Abstract
A rapid and accurate high performance liquid chromatography (HPLC) method is described for simultaneous determination of piperacillin sodium and sulbactam sodium in sterile powder for injection. Chromatographic separation of the two drugs was achieved on a Diamonsil C18 column (150 × 4.6 mm, 5 µm) using a mobile phase consisting of a mixture of methanol and 0.01 M tetrabutylammonium hydroxide (TBAH) (50:50, v/v). The flow rate was 1.0 mL/min and detection was made at 220 nm. Salicylic acid was used as internal standard. Separation was completed in less than 15 min. The method was validated for system suitability, linearity, accuracy, precision, limit of quantitation, and robustness. The linear range for piperacillin sodium and sulbactam sodium was 103.0–1030.0 µg/mL and 24.0–240.0 µg/mL, respectively. Limit of quantitation (LOQ) was 22.05 µg/mL for piperacillin sodium and 5.48 µg/mL for sulbactam sodium. Relative standard deviation (RSD), for piperacillin sodium and sulbactam sodium was less than 1.0 and 1.2%, respectively.
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