Abstract

DEVELOPMENT OF ANALYTICAL METHOD AND VALIDATION OF RP-BASED HYDROXYCHLOROQUINE SULFATE TABLET DOSAGE FORM-HPLC

K. Prabhakaran*, A. Mercy Jenifa, G. Yuvaraj, S. Balamurugan, C. Mohanavignesh, G. Thirugnanam and M. M. Yarrish Dharan

ABSTRACT

This study used a recently developed, simple Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC) method to detect and confirm hydroxychloroquine sulfate. Internal standard chromatographic separation was achieved on an ODS (octadecyl-silica) C18 Column (250mm×4.6mm×5μm) with mobile phases 80:20 (A-B), A-(90:10:0.2) (Water: Acetonitrile: Orthophosphoric acid), and B-(20:80:0.1) (Water: Acetonitirile: Orthophosphoric acid) at a flow rate of 1.0 ml/min. The study used 220 nm detection. It took around 3-3.2 minutes for the hydroxychloroquine sulfate to elute, and each sample required 10 minutes of chromatographic analysis. The linear range of 20–100 μg/ml was covered by the standard hydroxychloroquine sulfate calibration curve, which had an R2 value of 0.99981. It was discovered that the intraday and interday accuracyRSDs were 0.1% and 0.2%, respectively. The method was found to be linear, exact, accurate, robust, and specific, and the tablet formulation's purity was found to be 98.70% using the ICH standards as a reference. Since the drug sample recoveries in the experimental formulations were in good accordance with their corresponding label claims and it was found that formulation excipients do not interfere with the estimation, this approach can be easily and simply used for routine analysis of hydroxychloroquine sulfate in a tablet dosage form.

Keywords: Hydroxychloroquine sulfate, RP-HPLC, ODS, ICH guidelines, Orthophosphoric acid, Acetonitrile.