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Quality Assessment of Hydroxychloroquine Tablet: A Comparative Evaluation of Drug Produced by Different Pharmaceutical Companies in Bangladesh
Md. Raihanur Islam, Dr. Sharifa Sultana, Mohammad Touhidul Islam,

"Hydroxychloroquine  is  the  most  commonly  prescribed  antimalarial  extensively used to treat rheumatoid arthritis. It is extensively utilized as a repurposing drug, as well, in many countries worldwide to treat COVID-19. The pharmaceutical sector of Bangladesh is much  enriched,  and  different  pharmaceutical  companies  in  Bangladesh  produce  this  drug. Since the drug quality might vary significantly among different brands, assuring the quality 

PMMB 2023, 6, 1; a00003362of 11of  medicine  is  absolutely  necessary  considering  the  health  issues,  particularly  therapeutic efficacy  and  safety.  Therefore,  this  study  examined  the  quality  of  hydroxychloroquine produced  by  Bangladeshi  pharmaceutical  companies,  concentrating  on  quality  control parameters: the assay, dissolution, disintegration, hardness, friability, and weight fluctuation. All  the  brands  of  hydroxychloroquine  tablets  contained  the  stated  amount  of  API  between the range of 96.41±0.62 and 100.61±0.71 that met USP specification (100±5%). All brands met the pharmacopeial limit for the percentage of weight fluctuation, hardness test, friability, and  disintegration  time.  Weight  variation  was  between  0.31±0.01%  and  0.46±0.02%, hardness  was  between  4.31  ±  0.88  and  7.36  ±  0.74  kgf,  friability  was  less  than  1%,  and disintegration time was 5.42± 0.11 and 5.42± 0.11 min. In the dissolution test, all the samples attained   more   than   70%   dissolution   after   30   minutes.   The   mean   percentage   of hydroxychloroquine  released  in  phosphate  buffer  was  between  95.44±0.55  (Brand  B)  and 98.19±0.39  (Brand  C)  after  60  min. No significant  difference  wasamong  the  tested  drugs from   different   companies,   and   all   quality   assessment   parameters   were   within   USP specifications.  Therefore,  hydroxychloroquine  from  the  Bangladesh  market  is  safe  and effective"

Journal or Conference Name
Progress in Microbes and Molecular Biology
Publication Year