Abstract

DETERMINATION OF MEROPENEM AND VABORBACTAM IN DRUG SUBSTANCE AND DRUG PRODUCT DOSAGE FORMS – A VALIDATED CHROMATOGRAPHIC METHOD BY RP-UPLC USING ANALYTICAL QBD PRINCIPLES.

Vishnu Priya M.*, P. Madhavan, Pramod Kumar and Manoj Kumar Metta

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Abstract

A parenteral drug product containing Meropenem and Vaborbactam is an antibacterial drug mainly to treat complicated urinary tract infection (cUTI). A RP-UPLC method was developed and validated per ICH (Q2) R1 for determining the identity and assay for its drug substance and drug product. The validation was performed on waters system equipped with the HSS C18 column, 0.1% Ortho phosphoric buffer: Acetonitrile (60: 40 v/v) as a mobile phase with a flow rate of 0.3 ml/min and λ max of 260 nm. The calibration plot was linear over the range of 25-150 μg/ml, LOD, LOQ were about 0.6 and 2.0 μg. The Accuracy by recovery was about 99%. The repeatability, robustness and solutions stability studies showed that the method is precise. Quality by design (ICH Q8- R1) requires a prospective summary of the desired quality characteristics of a drug substance and drug product. This is known as Quality Target Product Profile (QTPP), which forms the basis for the design and development of the method. Design space of the experiment was implemented to verify the robustness of the method using DOE.

Keywords: Antibacterial; Method validation; ICH (Q2) R1; UPLC; Analytical Quality by Design (AQbD).