Development and Validation of a Sensitive RP-HPLC Method for Quantifying Oxaliplatin in ZIF-8 as a Drug Delivery System

Abstract

Introduction: Oxaliplatin is widely utilized in cancer therapy but is often limited by significant side effects. Zeolitic Imidazolate Framework-8 (ZIF-8), a type of metal-organic framework nanoparticle, has been investigated as a delivery system for oxaliplatin, offering advantages such as targeted cancer cell delivery and controlled drug release. This study aimed to develop and validate a sensitive, straightforward, and cost-effective reverse-phase high-performance liquid chromatography (RP-HPLC) method for quantifying oxaliplatin within ZIF-8.

Methods: Various chromatographic conditions were optimized to accurately quantify oxaliplatin-loaded ZIF-8. The final HPLC method was validated in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.

Results: Chromatographic separation was achieved on an RP-C18 column (250 x 4.6 mm, 5 µm) using isocratic elution with a methanol-water mobile phase (1:1 ratio) at a flow rate of 0.8 mL/min. Detection was performed with a PDA detector set at 230 nm. The method demonstrated suitability through validation of specificity, linearity, accuracy, precision, range, and robustness. Linearity was confirmed within a concentration range of 0.1-1.5 mg/mL, with a correlation coefficient (R²) of 0.9994. Accuracy ranged from 98.79% to 99.71%, with a mean accuracy of 99.16%, and the relative standard deviation was 0.48%.

Conclusion: The validated RP-HPLC method offers a reliable and robust means for assessing the loading capacity and release performance of oxaliplatin in ZIF-8, serving as an essential analytical tool for evaluating this drug delivery system. This approach supports precise formulation assessment, aiding in the accelerated development of future applications in drug delivery research.