Development and validation of a stability indicating RP HPLC method for simultaneous estimation of Sulbactam–Durlobactam with multi metric sustainability assessment

The current study aimed to develop and validate a stability-indicating RP-HPLC method for the simultaneous determination of Sulbactam and Durlobactam. Separation of Sulbactam and Durlobactam was achieved by an Agilent C18 column using isocratic elution with 0.01 M disodium hydrogen phosphate buffer and acetonitrile (70:30, v/v) at a flow rate of 1.0 mL/min. and a detection wavelength of 220 nm. The method was validated in accordance with ICH Q2R1 guidelines and performed forced degradation studies. An analytical metric tool, such as AGREE, MoGAPI, or the Analytical Eco-Scale, is used to assess the method’s greenness. The blue applicability grade index and the red analytical performance index were used to evaluate the method’s practicality and performance. Multi-model assessment and white analytical chemistry were used to comprehensive assessment of the developed method. The retention times attained at 2.17 min for Sulbactam and 2.84 min for Durlobactam within a total run time of 5 min. Linearity was established over concentration ranges of 25–150 µg/mL for Sulbactam and 12.5–75 µg/mL for Durlobactam. The limits of detection and quantification were 0.31 and 0.94 µg/mL for Sulbactam, and 0.11 and 0.33 µg/mL for Durlobactam, respectively. Forced degradation studies were performed to assess the method’s stability-indicating capability. The scores from AGREE (0.72), MoGAPI (78), and Analytical Eco Scale (79) confirmed the method as eco-friendly. The scores of 80 and 82.50 for the blue applicability grade index and the red analytical performance index ensure the practicality and performance of the method. The proposed method is simple, reliable, robust, and sustainable for the simultaneous estimation of Sulbactam and Durlobactam.