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


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

image 10.4303/JDAR/236210

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