Identification and structural characterization of lactose adduct impurities in isosorbide dinitrate and hydralazine hydrochloride tablets by liquid chromatography‐mass spectrometry and nuclear magnetic resonance studies

Author:

Muppavarapu Venkatarao12ORCID,Challa Gangu Naidu13ORCID,Gande Mukteeshwar2,Billa Praveen Reddy2,Joshi Venkatesh Madhavacharya2,Ch Thirupathi4,Ponnapalli Veerabhadra Swamy4,Y Srinivasa Rao5

Affiliation:

1. Department of Chemistry School of Applied Science and Humanities Vignan's Foundation for Science Technology and Research University (VFSTR) Guntur India

2. Analytical Research and Development (AR&D) RiconPharma India Private Limited Hyderabad India

3. Department of Basic Sciences and Humanities (B S&H) Vignan's Institute of Information Technology (VIIT) Visakhapatnam India

4. Analytical Research and Development (AR&D) Daicel Chiral Technologies Private Limited Hyderabad India

5. Department of Pharmaceutics Vignan Institute of Pharmaceutical Technology (VIPT) Visakhapatnam India

Abstract

AbstractIsosorbide dinitrate and hydralazine hydrochloride tablets are approved for the treatment of heart failure, prolonged hospitalization for heart failure, and enhanced patient‐reported functional status. It has been administered orally. Isosorbide dinitrate and hydralazine hydrochloride tablets contained two additional major unknown peaks (Degradation Product 1 and Degradation Product 2) in the stability studies (25°C/60% relative humidity and 40°C/75% relative humidity). These two unknown degradation peaks formed due to the heat (thermal) and humidity stress of hydralazine hydrochloride. Liquid chromatography separated these unknown degradant peaks. Initially, liquid chromatography‐mass spectrometry assessed the degradation pathways and mass of two degradants. Afterward, preparative‐liquid chromatography isolated the two major unknown degradation impurities formed under heat (thermal) and humidity stress conditions. Further, to confirm the structures, nuclear magnetic resonance spectroscopy evaluated these two degradants. The liquid chromatography‐mass spectrometry and nuclear magnetic resonance spectral data confirmed that the two degradation impurities are hydralazine lactosone ring‐opened adduct (Degradation Product 1) and s‐triazolo [3,4‐α] phthalazine (Degradation Product 2).

Publisher

Wiley

Subject

Filtration and Separation,Analytical Chemistry

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