaneous determination of gatifloxacin and prednisolone acetate, or of ciprofloxacin hydrochloride and dexamethasone in combination and in the presence of degradation products. Reverse-phase high-performance liquid chromatography is used. All analyses were carried out on a Kinetex C18 column and acetronitrile-water (50 : 50 v/v) pH 3.0 mobile phase with 0.30 mL min~(-1) flow rate. Efficient chromatographic separation of these drugs and their forced degradation products is achieved in less than 6 min and with a peak purity match factor higher than 950. The method shows linearity in the concentration range of 1.2 to 9.6 μg mL~(-1) for gatifloxacin (r = 0.9995), 2.0 to 16.0 μg mL~(-1) for prednisolone acetate (r = 0.9997), 2.5 to 25.0 μg mL~(-1) for both ciprofloxacin hydrochloride (r = 0.9993) and dexamethasone (r = 0.9998), precision (relative standard deviation lower than 2%), accuracy (mean recovery 100 ± 2%), and robustness, according to ICH and AOAC guidelines. This method is able to determine simultaneous ophthalmic combinations of these drugs and to separate the drug peaks from their forced degradation products. Additionally, the optimized chromatographic conditions can contribute to minimize waste of organic solvent.
机译:这项研究的目的是开发并验证一种稳定性指示测定方法,该方法可同时测定加替沙星和醋酸泼尼松龙,或联合使用环丙沙星盐酸盐和地塞米松,并同时测定降解产物的存在。使用反相高效液相色谱。所有分析均在Kinetex C18色谱柱和乙腈-水(50:50 v / v)pH 3.0流动相中进行,流速为0.30 mL min〜(-1)。这些药物及其强制降解​​产物的有效色谱分离可在不到6分钟的时间内完成,并且峰纯度匹配因子高于950。该方法在加替沙星的浓度范围为1.2至9.6μgmL〜(-1)时呈线性关系。 (r = 0.9995),醋酸泼尼松龙(r = 0.9997)2.0至16.0μgmL〜(-1),盐酸环丙沙​​星(r = 0.9993)和地塞米松(r = 0.9998)均为2.5至25.0μgmL〜(-1) ),精度(相对标准偏差低于2%),精度(平均回收率100±2%)和鲁棒性(根据ICH和AOAC指南)。该方法能够确定这些药物的同时眼科组合,并将药物峰与它们的强制降解产物分开。此外,优化的色谱条件可以最大程度地减少有机溶剂的浪费。

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