Examination of Fourteen Elemental Impurities in Levofloxacin Parenteral by Applying ICP-MS Technique

Subject Areas : Journal of Chemical Health Risks

Gopikrishna Yenduri ¹ , Srinivasu Navuluri ²

1 - Division of Chemistry, Department of S & H, Vignan's Foundation for Science, Technology & Research (Deemed to be University), Vadlamudi, Andhra Pradesh, India – 522213
2 - Division of Chemistry, Department of S & H, Vignan's Foundation for Science, Technology & Research (Deemed to be University), Vadlamudi, Andhra Pradesh, India – 522213

Received: 2021-11-17 Accepted : 2023-02-12 Published : 2023-12-01

Keywords: Impurity, ICP-MS, Levofloxacin, Metal elements, Parenteral,

Abstract :

In our work, a process for levofloxacin (LVO) digestion using the microwave digester was proposed. Simultaneous examination of fourteen metal elemental impurities (lithium, vanadium, chromium, manganese, iron, cobalt, nickel, copper, arsenic, molybdenum, cadmium, antimony, mercury, and lead) in digested LVO sample was done by ICP-MS system. Quantification limits vary between 2.7 ppb to 3000 ppb for all studied metal elemental impurities. Linear regression analysis proved linearity from LOQ quantity level to 200% of respective metal specification quantity limitations. The slope and coefficient correlation findings for fourteen metal elemental impurities were reported to be within permissible limit values. These outcomes demonstrated that the recommended ICP-MS methodology is capable of detecting 14 metal elemental impurities. Percentage recoveries for all studied metal elemental impurities were revealed to be satisfactory with recommended ICP-MS methodology conditions. The fully validated ICP-MS technique was finally adopted for batch studies of six different LVO parenteral for the selected fourteen metal elemental impurities.

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