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  • 1 Laboratório de Controle de Qualidade de Fármacos e Medicamentos, Grupo de Pesquisa em Tecnologia e Controle de Qualidade de Medicamentos, Escola de Enfermagem e Farmácia, Universidade Federal de Alagoas—UFAL, Campus A. C. Simões, Br 104 Norte, Km 97, Maceió, Estado de Alagoas CEP 57072-970, Brazil
  • | 2 Laboratórios Unificados de Desenvolvimento e Ensaios de Medicamentos, Departamento de Ciências Farmacêuticas, Universidade Federal da Paraíba—UFPB, Campus I, João Pessoa, Estado da Paraíba CEP 58059-900, Brazil
  • | 3 Laboratório Industrial Farmacêutico do Estado de Alagoas—LIFAL, Av. Salvador Lira s/n, Distrito Industrial Governador Luis Cavalcante, Tabuleiro dos Martins, Maceió, Estado de Alagoas CEP 57082-000, Brazil
  • | 4 Hungarian Academy of Sciences, Budapest University of Technology and Economics, Research Group of Technical Analytical Chemistry, Szt. Gellért tér 4, 1111 Budapest, Hungary
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Abstract  

This article characterizes the stability of indinavir sulfate using different analytical techniques of quality control to evaluate important steps in the manufacturing process of indinavir, specifically involving storage and compression. Indinavir A, B, and C were obtained from different suppliers and submitted to DSC, Karl Fisher, NIR, XRPD analyses and dissolution assay. DSC curves of indinavir presented endothermic peaks of fusion at 149–150 °C for indinavir A and B (form I) and 139–143 °C for indinavir C (form II). When indinavir A and B were submitted to high Relative Humidity (RH) pseudo-polymorphic form II was formed. Indinavir C converted into an amorphous substance when submitted to compression. Near infrared and Karl Fisher assays detected high values of water for indinavir C in relation to indinavir A and B. X-ray powder diffraction of indinavir B and C showed displacement of 0.05–0.10 θ in the peaks and higher angle of diffraction in relation to indinavir A. Amorphous indinavir C demonstrated a higher intrinsic dissolution rate than indinavir A and B. Indinavir form I should be monitored during the pharmaceutical process to avoid its conversion to indinavir form II or an amorphous substance which can alter the dissolution rate.

Manuscript Submission: HERE

  • Impact Factor (2019): 2.731
  • Scimago Journal Rank (2019): 0.415
  • SJR Hirsch-Index (2019): 87
  • SJR Quartile Score (2019): Q3 Condensed Matter Physics
  • SJR Quartile Score (2019): Q3 Physical and Theoretical Chemistry
  • Impact Factor (2018): 2.471
  • Scimago Journal Rank (2018): 0.634
  • SJR Hirsch-Index (2018): 78
  • SJR Quartile Score (2018): Q2 Condensed Matter Physics
  • SJR Quartile Score (2018): Q2 Physical and Theoretical Chemistry

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Journal of Thermal Analysis and Calorimetry
Language English
Size A4
Year of
Foundation
1969
Volumes
per Year
4
Issues
per Year
24
Founder Akadémiai Kiadó
Founder's
Address
H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
Publisher Akadémiai Kiadó
Springer Nature Switzerland AG
Publisher's
Address
H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
CH-6330 Cham, Switzerland Gewerbestrasse 11.
Responsible
Publisher
Chief Executive Officer, Akadémiai Kiadó
ISSN 1388-6150 (Print)
ISSN 1588-2926 (Online)