Quantitative analysis of azido impurity in the sartandrugs using LC-MS/MS

AZBT (5-(4`-(azidomethyl)-[1,1`-biphenyl]-2yl)-1H tetrazole) is an azido impurity of sartan drugs known to cause gene mutation which increases risks of developing cancer. Irbesartan, valsartan and losartan, which contained excessive amounts of azido impurities have been recalled in Canada in May 2021. Accordingly, the Ministry of Food and Drug Safety in Korea(KFDA) also announced the ‘AZBT test method for sartan drugs using LC-MS/MS’ and provided the guidelines on the method validation results.[1]The acceptance criteria for system suitability from KFDA method at 1.0 ng/mL of AZBT standard solution were signal to noise(S/N)ratio≥10, relative standard deviation(RSD) for peak areas(n=6)≤10%, coefficients of determination(R2)≥0.995 and symmetry factor ofpeak≤2.0. In this application news, the limit of quantitation(LOQ), linearity, repeatability and recovery for AZBT spiked sartan drugs were evaluated using Shimadzu LCMS-8050 with the KFDA method.