Development of HPLC Approach for Anticancer Drugs Combination Assay: Determination of Stability Indicating Quality and Stabilities of Anticancer Drugs Studied under the ICH Outlined Degrading Conditions

The combined use of tegafur (TAR), gimeracil (GAR), and oteracil (OAR) is often employed for the therapy of malignant tumors. A high-performance liquid chromatography (HPLC) approach was developed to consistently and precisely measure GAR, OAR, and TAR in a combined pharmaceutical formula that uses a shorter operation time. The separation followed by assessment of GAR, OAR and TAR is done with C18 (Waters, USA) column (250; 4.6 mm; temperature 25˚C) and the mobile phase ratio used included 60% vol (0.1 M NaHSO4): 40% vol (methanol). Upon applying stress conditions, International Council for Harmonisation (ICH) recommended to GAR, OAR and TAR. The HPLC findings pointed out the nonexistence of any interference between the drugs under test and the degradation compounds. The stability indicating quality was established by the peak purity results for GAR, OAR, and TAR, which disclose that the test peaks (GAR, OAR, and TAR) were homogenous in all stress settings examined. From stability studies, we found that GAR showed significant degradation when rendered to dry heat, while TAR and OAR exhibited significant degradation after being exposed to acidic conditions. The suggested approach could potentially be implemented to assess the stability of GAR, OAR, and TAR under stress environments as well as to perform quality control checks on the three mentioned drugs in capsule doses.