Development and Validation of an RP-UFLC Method for the Estimation of Oxaliplatin Drug for the Preparation of Oxaliplatin Nanoparticles

Abstract

Background: Oxaliplatin, a platinum-based antineoplastic agent, is widely used to treat colorectal cancer. It is well-known for its capacity to hinder the development and division of cells, especially fast-dividing ones, like cancer cells, via the creation of DNA adduct. The currently published oxaliplatin analytical methods require a complex, difficult-to-understand procedure, and are costly. Objective: The main objectives of our study were to select the chromatographic parameters, develop a UFLC method and validate it, and validate the results according to ICH guidelines. Method: In this UFLC study, a normal phase C18 column (250cm x 4.6 mm x5 μm) with a mobile phase containing 0.01 M orthophosphoric acid and acetonitrile (95:5 V/V) has been used at pH 3.5. Flowrate has been fixed at 1ml/min and the sample has been tested in the UV range for detection. The methods have been validated for precision, linearity, forced degradation studies, robustness, and accuracy. Results: The retention time of the drug has been found to be >8min. The calibration curve of the drug has been obtained within the range of 10–240 μg/ml. The results of this analysis have been validated according to ICH guideline Q2 (R1) for registration of human use. Conclusion: The UFLC method we have used for oxaliplatin quantification has been found to be simpler, easier to understand, and more cost-effective than standard HPLC as it has consumed less mobile phase and less time. Thus, we can conclude that this new, simple, and easy method may be a useful alternative to the existing standard methods for oxaliplatin.