Journal of Analytical & Bioanalytical Techniques
Open Access

Abstract

The present study reports the degradation behavior of hydroxychloroquine (HCQ) under the conditions of hydrolysis (acid, alkali and water), oxidation (30% H 2 O 2 ), dry heat and photolysis (UV-VIS light) in accordance with the ICH guidelines. HCQ and all six degradation products formed under alkaline photolytic conditions were optimally resolved on an XTerra� RP18 column with mobile phase composed of methanol, acetonitrile and ammonium formate buffer (20mM, pH 4.5) in an isocratic mode. The drug was stable in all other forced condition. The products were characterized through +ESI-MS n and LC-ESI-MS- TOF and LC-PDA data of the drug as well as degradation products. The products I-IV were characterized as N-oxide HCQ, dechlorinated HCQ, N-desethylated HCQ and N-dealkylated HCQ. The product I and VI were not characterized due to limited data. This library of HCQ degradation products provides a foundation for further product development and stability monitoring.

Biography

Balraj Saini has completed his M. Pharmacy from Punjabi University, Patiala and pursuing PhD from the same university under the supervision of Dr. Gulshan Bansal. He has been worked as Research Associate in Jubilant Chemsys Ltd., Noida, Uttar Pradesh, India for a period of 1year 9 months. His areas of interest include characterization of impurities/degradation products in drug substances through chromatographic and spectral techniques. He is proficient in HPLC method development and validation and in interpretation of mass spectral data. He has published 3 papers in reputed journals.