Identification of Degradant Products of Saroglitazar by UPLC Tandem Mass Spectroscopy and Attenuated Total Reflection FTIR Techniques

Abstract:

Saroglitazar is a newly approved oral hypoglycemic drug by FDA. Although the drug entered the market, there are no reports on its degradation products till date. To identify the degradation products of saroglitazar during the stability studies, a RP-HPLC method was developed and validated as per ICH guidelines. The samples were eluted using acetonitrile and phosphate buffer (pH 7.4, 50:50 v/v) as a mobile phase over Kromasil 100- 5C18 (250×4.6 mm, 5μm) column. The analytes were monitored by UV detector at 294 nm with isocratic mode of elution at a flow rate of 1.0 mL/min. The stability studies were conducted under stressed conditions of acidic, basic, neutral (peroxide), photolytic studies at room temperature and thermal at 60oC for 48 hours. The stressed samples were analyzed for their degradation products by RP-HPLC. The degradant products obtained were characterized using UPLC with tandem mass spectroscopy (LC/MS/MS) and FTIR. Major degradation products were observed with m/z at 365, 247 and 294. The drug is found to be comparatively stable under photo and thermal stress. Peroxide stress has degraded the drug completely. The drug has to be stored away from oxidation during transport and storage.

Key words: Saroglitazar, Degradation products, Reverse phase high performance liquid chromatography, Mass spectroscopy, Infra-red spectroscopy.