Quantification of oxaliplatin- and ioversol-related compounds in pharmaceutical formulations using novel HPLC-ICP-MS methods

• Published in: Journal of pharmaceutical and biomedical analysis 2024-05, Vol.242, p.116026-116026, Article 116026
• Main Authors: Wu, Qiping, Lv, Jianmei, Xie, Feifan, Li, Sanwang
• Format: Article
• Language: English
• Subjects: HPLC; ICP-MS; Quantitative analysis; Related compounds
• ISSN: 0731-7085; 1873-264X
• DOI: 10.1016/j.jpba.2024.116026

Accurate quantifying of drug-related compounds in medicines is vital for safety. Commonly used structure-dependent methods rely on analytical standards. High-performance liquid chromatography coupled with inductively coupled plasma-mass spectrometry (HPLC-ICP-MS) offers a promising solution, being structure-independent and not requiring standards. In this study, we aim to develop HPLC-ICP-MS methods for the determination of related compounds in oxaliplatin and ioversol injections. The target analytes were eluted on an XSelect HSS T3 column (2.1 ×50 mm, 5 µm). Specifically, oxaliplatin injection was eluted isocracially for 3.5 min, and ioversol injection was eluted gradient with a total chromatographic run time of 12 min. The measurements to determine dihydroxy oxaliplatin-Pt(IV) and two related compounds of ioversol were performed by monitoring at m/z for 195Pt and 127I, respectively. The calibration curves were established over the range of 0.05–1 μM for Pt and 0.3–15 μM for I with the correlation coefficients greater than 0.999. The limits of quantification were 0.004 μM for dihydroxy oxaliplatin-Pt(IV), 0.022 μM for ioversol related compound A and 0.026 μM for ioversol related compound B. The accuracy (recovery between 93–105%) and precision (repeatability ≤ 6.1% RSD) were fit-for-purpose for dihydroxy oxaliplatin-Pt(IV), and the accuracy (recovery between 95–107%) and precision (repeatability ≤ 3.9% RSD) were also fit-for-purpose for both ioversol related compound A and ioversol related compound B. The quantitation accuracy of HPLC-ICP-MS closely matched that of the standard HPLC-UV approach. HPLC-ICP-MS can be used as a complementary analytical technique for quantitative determination of drug-related compounds. [Display omitted] •Direct quantification of oxaliplatin- and ioversol-related compounds via HPLC-ICP-MS without the need for reference standards.•The established HPLC-ICP-MS methods are validated according to the ICH Q2(R1) guidelines.•Excellent quantitative consistency observed between the novel HPLC-ICP-MS methods and the standard HPLC-UV methods.