反相高效液相色谱法同时测定原料药和制剂中美罗培南和瓦波巴坦含量的分析方法建立与验证

C. Parthiban, Aneesa, Chaithanya Dixit, B. Siddartha
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引用次数: 1

摘要

建立了一种简便、特异、准确的反相高效液相色谱法同时测定美罗培尼和维博巴他明制剂剂型的方法。色谱柱为KromosilC18(150mm × 4.6 mm, 5m),等压柱,流动相为磷酸缓冲液和乙腈(45:55v/v)。缓冲液的制备方法为:在1000ml的容量瓶中加入精确称量的1.36gm磷酸二氢钾,加入约900ml的ml - q水,然后脱气超声,最后用水补齐体积,用dil调节pH至5.0。正磷酸溶液。流速1.0ml/ min,在260nm处监测流出物。美罗培曼和万博巴坦的滞留时间分别为2.299 min和3.102 min。美罗培曼和瓦布巴坦的线性范围分别为25 ~ 150μg/ml和25 ~ 150μg/ml。美罗培南的回归方程为y = 4826。X + 2593和y = 4887。vaborbactamx + 6194。该方法经验证,成功地应用于美罗培尼和维博巴他明联合片剂剂型的评价。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Analytical method development and validation for simultaneous estimation of meropenem and vaborbactam in bulk and pharmaceutical dosage form by RP-HPLC
A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination Meropenemand Vaborbactaminpharmaceutical dosage form. The column used was KromosilC18(150mm x 4.6 mm, 5m)in isocratic mode, with mobile phase containing phosphatebufferandacetonitrile (45:55v/v). The buffer is prepared by adding accurately weighed 1.36gm of PotassiumdihyrogenOrtho phosphate in a 1000ml of Volumetric flask add about 900ml of milli-Q water added and degasto sonicate and finally make up the volume with water then pH adjusted to 5.0with dil. Orthophosphoric acid solution. The flow rate was 1.0ml/ min and effluents were monitored at 260nm. The retention times of Meropenemand Vaborbactamwere found to be 2.299 min and 3.102 min, respectively. The linearity for Meropenemand Vaborbactamwere in the range of 25-150μg/mland 25-150 μg/ml respectively. Regression equation of Meropenem is y = 4826.x + 2593, and y = 4887.x + 6194 of Vaborbactamrespectively. The proposed method was validated and successfully applied to the estimation of Meropenemand Vaborbactamin combined tablet dosage forms.
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