Abstract :
Impurity is defined as any substance coexisting with the original drug. Control of toxic impurities in drug substances has received more and more attention over the past years. These are to be determined based on the maximum daily dose. According to EMEA guidelines, a TTC value of 1.5 microgram/day intake of a toxic impurity is considered to be associated with an acceptable risk. The concentration limits in ppm of permitted toxic impurity in a drug substance is the ratio of TTC in microgram/day and daily dose in gram/day. Impurities present in excess of 0.10% should be identified and quantified by selective methods. In Aprepitant (APT) drug substance, Methyl-p-toluene sulphonate (MPTS) was suspected to carried from raw materials. The maximum daily dose of Aprepitant is 125 mg /day. From this TTC level has found to be 12ppm. In literature, no method was reported for the determination of this impurity. From the above calculation, the present studies are aimed towards the determination of this compound in Aprepitant at the level of 12 ppm (lower end) by Ultra Performance Liquid Chromatography. And the proposed UPLC method was validated as pre-ICH Guidelines and the following parameters are studied System Suitability, Specificity, LOD, LOQ, Linearity, Batch analysis, Precision, LOQ recovery, LOD recovery.
Keyword :
Ultra Performance Liquid Chromatography, Aprepitant, impurity