Validation of Effective β-Lactum Antibiotics in Available Dosage Forms by RP-HPLC Developed Analytical Chromatographic Method

Abstract

Background: Vaborbactam and Meropenem are co-formulated in pharmaceutical tablets for enhanced antibacterial activity. A simple, economical, and reliable analytical method is required for their simultaneous quantification. Materials and Methods: A simultaneous HPLC method was developed and validated using a 996 PDA detector. Separation was achieved on a Phenomenex Gemini C18 column (150 × 4.6 mm, 5.0 µm) with an isocratic mobile phase consisting of methanol and triethylamine buffer (pH 4.8) in a 32:68 v/v ratio. The flow rate was 1 mL/min, and detection was performed at 260 nm. Calibration curves were constructed for both drugs over the 20-100 µg/mL concentration range. Method validation followed ICH guidelines. Results: Meropenem and Vaborbactam showed excellent linearity within the selected ranges, with recovery values of 99.92-100.36% and 100.56-100.74%, respectively. Precision studies demonstrated good repeatability with %RSD < 1% for both drugs. The LOD was 2.6 µg/mL for Meropenem and 3.4 µg/mL for Vaborbactam, while the LOQ was 7.8 µg/mL and 10.4 µg/mL, respectively. The method successfully quantified both active components in commercial tablet formulations. Conclusion: A simple, economical, and accurate HPLC method was developed and validated for the simultaneous determination of Vaborbactam and Meropenem in tablet dosage forms. The method meets ICH requirements and is suitable for routine quality-control analysis.