Stability-indicating high-performance liquid chromatographic method for the simultaneous determination of cisplatin and 5-fluorouracil in 0.9% sodium chloride for injection.

The serendipitous discovery by Rosenberg et al. [ 1 ] that cell replication could be inhibited by platinum complexes led to the development and therapeutic use of cisplatin (cis-diamminedichloroplatinum II) as an anticancer agent. Cisplatin is currently used in treating testicular, ovarian, and lung cancers as well as squamous cancers of the head and neck [ 2-51. The anticancer agent 5fluorouracil (5-FU) is currently used in treating several malignancies including cancers of the lung, head and neck, and colon [ 3,4]. Cisplatin and 5-FU are often given in combination to treat a variety of malignancies [5,6]. The admixture of more than one anticancer drug in a single intravenous solution is both cost-effective and advantageous to the patient. Combinations of drugs admixed in the same intravenous fluid can result in the precipitation or loss of potency of one or both drugs. Since questions often arise concerning the compatibility of cisplatin and 5-FU in the same intravenous admixture, a study of the stability and compatibility of the combination of cisplatin and 5-FU in 0.9% (w/v) sodium chloride solution was designed. Loss of potency of one or more of the drugs in the intravenous admixture may occur without obvious visual changes. Therefore, a rapid, simple, and pre-