DISSOLUTION PROFILE ICH SERIES
DISSOLUTION PROFILE ICH FREE

In recent days, it is proven to have the superficial ability and tolerable safety against coronavirus disease 2019 (COVID-19)-related pneumonia in clinical experiments performed in China ( Gao et al., 2020) and other parts of the world. Moreover, HCQ has in vitro activity for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and related coronaviruses problems ( Colson et al., 2020 Wang et al., 2020 Yao et al., 2020). HCQ is mainly used as a medication for malaria and a wide variety of inflammatory conditions. It is easily soluble in water and organic solvents. Hydroxychloroquine (HCQ) is a white crystalline powder, chemically named 2-pentyl-ethylamino]ethanol. The proposed RP-HPLC generic method was applied successfully to evaluate the in vitro dissolution profile with different pH conditions such as 0.1 N HCl, pH 4.5 acetate buffer, and pH 6.8 phosphate buffers as US-marketed reference products. The relative standard deviations for precision and intermediate precision were <1.5%. The concentration and area relationships were linear ( R 2 > 0.999) over the concentration range of 25вЂ“300 Ојg ml в€’1 for hydroxychloroquine (HCQ). As part of method validation, specificity, linearity, precision, and recovery parameters were verified. The reversed-phase high-performance liquid chromatography (RP-HPLC) method has been developed and validated as per the current International Conference on Harmonization (ICH) guidelines to estimate hydroxychloroquine sulfate tablets. Detection was made at 254 nm by using a dual absorbance detector (DAD). The flow rate was 1.0 ml min в€’1, and injection volume was 10 Ојl. Mixed buffer, acetonitrile, and methanol (800:100:100 v/v). The buffer consists of 0.01 M of 1-pentane sulfonic acid and 0.02% of orthophosphoric acid in purified water. The chromatogram separation was achieved by using Agilent, Zorbax C8, 250 mm Г— 4.6 mm i.d., column. Based on recent clinical experiments, it is exploited for the treatment of COVID-19, coronavirus across the globe. Sometimes, hydroxychloroquine sulfate is beneficial for the treatment of autoimmune diseases. Moreover, it is used for the treatment of rheumatoid arthritis.

DISSOLUTION PROFILE ICH SERIES

Hydroxychloroquine sulfate is one of an extensive series of 4-aminoquinolines with antimalarial activity.

7School of Pharmaceutical Sciences, Shoolini University of Biotechnology and Management Sciences, Solan, India.

6Priority Research Centre for Healthy Lungs, Hunter Medical Research Institute (HMRI) & School of Biomedical Sciences and Pharmacy, The University of Newcastle (UoN), Callaghan, NSW, Australia.

5Discipline of Pharmacy, Graduate School of Health, University of Technology Sydney, Ultimo, NSW, Australia.

4School of Pharmacy and Pharmaceutical Science, Ulster University, Coleraine, United Kingdom.

DISSOLUTION PROFILE ICH FREE

3Department of Chemical Pathology, Faculty of Health Sciences and National Health Laboratory Service, School of Pathology, University of the Free State, Bloemfontein, South Africa.2Department of Chemistry, School of Science GITAM Deemed to be University, Hyderabad, India.1Aurex Laboratories LLC, East Windsor, NJ, United States.The later part highlights the concepts of dissolution profile comparison, IVIVC and BCS (integrating with QbD), and their roles from nonclinical to the postmarketing stage of drug development to ensure a high-quality biopharmaceutical product of desirable attributes.Thirupathi Dongala 1,2, Naresh Kumar Katari 2 *, Santhosh Kumar Ettaboina 1, Anand Krishnan 3, Murtaza M. The initial part of the chapter outlines the development of a relevant dissolution test taking into consideration all the parameters that influence its performance and results. This chapter highlights the significance of the dissolution and the related concepts throughout the pharmaceutical drug development continuum. It is considered as an important tool used in formulation development and optimization estimation of drug release under physiological conditions assurance of batch-to-batch consistency stability monitoring bioequivalence determination between pharmaceutical formulations. It reduces regulatory burden, resource requirements, and thus development times and cost in the long, arduous, and expensive process of formulation development. Dissolution testing has been evolved as an approach based on risk and science, to control the quality of pharmaceutical dosage forms, as well as to assist pharmaceutical product development, approval, and postapproval dossier submissions.

Dissolution profile ich