METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF CLASS-I ELEMENTAL IMPURITIES IN PROPOFOL EMULSION USING ICP-MS

Elemental impurities are the traces of metals that can be found in finished drug products which may enter through various sources like excipients, and active pharmaceutical ingredients etc., their toxicity is to be estimated as they may pose serious toxicological effects to patients. The aim of this work is to estimate Class-I elements (Cd, Pb, As, Hg) simultaneously in Propofol 10 mg/mL Emulsion for Injection or Infusion using modern technique Inductively coupled plasma mass spectrometry, employing microwave-assisted digestion of sample. The developed method was validated for various parameters according to ICHQ2(R1) to prove that the developed method is fit for the required purpose and can be adaptable regularly. Validation results showed that the method was linear over the range of LOQ to 250%, with a good linearity correlation factor of R≥0.99, the method was found to be robust against the deliberate changes in sample preparation and uptake speed.