DETERMINATION OF FOURTEEN PREFERRED ELEMENTAL IMPURITIES EMPLOYING ICP-MS AND MICROWAVE ACID DIGESTION APPROACH IN PARENTERAL OFLOXACIN SAMPLES

Abstract

The method of “Inductively Coupled Plasma Mass Spectrometry” (ICP-MS) may be interpreted as a trend in pharmaceutical determination of elemental impurities. The development of a specific process that is precise for all elemental impurities, however, is still a task. The ICP-MS technique using microwave acid digestion as a sample processing method was used to determine 14 elemental impurities (lithium, vanadium, chromium, manganese, iron, cobalt, nickel, copper, arsenic, molybdenum, cadmium, antimony, mercury and lead) existing in parenteral ofloxacin in this study. The strategy proposed was verified as per “United States Pharmacopeia Convention”. The detection limits achieved by the proposed approach suggest that the ICP-MS technique is quite well fit for the measurement of the 14 chosen elemental impurities. Good linearity was achieved with correlation coefficient values higher than 0.99 over the range of quantification limit level concentration to 200 % level of the individual elemental impurity specification values. The values obtained for accuracy, precision, robustness, selectivity and ruggedness are also satisfactory. Six distinct batches of parenteral ofloxacin samples were subjected to analysis by the ICP-MS technique proposed. In all the batch samples, the fourteen chosen elemental impurities were noticed to be less than detection levels.