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首页> 外文期刊>Journal of liquid chromatography and related technologies >Simultaneous determination of omeprazole and domperidone in capsules and in vitro dissolution studies by using stability indicating UPLC
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Simultaneous determination of omeprazole and domperidone in capsules and in vitro dissolution studies by using stability indicating UPLC

机译：使用稳定性指示剂UPLC同时测定胶囊中的奥美拉唑和多潘立酮以及体外溶出度研究

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摘要

A novel stability indicating UPLC method was developed and validated for the simultaneous determination of omeprazole and domperidone in capsules formulation. The analysis was performed on a waters Acquity UPLC system with an Acquity UPLC BEH C18 column (5mm×2.1mm I.D., 1.7m). Isocratic elution with a mobile phase consisting of a mixture of phosphate buffer (pH 5.0, 0.05M) and Acetonitrile in the ratio of 68:32 (v/v). The flow rate was 0.4mL/min and the column temperature maitained at 50C. The eluted compounds were monitored at 285nm. Total run time was 2min within which the two compounds were well-seperated. Stability indicating capability was established by forced degradation experiments and seperation of known impurities from the two compounds. The method was validated for accuracy, precision, specificity, and linearity and hence the method was concluded to be stability indicating. The method is also applicable for analysis of Assay and also for study of in vitro dissolution profiles.
机译：开发了一种新的稳定性指示UPLC方法，并验证了该方法可同时测定胶囊制剂中的奥美拉唑和多潘立酮。该分析是在带有Acquity UPLC BEH C18色谱柱（内径5mm x 2.1mm，1.7m）的Waters Acquity UPLC系统上进行的。用流动相进行等度洗脱，该流动相由比例为68:32（v / v）的磷酸盐缓冲液（pH 5.0、0.05M）和乙腈的混合物组成。流速为0.4mL / min，柱温保持在50℃。在285nm处监测洗脱的化合物。总运行时间为2分钟，在此期间两种化合物被很好地分开。通过强制降解实验和从两种化合物中分离出已知杂质来建立稳定性指示能力。该方法的准确性，精密度，特异性和线性经过验证，因此该方法被认为是稳定性指示。该方法还适用于分析分析以及研究体外溶出曲线。

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