METHOD VALIDATION FOR DETERMINATION OF HEAVY METALS IN PHYTONADIONE EMULSION (I.M) DOSAGE FORMS BY ICP-MS

• Published in: Journal of atoms and molecules Vol. 2; no. 6; p. 425
• Main Authors: Kantha, M Rose Vineela, Pulicharla, Rama, Sumanth, P, Rao, P Venkateswar, Babu, A M S Sudhakar
• Format: Journal Article
• Language: English
• Published: Chennai Journal of Atoms and Molecules 01.11.2012
• Subjects: Carbon; Chromium; Digestion; Emulsions; Impurities; Pharmaceuticals; Symbols
• ISSN: 2277-1247

The analysis of pharma samples by ICP-MS is challenging due to their high carbon content. Because they are organic based and have a variety of compositions, present a special challenge for ICP-MS analysis: the carbon causes polyatomic interferences and can clog interface cone. Using the NexION... 300 ICP-MS, several pharma compounds (ranging from API's to finished products) were successfully analyzed as per USP232 limits using a single set of calibration standards and operating conditions, demonstrating a validation process for the simultaneous analysis of 7 elements, arsenic, cadmium, mercury, lead, chromium, copper and nickel, in phytonadione emulsion samples by inductively coupled plasma-mass spectrometry (ICP-MS) after closed-vessel microwave digestion. Results indicate that this method could be used in the laboratory for the routine determination of metal impurities in pharmaceutical preparations with acceptable analytical performance. The technique was applied not only for determination of metallic impurities but also the assay of various trace elements in pharmaceuticals. (ProQuest: ... denotes formulae/symbols omitted.)