Drug Development and Verification of Elemental Impurities Content in Cyclosporin Injection USP 250 mg/5 ml by Inductively Coupled Plasma Mass Spectroscopy (ICP-MS)
Objectives: Development and verification of elemental Impurities Content in Cyclosporin Injection USP 250 mg/5 mL.
Material and method: This was achieved by using Internal standard method with Inductively Coupled Plasma Mass Spectroscopy (ICP-MS) in KED (kinetic energic discrimination) mode with diluent concentration nitric acid and Hydrochloric Acid.
Result: 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 Cyclosporin Injection USP.