Elemental Impurities Estimation in Adenosine Injection using ICP-MS

Diagnostic property and therapeutic property makes adenosine a preferable agent. Through purinergic adenosine receptors; adenosine works pharmacologically. Due to its vasodilatory effects, myocardial perfusion stress imaging done by adenosine that finds its use as a diagnostic agent. Antiarrhythmic properties of adenosine finds its use in supraventricular tachycardia (SVT) as therapeutic agent. Drug product may have elemental impurities from different sources. As such elements other than supplements do not provide therapeutic effects, therefore pharmaceutical agencies emphasize to control their levels within acceptable limits. To have elemental impurities within limits; ICH Q3D guideline and USP general chapter 232 recommends specification limits for different elemental impurities on the basis of their toxicity level, route of administration and daily intake. For determination of elemental impurities in adenosine injection as per ICH guidelines is developed and validated by ICP-MS. Limit used for determination were adopted as per ICH guideline considering daily intake of 25 g/day. Adenosine injection belongs to parenteral dosage form therefore analysis was carried out for determination of cadmium, arsenic, mercury, lead, vanadium, cobalt, nickel, lithium, antimony and copper. Standards were prepared at 5 levels from 50% to 150% of target concentration along with 25% level analysed as control threshold. Correlation coefficient in linearity for all 10 elements were found to be more than 0.990 and system suitability recovery was found to be well within acceptable range of 70% to 150% for all 10 elements. Validation of method was performed by demonstrating specificity, accuracy by recovery, LOQ recovery and intermediate precision.