LC-MS/MS Method for Detection and Quantitation of Azido Impurities in Irbesartan Drug Substance

User Benefits

- A method based on the high sensitivity MRM was established for the quantitative determination of azido impurities in irbesartan API with LCMS-8050. - The performance for established method was evaluated in terms of linearity, LOD, LOQ, recovery and the reliable results were obtained.

Introduction

The azido impurity, azidomethyl biphenyl tetrazole (AZBT), known as a mutagenic impurity was detected in sartan-type antihypertensive drug. As a result, drug recalls were carried out by regulatory agencies such as European Medicine Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada. Accordingly, the Ministry of Food and Drug Safety (MFDS) in Korea distributed the LC-MS/MS method for the determination of AZBT in sartan drug substances as a guideline and strives to secure drug safety. Azido impurities can be formed during the synthesis of sartan active pharmaceutical ingredient (API) containing tetrazole rings. In sartan, the tetrazole ring is formed by the reaction between appropriate nitrile and azido groups, which can be accompanied by trace levels of azide impurities as a by-product. There are various types of azido impurities besides AZBT, which is a domestically regulated component. Accordingly, this Application News is intended to present the evaluation of LC- MS/MS method for analysis of 4 azido impurities in irbesartan drug substance.

February 22, 2023 GMT