Development and Validation of a HPLC Method for Determination of Stability of Arsenoplatin Compounds in Saline Solution
Abstract
Arsenoplatins are potent dual pharmacophore anticancer agents that have shown efficacy in many cancers in vitro, with the most potency against breast, ovarian, and leukemia cancer cell lines. Therefore, there was a need to develop and validate a specific, rapid, and sensitive high-performance liquid chromatographic (HPLC) method for confirming the purity and stability of arsenoplatin compounds in saline for planned studies in vivo. Arsenoplatin compounds in saline were evaluated by an isocratic, reversed-phase method. A YMC C18 ODS-A analytical column (150 x 4.6mm, 3μm, 120Å) was used as the solid phase, and a deionized water-methanol-acetonitrile mixture (75:15:10) at a flow rate of 1.0 mL/min at 30°C as the mobile phase. The arsenoplatin compounds were detected at 284 nm using a multiple wavelength detector (MWD). A run time of 5 minutes was attained for each sample, signifying the analysis to be high throughput. The method was determined to be sensitive from the linear range of 50 μg/mL to 550 μg/mL (r2 ≥ 0.995). The method was specific by demonstrating the resolution of possible degradation compounds through acidic, alkaline, and oxidative stress conditions per ICH and FDA guidance.
Development and Validation of a HPLC Method for Determination of Stability of Arsenoplatin Compounds in Saline Solution
Arsenoplatins are potent dual pharmacophore anticancer agents that have shown efficacy in many cancers in vitro, with the most potency against breast, ovarian, and leukemia cancer cell lines. Therefore, there was a need to develop and validate a specific, rapid, and sensitive high-performance liquid chromatographic (HPLC) method for confirming the purity and stability of arsenoplatin compounds in saline for planned studies in vivo. Arsenoplatin compounds in saline were evaluated by an isocratic, reversed-phase method. A YMC C18 ODS-A analytical column (150 x 4.6mm, 3μm, 120Å) was used as the solid phase, and a deionized water-methanol-acetonitrile mixture (75:15:10) at a flow rate of 1.0 mL/min at 30°C as the mobile phase. The arsenoplatin compounds were detected at 284 nm using a multiple wavelength detector (MWD). A run time of 5 minutes was attained for each sample, signifying the analysis to be high throughput. The method was determined to be sensitive from the linear range of 50 μg/mL to 550 μg/mL (r2 ≥ 0.995). The method was specific by demonstrating the resolution of possible degradation compounds through acidic, alkaline, and oxidative stress conditions per ICH and FDA guidance.