Application of HPLC in Quality Analysis of Hydroxychloroquine Sulfate

Introduction

Abstract: In this study, methods were established for analysis of hydroxychloroquine sulfate and related substances following European Pharmacopoeia (EP10.0) and for determination of hydroxychloroquine sulfate content in tablet following US Pharmacopoeia (USP 43). Using Shimadzu UHPLC system, well separation was achieved between hydroxychloroquine sulfate and impurity C, as well as between impurity B and impurity C referring to the EP assay. Using Shimadzu HPLC system with reference to the USP assay, the content of hydroxychloroquine sulfate in tablet was determined with achieving the desired peak separation and reproducibility described in the USP.

May 20, 2020 GMT