Analytical method development and validation for simultaneous estimation of meropenem and vaborbactam in bulk and pharmaceutical dosage form by RP-HPLC
https://doi.org/10.54037/WJPS.2022.100309
Keywords:
Meropenem, Vaborbactam, Validation, Buffer and ICH GuidelinesAbstract
A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination Meropenem and Vaborbactam in pharmaceutical dosage form. The column used was KromosilC18(150mm x 4.6 mm, 5mm) in isocratic mode, with mobile phase containing phosphate buffer and acetonitrile (45:55v/v). The buffer is prepared by adding accurately weighed 1.36gm of Potassium dihyrogen Ortho phosphate in a 1000ml of Volumetric flask add about 900ml of milli-Q water added and degas to sonicate and finally make up the volume with water then pH adjusted to 5.0 with dil. Orthophosphoric acid solution. The flow rate was 1.0ml/ min and effluents were monitored at 260 nm. The retention times of Meropenem and Vaborbactam were found to be 2.299 min and 3.102 min, respectively. The linearity for Meropenem and Vaborbactam were in the range of 25-150µg/ml and 25-150 µg/ml respectively. Regression equation of Meropenem is y = 4826.x + 2593, and y = 4887.x + 6194 of Vaborbactam respectively. The proposed method was validated and successfully applied to the estimation of Meropenem and Vaborbactam in combined tablet dosage forms.
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Copyright (c) 2022 C. Parthiban, Aneesa, Chaithanya Dixit, B. Siddartha
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