Quantification of Four Azido Impurities in Losartan Potassium API using LCMS-8045

User Benefits

- A simple and robust LCMS method for the determination of four Azido impurities in Losartan Potassium API. - No complex sample pre-treatment is required.

Introduction

Losartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). It works by relaxing blood vessels so that blood can flow more easily. Losartan has antihypertensive and vasodilatory effects and is prescribed for the treatment of high blood pressure and to help protect the kidneys from damage due to diabetes. It is also used to lower the risk of strokes in patients with high blood pressure and an enlarged heart. The azido impurities are derived from sodium azide, which is a precursor in the synthesis of losartan and classified as a first- class poison. The azido impurities are considered as mutagens. A mutagen is a chemical substance that can cause a change in the DNA of a cell. These mutations may increase the risk of cancer, however the specific risk for these azido impurities to cause cancer in humans is unknown. The risk caused by these azido impurities at the levels detected in sartan medicines till date is very low. However, such contamination is considered unacceptable for a medicine. The actual health risks from these impurities depend on the dose of the medicine and will vary from person to person. Therefore, it becomes necessary to develop a highly sensitive and robust analytical method to detect azido impurities in the losartan drug substances. Considering the risk of cancer and challenges such as the structural similarities between these impurities and losartan drug substance, it is imperative to have a sensitive, reliable & accurate method for determination of azido impurities in losartan drug. This application note describes an LC-MS/MS method for the direct quantification of azido impurities in losartan potassium API.

October 29, 2023 GMT