LC-MS/MS Method for Detection and Quantitation of Azido Impurity in Valsartan Drug Substance

User Benefits

- The method involves the use of LC-MS/MS for the analysis of azido impurity in the sartan drugs. - The method performances such as linearity, LOD, LOQ, repeatability and recovery were evaluated. - An MRM based method with superior sensitivity and repeatability helps to ensure reliable laboratory operations.

Introduction

Sartan drug substances, including valsartan, losartan, and irbesartan, are primarily used to treat high blood pressure and kidney failure. These block the action of angiotensin II, which regulates blood pressure by narrowing blood vessels and triggering water and salt intake. Recently, sartan drug substances which contained excessive amounts of azido impurities were recalled in some countries. Azido impurities with azide groups are known to be a mutagenic and potentially carcinogenic substance. Accordingly, the Ministry of Food and Drug Safety in Korea (MFDS) announced the ‘AZBT test method for sartan drugs using LCMS/MS’ and provided the guidelines on the method validation results to decide to ensure safety of drugs. This application news describes the evaluation of LC-MS/MS method for analysis of four azido impurities (AZBC, AMBBT, AMBBC and AZBT) in valsartan drug substance.

May 14, 2023 GMT