Reverse Phase High-Performance Liquid Chromatography Method Development and Estimation of Sulbactam and Durlobactam 1 g of Injection in Parenteral Dosage Form and Bulk

Abstract

Aims: A straightforward, stability-indicating, and reliable reverse-phase high-performance liquid chromatography
(HPLC) technique has been validated and created for the concurrent estimation of sulbactam and durlobactam in both
pharmaceutical and bulk dosage forms, including degradation studies, which are forced. Materials and Methods: The
immobile phase utilized for separation is a SunFire C18 HPLC column with a particle size of 5 μm, measuring L ×
I.D. 250 mm × 4.6 mm. Mobile phase consists of methanol and 0.01N KH2
PO4
in a 70:30 ratio, maintained at a rate
of flow of 1 mL/min, with a maximum wavelength set at 248 nm. The temperature was established at 30°C. The
average retention time (R.T.) for sulbactam and durlobactam was recorded as 3.552 and 2.483 min, respectively.
Results: The relative standard deviation values for sulbactam and durlobactam were determined to be 0.3 and 0.6,
respectively. Recovery rates were achieved at 99.85% for sulbactam and 100.31% for durlobactam. The limit of
detection and limit of quantification values derived from the regression equations for sulbactam and durlobactam
were 0.41, 1.24 and 0.46, 1.39, respectively. The regression equation for sulbactam is expressed as y = 16378x +
8015.2, whereas for durlobactam, it is also y = 16364x + 7769.9. Both recovery tests and statistical validation of the
approach were carried out. The mentioned compounds, whether in pure form or in pharmaceutical formulations, have
been successfully analyzed using the recommended approach with good accuracy and precision. This technique can
be applied to pharmaceutical compositions for routine medication analysis and quality monitoring. Conclusion:
Precision, Accuracy, LOD, LOQ & Robustness were among the validation metrics & found to be acceptable limits.
The recovery percentage for Sulbactam and Durlobactam were found to be 99.93% & 99.91%.