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Application of Green Chemistry for the Simultaneous Determination of Ceftriaxone Sodium in its Binary Mixture with Sulbactam Sodium in Human Plasma and dosage forms

Abstract Green chemistry aims to develop earth-friendly chemical processes and products that will prevent or minimize pollution and hazardous substances. In this work, the green chemistry was applied for the simultaneous determination of ceftriaxone sodium (CX) and sulbactam sodium (SL) via a sensitive, accurate, and precise high-performance liquid chromatography (HPLC) method. The method is applied for the simultaneous determination of the two drugs in the presence of ceftizoxime (active metabolite of ceftriaxone) in human plasma using cefotaxime as internal standard (IS). The analytes and the internal standard were separated using a mobile phase consisting of 0.005 M potassium dihydrogen phosphate buffer (pH 4.6) – ethanol (92: 8, v/v) and detected at 220 nm. Analytes and internal standard were extracted from plasma by simple precipitation technique using methanol. The method also determined both drugs simultaneously in the presence of their acidic, alkaline, oxidative, neutral, and photolytic degradation products, in pure form and pharmaceutical dosage forms using the same chromatographic conditions. The stability of the drugs in plasma was confirmed during 6 hours at room temperature, two weeks at freezer (-20°C), and three freeze-thaw cycles (-20°C). The method can be applied for pharmacokinetic studies.