A simple, rapid, sensitive, specific, eco-friendly and stability-indicating linear gradient liquid chromatographic method (RP-UHPLC) for simultaneous estimation of assay and its related compounds in Meropenem API samples is developed and validated. Chromatographic separation was achieved on Zorbax Eclipse plus C18, (100 x 4.6) mm, 3.5 µm RRLC short column and 10 mM potassium dihydrogen orthophosphate is used as buffer, buffer solution used as eluent A and buffer and acetonitrile combination 30: 70 v/v ratio used as eluent B and Agilent RRLC (UHPLC) system is used for analysis. The mobile phase flow rate was 1.0 ml/min, and the eluted compounds have been monitored at 220 nm for related substance method and 290 nm for assay method. Excellent resolution is obtained between Meropenem and its related compounds which were eluted within 10 min. The correlation co-efficient(r) is > 0.995 for both the methods from linearity data and percentage of recovery is 98.0 to 102.0 and 80.0 to 120.0 % for assay method and for related substance method, respectively. Sensitivity of the method is found to be less than 0.316 µg/ml. Peak homogeneity data for Meropenem in the chromatograms from the stressed samples are obtained by using photodiode array detector demonstrated the specificity of the method for analysis of Meropenem in presence of the degradation compounds. The performance of the method is validated according to the present ICH guidelines for specificity, limit of detection, limit of quantification, linearity, accuracy, precision, and robustness.

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经验证的新颖环保的RP-UHPLC方法用于美洛培南的测定及相关物质

开发并验证了一种简单，快速，灵敏，特异，生态友好且具有稳定性的线性梯度液相色谱方法（RP-UHPLC），用于同时估算美罗培南API样品中的测定及其相关化合物。在Zorbax Eclipse plus C18（100 x 4.6）mm，3.5 µm RRLC短柱上进行色谱分离，并使用10 mM正磷酸二氢钾作为缓冲液，将缓冲溶液用作洗脱液A，并将缓冲液和乙腈组合使用30：70 v / v比率B作为洗脱液B，使用Agilent RRLC（UHPLC）系统进行分析。流动相流速为1.0 ml / min，洗脱的化合物已在220 nm下进行相关物质方法监测，在290 nm下进行测定方法监测。美洛培南及其相关化合物在10分钟内洗脱后获得了极好的分离度。对于来自线性数据的两种方法，相关系数（r）均均大于0.995，对于测定法和相关物质方法，回收率分别为98.0％至102.0％和80.0％至120.0％。发现该方法的灵敏度小于0.316 µg / ml。通过使用光电二极管阵列检测器获得的应力样品色谱图中美洛培南的峰均一性数据证明了在降解化合物存在下分析美洛培南的方法的特异性。该方法的性能根据当前的ICH指南针对特异性，检测限，定量限，线性，准确性，精密度和鲁棒性进行了验证。