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L Kalyani1 and Chava Venkata N Rao2*
1Department of Chemistry, NRI Institute of Technology, Perecherla, Guntur, Andhra Pradesh
2Department of Chemistry, NRI Institute of Technology, Pothavarappadu, Andhra Pradesh
A B S T R A C T
A simple, accurate, rapid, and stability-indicating RP-HPLC method for a combination of Sulbactam and Ceftazidime has been developed and subsequently validated in commercial formulation vials. The proposed HPLC method utilizes Waters C-18 (250mm x 4.6mm, 5μm) column and mobile phase consisting of Water, Methanol and Acetate Buffer 50:30:10 (v/v) with flow rate of 1.0 ml/min. Quantization was achieved with UV detection at 236 nm. The method is validated in terms of accuracy, precision, linearity, limits of detection, limits of quantization, and robustness. This optimized method has been successively applied to pharmaceutical formulation. Sulbactam and Ceftazidime combination drug product were subjected to acid, base, neutral hydrolysis, oxidation, dry heat, and photolytic stress conditions and the stressed samples were analyzed by the proposed method. As the proposed LC method could effectively separate the drugs from its degradation products, it can be employed as stability-indicating method for the determination of instability of these drugs in bulk and commercial formulations.
Keywords: Ceftazidime (CFZ), Sulbactam (SBT), RP-HPLC, Validation, Forced Degradation
