SULTANA NITA, RAZVAN RUGHINIS, NICOLETA RUS, RODICA BALAS<br>ICP-MS Computer Controlled Determination of some Trace <br>Elements in Pharmaceutical Containers and Substances

SULTANA NITA, RAZVAN RUGHINIS, NICOLETA RUS, RODICA BALAS
ICP-MS Computer Controlled Determination of some Trace
Elements in Pharmaceutical Containers and Substances

Abstract:

The objective of our study has been the determination of eight trace elements in eight pharmaceutical matrices in order to ensure a complete quality control and patient safety. The paper presents computer-controlled ICP-MS methods for determination of cadmium, nickel and lead in different substances (magnesium stearate, stearic acid, talc, sugar, lactose and starch), respectively for vanadium, titanium, chromium, barium and aluminum in various containers (polyethylene, polyethylene terephtalate). Different methods for sample preparation were established, depending on the matrix nature. Microelement concentrations have been measured with ICP-MS equipment (Elan DRC-e, Perkin Elmer). Performance parameters of the methods have been effectuated according to the validation protocol from American Pharmacopeia. Moreover, an automatic Linux network-based backup system was put in place to prevent data loss for critical analyses and to ensure data security. Linearity was established for the range of concentrations between 1-800 ppb, specific for each element (R2=0.9923-0.9998). Limits of detection (0.00024-0.00390 ppm) and limits of quantification (0.00048-0.00780 ppm) have been determined according to the isotope mass. The accuracy of methods, effectuated on samples spiked with known amounts of inorganic impurities, was between 97.1-98.8%. The method precision for each element and respectively for each matrix was satisfactory, in relation to values prescribed for this technique. Results are in concordance with the requirements imposed by the most recent European and British Pharmacopeia editions, regarding the limits and type of the element for the quality control of the containers and pharmaceutical substances. The presented ICP-MS methods allow for the accurate determination of quantitative trace elements in the pharmaceutical field. Keywords: ICP-MS, pharmaceutical substances, containers

Issue: 2009, Volume 60, Issue 4

Pages:

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