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<records>

  <record>
    <language>eng</language>
          <publisher>Oriental Scientific Publishing Company</publisher>
        <journalTitle>Biomedical and Pharmacology Journal</journalTitle>
          <issn>0974-6242</issn>
            <publicationDate>2026-09-30</publicationDate>
    
        <volume>19</volume>
        <issue>3</issue>

 
    <startPage>2420</startPage>
    <endPage>2428</endPage>

	 
      <doi>10.13005/bpj/3504</doi>
        <publisherRecordId>73336</publisherRecordId>
    <documentType>article</documentType>
    <title language="eng">Pharmacopeial Quality Assessment of Five Commercially Available Enteric-Coated Esomeprazole Magnesium Tablets in Bangladesh</title>

    <authors>
	 


      <author>
       <name>Sabiha Ferdowsy Koly</name>

 
		
	<affiliationId>1</affiliationId>
      </author>
    

	 


      <author>
       <name>Owaliullah Khan Ovi</name>


		
	<affiliationId>1</affiliationId>

      </author>
    

	 


      <author>
       <name>Rejuan Kaif Rohan</name>

		
	<affiliationId>1</affiliationId>
      </author>
    

	 


      <author>
       <name>Israt Jahan Bulbul</name>

		
	<affiliationId>1</affiliationId>
      </author>
    


	 


      <author>
       <name>Nusratun Naha</name>

		
	<affiliationId>1</affiliationId>
      </author>
    


	 


      <author>
       <name>Sherejad Sanam</name>

		
	<affiliationId></affiliationId>
      </author>
    
    </authors>
    
	    <affiliationsList>
	    
		
		<affiliationName affiliationId="1">Department of Pharmacy, Southeast University, Dhaka, Bangladesh</affiliationName>
    

		
		
		
		
		
	  </affiliationsList>






    <abstract language="eng">Esomeprazole, the optically active S-isomer of omeprazole, is extensively used as a proton pump inhibitor for the treatment of gastroesophageal reflux disease and other gastric acid-related conditions. The present investigation was undertaken to assess the pharmaceutical quality of enteric-coated esomeprazole magnesium tablets available from five different Bangladeshi manufacturers. Evaluation was performed by analyzing key physicochemical characteristics including tablet hardness, friability, disintegration behavior, dissolution performance, and drug content assay. All analyses were conducted according to recognized pharmacopeial procedures to determine the uniformity and quality consistency among the selected brands. During disintegration testing in 0.1N hydrochloric acid for two hours, no tablets showed signs of disintegration, indicating satisfactory integrity of the enteric coating and resistance to gastric conditions. When transferred to phosphate buffer solution (pH 6.8), complete tablet disintegration occurred within 30 minutes for all tested samples. The hardness of tablets ranged between 5.443 and 6.509 kg/cm², demonstrating acceptable mechanical durability. Dissolution testing revealed limited drug release in acidic medium, ranging from 2.54% to 4.45%, which complies with the pharmacopeial requirement where stated the value is of less than 10%. In contrast, dissolution in phosphate buffer (pH 6.8) showed rapid and complete drug release within 60 minutes, with release values ranging from 100.9% to 102.4%. Assay analysis confirmed that the active pharmaceutical ingredient content of all brands remained within the accepted pharmacopeial range of 96.32% to 99.20%. These results suggest that the evaluated brands meet established pharmacopeial quality requirements and are likely to ensure reliable therapeutic effectiveness in the treatment of acid-related disorders.</abstract>

    <fullTextUrl format="html">https://biomedpharmajournal.org/vol19no3/pharmacopeial-quality-assessment-of-five-commercially-available-enteric-coated-esomeprazole-magnesium-tablets-in-bangladesh/</fullTextUrl>

<keywords language="eng">

      
        <keyword>Assay</keyword>
      

      
        <keyword> Dissolution study</keyword>
      

      
        <keyword> Enteric-coating</keyword>
      

      
        <keyword> Esomeprazole magnesium</keyword>
      

      
        <keyword> Pharmacopeial compliance</keyword>
      

      
        <keyword> Quality evaluation</keyword>
      
</keywords>
  </record>
</records>