Stability Indicating LC Method Development for Hydroxychloroquine Sulfate Impurities as Available for Treatment of COVID
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ORIGINAL
Stability Indicating LC Method Development for Hydroxychloroquine Sulfate Impurities as Available for Treatment of COVID‑19 and Evaluation of Risk Assessment Prior to Method Validation by Quality by Design Approach Thirupathi Dongala1,2 · Naresh Kumar Katari2 · Ashok Kumar Palakurthi1 · Lakshmi Narasimha Rao Katakam3 · Vishnu Murthy Marisetti4 Received: 3 March 2020 / Revised: 18 July 2020 / Accepted: 7 August 2020 © Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract A quality by design-based stability indicating HPLC method has been developed for hydroxychloroquine sulfate impurities. The optimized HPLC method can detect and quantify the hydroxychloroquine sulfate and related organic impurities in pharmaceutical solid oral dosage forms. Nowadays, for the quantification of impurities in drug products demands more comprehensive way of analytical method development. The quality by design approach allows the assessment of different analytical parameters and their effects with minimum number of experiments. A highly sensitive and stability indicating RPHPLC method was developed and evaluated the risk assessment prior to method validation. The chromatographic separation was achieved with X-terra phenyl column (250 × 4.6 mm, 5 µm) using phosphate buffer (0.3 M and pH 2.5). The gradient method flow rate was 1.5 mL min−1 and UV detection was made at 220 nm. The calibration curve of hydroxychloroquine sulfate and related impurities were linear from LOQ to 150% and correlation coefficient was found more than 0.999. The precision and intermediate precision % RSD values were found less than 2.0. In all forced degradation conditions, the purity angle of HCQ was found less than purity threshold. The optimized method found to be specific, accurate, rugged, and robust for determination of hydroxychloroquine sulfate impurities in the solid oral dosage forms. Finally, the method was applied successfully in quality control lab for stability analysis. Keywords Hydroxychloroquine sulfate · Quality by design · Design of experiments · HPLC · Validation
Introduction Hydroxychloroquine sulfate (HCQ) is one of a large series of 4-aminoquinolines with antimalarial activity [1, 2]. Moreover, it is used for the treatment of rheumatoid * Thirupathi Dongala [email protected] 1
Analytical Research and Development, Aurex Laboratories LLC, 10 lake drive, East windsor, New Jersey 08520, USA
2
Department of Chemistry, GITAM University, Hyderabad, Telangana 502329, India
3
Analytical Development, Saptalis Pharmaceuticals LLC, Hauppauge, NY 11788, USA
4
Analytical Research and Development, ScieGen Pharmaceuticals Inc, 89 Arkay drive, Hauppauge, NY 11788, USA
arthritis. Sometimes HCQ is very effective for the treatment of autoimmune diseases. Some of the experiments on HCQ are being performed in terms of its capability to inhibit some of the corona virus. There is a wide range of interest in the use of HCQ, which is commonly available for the potential interventions for COVID-19. Health agencies w
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