Forced Degradation Studies on Trandolapril and Development of a Stability-indicating related Substances High Performance Liquid Chromatography Method in Presence of its Degradation Compounds

Rajendra S. Chavan; Ajay Thakur; Qasim Ullah; Sabreena Yameen; Pathan Mohd Arif

doi:10.25004/IJPSDR.2023.150105

Rajendra S. Chavan Wockhardt Research Centre, Aurangabad, Maharashtra, India
Ajay Thakur Department of Chemistry, Shaheed Captain Vikram Batra Government College, Palampur, Himachal Pradesh, India
Qasim Ullah Physical Sciences Section, School of Sciences, Maulana Azad National Urdu University, Hyderabad, Telangana, India
Sabreena Yameen Department of Chemistry, Maulana Azad College, Aurangabad, Maharashtra, India
Pathan Mohd Arif Department of Chemistry, Maulana Azad College, Aurangabad, Maharashtra, India

DOI: https://doi.org/10.25004/IJPSDR.2023.150105

Keywords: High-performance liquid chromatography, Method development, Stability indicating, Trandolapril, Validation.

Abstract

In present studies high-performance liquid chromatography (HPLC) method for trandolapril is developed and subsequently validated. The method utilizes an Xterra MS C18 column at 35°C temperature, gradient elution with aqueous potassium dihydrogen phosphate having pH-3.0 by orthophosphoric acid and combination with acetonitrile as the mobile phase. We are reporting here simultaneously the separation of all related impurities and degradation products of trandolapril formed under different stress conditions as per ICH Q1A (R2) guideline. Trandolapril showed labile behavior in acidic, basic and oxidative stress conditions. The developed method was extensively validated and proved to be robust. The developed method has shown excellent linearity over the range from 0.10 to 3.0 μg/mL. The correlation coefficient(r) is 0.999. The % recovery value of trandolapril and their two impurities ranged from 97.98 to 100.55%, respectively.