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首页> 外文期刊>American Journal of Chemical Engineering >Development and Validation for RP-HPLC Method of Assay of Omeprazole Capsules Formulation
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Development and Validation for RP-HPLC Method of Assay of Omeprazole Capsules Formulation

机译：奥美拉唑胶囊制剂测定的RP-HPLC方法开发与验证

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摘要

Omeprazole is a potent proton pump inhibitor for the treatment of various acid-related gastrointestinal disorders. simple, selective and rapid reversed phase high performance liquid chromatographic (RP-HPLC) method for the analysis of Omeprazole has been developed and validated. The separation was achieved from HPLC column (ZORBAX, XDB, C-18 (150×4.6 mm, 5 micron) with a mobile phase consisting of HPLC grade acetonitrile and phosphate buffer solution (pH 7.4) in the ratio of (60:40 v/v) at a flow rate of 0.5 ml/min and runtime 10 min with UV detector at 302nm. The method was specific and it was observed that no interference with diluents. The proposed method was accurate with 100.95% recovery omeprazole and precise (% RSD of area of system precision, % RSD of assay of method precision were found to be 0.14% and 0.37% respectively). From the linearity study the correlation coefficient is found to be 0.9988, which indicated that the method was linear over 25% to 175% range. The method was found robust for possible changes. Therefore, this method can be used as a more convenient and efficient option for the analysis of Omeprazole to establish the quality of the drug substance during routine analysis with consistent and reproducible results.
机译：奥美拉唑是一种有效的质子泵抑制剂，可用于治疗各种与酸有关的胃肠道疾病。已开发并验证了用于奥美拉唑分析的简单，选择性和快速反相高效液相色谱（RP-HPLC）方法。从HPLC柱（ZORBAX，XDB，C-18（150×4.6 mm，5微米））进行分离，流动相由HPLC级乙腈和磷酸盐缓冲液（pH 7.4）组成，比例为（60:40 v / v），流速为0.5 ml / min，使用302nm紫外检测器运行10分钟，该方法具有特异性，观察到对稀释剂没有干扰。该方法准确度高达100.95％，回收了奥美拉唑，精确度（％系统精密度面积的RSD，方法精密度测定的％RSD分别为0.14％和0.37％。根据线性研究，相关系数为0.9988，表明该方法在25％到50％线性。在175％范围内发现该方法对可能的变化是健壮的，因此，该方法可作为奥美拉唑分析的一种更方便，更有效的选择，以在常规分析过程中确定原料药的质量，并获得一致且可重复的结果。

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