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International Journal of Zoology and Applied Biosciences Research Article
Simultaneous estimation of imipenem, cilastatin, and relebactum in pharmaceutical lyophilized powder for injection by applying stability indicating LC-PDA method
Gollu Gowri, Madhavi karimajji, Lekhya Gurijala, Polipalli Venkata Navya, Sivanaga Tejaswini Naredla
Year : 2025 | Pages: 332-339
Received on: 09/09/2025
Revised on: 27/10/2025
Accepted on: 13/11/2025
Published on: 30/11/2025
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Gollu Gowri, Madhavi karimajji, Lekhya Gurijala, Polipalli Venkata Navya, Sivanaga Tejaswini Naredla( 2025).
Simultaneous estimation of imipenem, cilastatin, and relebactum in pharmaceutical lyophilized powder for injection by applying stability indicating LC-PDA method
. International Journal of Zoology and Applied Biosciences, 10( 6), 332-339.
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Abstract
Triple combination of Imipenem, Cilastatin and Relebactam (RECARBRIO) was FDA approved in 2019 to treat various bacterial infections. For the simultaneous estimation of Imipenem, Cilastatin, and Relebactum in pharmaceutical dose form, an accurate and precise method was established. The chromatographic separation was performed using a BDS C18 column (150x4.6mm, 5mm). At 1.0 ml/min flow rate and 248 nm detection wavelength,mobile phase containing 0.1% orthophosphoric acid and acetonitrile(60:40, v/v) was passed down the column over the run time of 4.5 min. 30°C was kept as the temperature.Cilastatin and Relebactum eluted with retention times of 2.328, 3.092, and 3.625 min., respectively. Linearity was observed with the concentration range of 12.5-75 µg/mL, 12.5-75 µg/mL and 6.25-37.5 µg/mL for, cilastatin the imipenem and relebactum respectively. The %RSD of method precision were determined to be 1.0, 1.2, and 0.5, respectively and %RSD of intermediate precision that was determined to be, respectively, 1.3, 0.7, and 1.1. Imipenem, Cilastatin, and Relebactum, respectively, showed 99.87%, 99.78%, and 99.84% recovery rates. Stability indicating nature of the method was assessed by conducting forced degradation studies and the percentage degradation of respective analytes were reported. Comparatively retention times of all respective analytes have reduced and all the three respective analytes eluted within 4 min., resulted in a simple and affordable method that can be used in routine quality control tests in pharmaceutical industries.
Keywords
Imipenem, Cilastatin, Relebactum, RP-HPLC, Forced degradation, ICH guideline.
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© The Author(s) 2025. This article is published by International Journal of Zoology and Applied Biosciences under the terms of the Creative Commons Attribution 4.0 International License (creativecommons.org), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
