Background:
Cefoperazone Sulbactam injection is a cephalosporin antibiotic with a β-
lactamase inhibitor used in the treatment for intra abdominal infections, Urinary track infections, surgical
infections, etc. The combination is not official in any of the pharmacopeia for their content and impurities
determination.
Introduction:
The present study involves the development of a simple, rapid, accurate, sensitive and
stability indicating RP-HPLC method for the quantitative estimation of Cefoperazone Sulbactam mixture
and its impurities in bulk and pharmaceutical dosage forms.
Methods:
0.005 M Tetrabutyl ammonium hydroxide buffer solution pH adjusted to 6.80 and Acetonitrile
combination has been used in a gradient programme with a flow rate of 1.0 ml/min. The retention
time of Cefoperazone and Sulbactam were observed at around 8.5 and 19.5 minutes respectively. The
UV detection was carried out at a wavelength of 230 nm. The chromatographic separation was achieved
using Waters xbridge C18-150*4.6 mm, 3.5 µm HPLC column. The method has been validated according
to the current International Council for Harmonization (ICH) guidelines for the method validation
parameters such as Specificity, linearity, range, accuracy, precision, robustness and sensitivity.
Results:
The validation results indicate that the method is specific, as the known impurities and other
impurities formed during the forced degradation studies were not co-eluting with the main components.
Moreover, all these impurities were found to be spectrally pure, proving the stability indicating power
of the method. The linearity and range of the method is in the range of 0.01-150%, highly accurate
(100.2%), precise (<1%) and robust.
Conclusion:
The proposed method was accurate and specific for the quantitative analysis of Cefoperazone
and Sulbactam and their related impurities in the sterile mixture. Hence the proposed method can
be used for the quantification of impurities in routine as well as stability analysis in the development as
well as quality control laboratories.
Miniaturized Forced Degradation of Therapeutic Proteins and ADCs by Agitation-Induced Aggregation using Orbital Shaking of Microplates
