Drug Development and Validation of Elemental Impurities Content in Methotrexate Injection USP 250 mg/10 ml by Inductively Coupled Plasma Mass Spectroscopy (ICP-MS)
Author(s): Smruti Ranjan Mohanty* and Susanta Kumar Panda
Abstract
Background and objectives: Validation of elemental Impurities Content in Methotrexate injection USP 250 mg/10 mL.
Methods: This was achieved by using internal standard method with Inductively Coupled Plasma Mass Spectroscopy in KED mode with diluent concentration nitric acid and Hydrochloric Acid.
Results: System meets the system suitability criteria as specified in USP method of analysis. % Recovery for each analyte was found within the specified limit 70.0–150.0 for 100% level.
Conclusion: The system suitability and sample % recovery found within the range of 70% to 150% and this method is used for validation of Methotrexate Injection USP
